Screening and Preparing for a Study Visit

There are several steps that must be taken prior to conducing a study visit..

Many human subject protocols require participants to be scheduled for specific research visits. The number and length of time required for a research appointment to occur is highly dependent on the specifics of the study design. The specifics of the appointment are highly dependent on the location of the appointment. Appointments can occur in inpatient units, outpatient clinics, lab draw locations, diagnostic testing locations, research labs, Clinical Research Center (CRC), at the participant’s home or a neutral site convenient for the participant. The visits where the study will occur must be listed with the IRB.

It is important to set the expectations of each visit for the participant. For example, where the visit will take place, how long the visit will take, tasks to be completed at the visit, what tasks are clinical vs. what is research related, special instructions the participant must follow prior to the visit, directions and parking information, whether or not compensation for time or parking will take place and who will be involved in the visit. This should all be included in a confirmation letter.  

Access Screening Letter

Access Confirmation Letter

Access Confirmation Letter 2

Once the visit is scheduled, follow-up contact within a week prior to the visit by a phone call to the participant. It is essential to reinforce the requirements of the study and ensure there has not been any changes since the last time you spoke (broke a leg, new infection, changed medication). Some of these changes might make the patient ineligible and would be better to catch ahead of time.  

It is important to be understanding of the participant’s personal schedule and to help identify research visit times that are convenient for the individual to commit to without sacrificing protocol compliance.  If the study lasts a while and you know the study visit windows, it is good to provide it to the subject to help them plan ahead of when you might want them to come back for visits.  

Access Schedule Template

Access Subject Schedule by Enrollment

Prior to each study visit, the research team must be prepared for all known and unknown tasks that may need to be completed per protocol. If applicable, physician orders need to be completed and authorized for lab draws, study medication and additional testing; research lab kits should be prepared and available to the appropriate clinical team drawing the samples; participant questionnaires should be prepared; flowsheets required for research documentation should be made available to the appropriate team members; and any end of study visit items should be readily available if the participant decides to withdraw from the study or is removed from the study due to adverse events or investigator discretion, etc.

Access Checklist Screening

Access Checklist Follow-up

Obtaining a Medical Record Number

A medical record number (MRN) needs to be assigned to a research participant if they will be admitted to the hospital in the outpatient or inpatient setting or if they will undergo any medical tests that need to be processed by a hospital lab. When first scheduling the participant, research staff can check whether a medical record number already exists for the individual by checking IHIS. If they have a medical record number, that number will be used to identify them for any hospital-related admissions or tests. If they do not have a medical record number you are able to create a new patient in IHIS. Talk with your clinical research manager about how your department wants the new MRN to be created. 

Clinic Visits

Many studies at Ohio State recruit research participants from patients that are already scheduled for healthcare visits in the medical center or cancer center. If the study design is such that these visits can serve the dual purpose of study visit and doctor visits, then scheduling is relatively straightforward and involves coordinating with the clinical treatment team. Clinic and diagnostic testing appointments are scheduled in IHIS, the provider scheduling database. The research team can review the electronic medical record, for specific information on the visits scheduled. It is important to review the participant visits often, as they could be altered or canceled by someone else which may result in protocol compliance concerns or impact the anticipated activities for that day.  

For research appointments that need to be scheduled in the Ohio State hospital or clinics, independent of the patient’s medical appointments, most of the scheduling is done by the hospital schedulers or you might have a point person to ensure you have the correct staffing needed for the research visit. However, it is still the responsibility of the research staff to communicate the specifics of the protocol visit, including the timing of the visits scheduled, how long visits are expected to take, complete any paperwork necessary, obtain physician order for lab or special testing that needs to be performed at a given visit.

Research Appointments

Many studies require that research visits take place in a location that is specifically equipped to carry out the research protocol. Space may be designed to administer specific computer questionnaires, to conduct interviews in a private setting, to be proximal to labs for obtaining and processing blood or other biological specimen or to medical equipment like research CT scans or MRI equipment that cannot be moved. Sometimes certain controlled environment or conditional experiences are part of the research visit. These visits will be arranged with the key research staff involved in the research visit and may not be formally scheduled in the medical center scheduling system. This can cause patients to get reminder calls about a research procedure that happens later in the day and it is separate from the time/location you had discussed for the consent procedure visit to take place. It is essential to send a research confirmation letter that lists the procedures to help clarify to the who, what when and where for the entire study visit.

Scheduling Clinical Research Center (CRC) Visits

The Clinical Research Center in Davis Hall is an inpatient/outpatient hospital nursing unit designated exclusively for research protocols. It is specifically designed to assist investigators with protocols that require nursing, bio-nutritional and/or biostatistical services. In order to utilize the CRC, a specific application needs to be submitted via the Center for Clinical and Translational Science (CCTS). A study calendar highlighting the details of protocol tests, personnel and specific services needed, including the number and length of visits need to accompany the request for services form. The research team will work closely with the CRC staff including the Nurse Manager and Lead Nurses to plan requirements for CRC visits. Once visit requirements are finalized, the research team works closely with the Schedule Coordinator to set up study visits.

When scheduling a participant in the CRC, specific information about the participant needs to be communicated regarding the protocol name, protocol visit type, participant name, date of birth and medical record number. It is important to ensure all CRC study activities and approvals are in place prior to requesting to schedule the first participant for a CRC visit. A copy of specific scheduling guidelines will be sent to the research team if working with the CRC staff on a protocol. 

You can visit the CRC study start page here:  go.osu.edu/crcnewstudy 

Scheduling Off-Site Research Visits

There are research studies that allow the visits to take place in the participant’s home or another neutral location, more convenient for the individual. Off-site study visits pose some additional challenges to the research staff in the form of feasibility and safety.

Before scheduling a home visit, the research staff must assess if the visit tasks can be accomplished in the specific location. For example, is there a workspace sufficient to carry out lab draws and physical examinations, are there electrical outlets for medical equipment or laptop computers, etc. 

The distance away from the study center needs to be taken into consideration as many studies have a travel limit for outreach research staff. Distance can also cause some feasibility issues such as timeframe that blood specimens must be processed to maintain the integrity of the sample. Other things to consider include how the data will be transported to and from the home or off-site study visit. If laptops are used to transport data, they need to be encrypted to ensure HIPAA compliance.

Safety is also a necessary consideration when conducting home visits. When a member of the research team goes to an unfamiliar area to conduct a study visit, at least one other coworker should know that the appointment is occurring. The researcher should communicate with the research team immediately before and after the study visit occurs. The safety of the research staff should always be the primary consideration over the completion of a study visit outside the research study center and appropriate judgment should be utilized.

Lab Result Reviews

When you receive lab reports your investigator will need to document that they have been reviewed. On any abnormal lab value the investigator must document if it is clinically significant.  If it is documented as clinically significant then you will need to create an Adverse Event form. Sometimes the lab is related to other areas of the patient’s medical history so if it is abnormality, it can be documented as such. Great investigator write on the first batch of labs what the abnormal lab value correlates with in subject’s medical history (ie elevated glucose=subject is diabetic) so that reviewers can see that they reviewed all abnormalities seriously.  

Below is a link to a sticker you can attach to printed reports that quickly documents that the investigator has reviewed the labs and then have your investigator sign off on it.   

Abnormal Lab Result Sticker

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  • About the Clinical Operations to CDMS Vault Connection
  • Configuring the Clinical Operations to CDMS Vault Connection
  • CTMS Overview
  • Blinded & Unblinded Content Administration (CTMS)
  • Creating Blinded & Unblinded Content (CTMS)
  • Clinical CRM
  • Configuring Clinical CRM
  • Configuring Risk Based Study Management (CTMS)
  • Configuring Yuzu Clinical Trial Notifications in CTMS
  • Defining Subject Visits in CTMS
  • Issue Management Administration in CTMS
  • Issue Management in CTMS
  • Managing Subject & Enrollment Metrics Jobs (CTMS)
  • Monitoring Schedules (CTMS)
  • Risk Based Study Management (RBSM) in CTMS
  • Subject & Enrollment Metrics in CTMS
  • Subject Recruitment Planning in CTMS
  • Trip Report Administration in CTMS
  • Using the CRA Homepage in CTMS
  • Using the EDC Connection in CTMS
  • Using the Study Manager Homepage in CTMS
  • Working with Trip Reports in CTMS
  • Yuzu Clinical Trial Notifications in CTMS
  • eTMF Overview
  • About the Model & Artifact Objects (eTMF & CTMS)
  • Archiving Studies in eTMF
  • Auto-Filing Documents in TMF Binders
  • Bulk Creating Study Binders (eTMF)
  • Configuring for Study Archival in eTMF
  • Configuring the TMF Homepage
  • Configuring the TMF Viewer
  • Configuring Quality Issues (eTMF & Study Startup)
  • Managing Locations
  • Managing Studies with Lifecycles in eTMF
  • Managing the TMF Index
  • Setting Up CRF Import in eTMF
  • Setting up TMF Transfer
  • TMF Homepage
  • TMF Transfer
  • Using CRF Import in eTMF
  • Working with EDLs
  • Configuring EDLs (Clinical Operations)
  • Evaluating TMF Bot Auto-classification Models
  • TMF Bot FAQ (eTMF)
  • Training Auto-classification Models for TMF Bot (eTMF)
  • Using the TMF Bot (eTMF)
  • Evaluating Metadata Extraction Models
  • Testing Metadata Extraction Models
  • Using TMF Bot Document Quality Control
  • Vault Payments Overview
  • Configuring for Study Budget Tracking
  • Configuring Vault Payments
  • Setting Up Studies for Site Payments
  • Study Budget Tracking with Vault Payments
  • Study Startup Overview
  • About the Model & Artifact Objects (Study Startup)
  • Auto-Filing Documents in Study Startup Binders
  • Clinical Application Management
  • Configuring Surveys for External Respondents
  • Setting Up Site Activation Progress View
  • Site Feasibility in Study Startup
  • Using Site Activation Progress View (Study Startup)
  • Using the Study Startup Specialist Homepage
  • Working with Surveys for External Respondents
  • Veeva Site Connect Overview
  • Configuring Document Reconciliation (Veeva Site Connect)
  • Configuring Safety Distributions
  • Configuring Veeva Site Connect
  • Distributing Safety Documents with Veeva Site Connect
  • Document Reconciliation (Veeva Site Connect)
  • Document Transfer Behavior with Veeva Site Connect
  • Sending Documents & Document Requests (Veeva Site Connect)
  • Setting Up Study Site Agreements for Veeva Site Connect
  • SiteVault Inviter
  • Veeva eConsent Overview
  • Configuring Veeva eConsent Authoring (Clinical Operations)
  • Veeva eConsent Authoring (Clinical Operations)
  • Using the Veeva eConsent Editor
  • Veeva ePRO Overview
  • Using MyVeeva Studio
  • Using a Collection
  • Using Survey Libraries
  • Configuring Surveys
  • Configuring Conditions
  • Configuring Scores
  • Managing Groups
  • Managing Events
  • Configuring Schedules and Notifications
  • Managing Languages and Translations
  • Performing User Acceptance Testing (UAT) on a Collection
  • Approving, Upversioning, and Deleting a Collection
  • Connecting a SiteVault to Your Collection
  • Exporting Survey, Adherence, and Audit Trail Data
  • Changing Survey Data
  • Sample JSON Survey, Schedule, and Notification Templates

Working with Milestones (Clinical Operations)

Vault Milestones specify important points in time at the study, study country, and study site levels. During the course of a study, you accumulate documents of various types. By associating milestones with documents, you can measure milestone completeness by reporting on the status of the study’s documents and those documents’ milestones.

Note : This feature is only available on Clinical Operations Vaults.

How to Create Milestones

Milestone object records define your individual milestones. You can modify these in the same way as other object data records .

Even if you created milestones from a template , you can still add individual milestones.

Each milestone object record includes the Study , Study Country , or Study Site to which the milestone applies. The object record also specifies the planned and actual start and finish dates, the milestone type, and other milestones that share dependencies.

When creating or editing Milestone object records, you’ll need to fill the following object fields:

Note : Depending on your Vault’s version, application, and configuration, you may have different field labels on Milestone and its related objects.

Milestones & Monitoring Events (CTMS)

In CTMS, Monitoring Event records have a Milestone object reference field. You can select a Milestone from this field to associate that milestone to the monitoring event. If you don’t select a Milestone , Vault creates a Milestone record of the correct type automatically after you save your Monitoring Event record. Depending on the object type of your Monitoring Event record, Vault creates different types of Milestones . For example, if you create a Pre Study Visit monitoring event, Vault creates a Pre Study Monitoring Visit milestone. Keep in mind that Vault only creates Milestones for the following standard monitoring event types: Interim Monitoring Event , Pre Study Visit , Site Close Out Visit , and Site initiation Visit .

Vault auto-populates the Study , Study Country , and Study Site fields on the new Milestone record. If your Vault has additional required fields on the Milestone object, the Milestone record creation fails. Vault sends you a notification for the failure. Note that Vault still creates the Monitoring Event record even if the Milestone record creation fails.

About Milestones from Templates

You can create Milestones in bulk using milestone templates . Template Milestones , Milestone Dependency Templates , and Template Tasks are grouped in a single Template Milestone Set object record, similar to ELDs. Once an Admin creates a Template Milestone Set , you can use it to create milestones in bulk at any level. You can create milestones from a template at the start of your study using the Create Milestone from Template action. When your study is in progress, and you require additional milestones to represent ad hoc events, such as a protocol amendment, your Vault may have Story Events configured to create milestones.

How to Create Milestones from Templates

  • Select Create Milestones from Template from the Study , Study Country , or Study Site’s Actions menu. The Create Milestones from Template dialog opens.
  • Click Continue .

Vault creates Milestones from the template at the Study level and adds the associated Milestones to the Study Country and Study Site levels. After Vault creates Milestones , it checks to see if the associated Study has an EDL Template record associated with it. If it does, Vault will use that EDL Template when creating EDL Item records.

If the milestone template has its own EDL Template associated to it, Vault ignores it and uses the EDL Template at the Study level.

  • After the asynchronous job completes, you’ll receive a notification.

Milestones & Story Events

Depending on your Vault’s configuration, you can create milestones and EDLs for ad hoc events in your study using Story Events . Story Events represent different points in time during your Study , such as Site Selection or Protocol Amendment . They include templated milestones, milestone dependencies, and EDL items.

  • Select Apply Milestone Template from the Study , Study Country , or Study Site ’s Actions menu.
  • Select a Story Event to use for milestone and EDL creation.
  • Vault creates milestones and EDLs from templates related to the Story Event at the Study level, and adds the associated milestones and EDLs to the Study Country and Study Site levels.

You can use the Apply Milestone Template action during any lifecycle states it is configured for. This way, you can create any necessary milestones or EDL items for ad hoc events, as well as planned events.

Note that your Vault may have the Apply Milestone Template entry action configured in addition to or instead of the user action. With this configuration, Vault automatically creates the appropriate records when a Study , Study Country , or Study Site enters a certain lifecycle state.

Milestones & Task Templates

Depending on your Vault’s configuration, Admins can define the creation of templated Clinical User Tasks associated with a Template Milestone Set .

When you create milestones from a Template Milestone Set , either as part of planned activities or an ad hoc event, Vault creates individual Clinical User Tasks from the associated Template Tasks , sets their due dates, category, requiredness, and task priority, and populates the Study , Study Country , and Study Site based on the context in which they were created. Vault relates the Clinical User Task to the appropriate Milestone , based on the Template Milestone selected on the Template Task record. Vault creates Clinical User Tasks as Study Tasks, Study Country Tasks, or Study Site Tasks, based on the level of the Template Milestone Set . Vault sends a notification about task creation, and the newly-created user tasks appear in the task assignee’s My Tasks tab. You can complete and work with these tasks as you would for any user task .

Note that your Vault may have the Apply Milestone Template entry action configured in addition to or instead of a user action. With this configuration, Vault automatically creates the appropriate Clinical User Task records when an associated Study , Study Country , or Study Site enters a certain lifecycle state.

About Milestone Autocompletion

An Admin can configure your milestones to autocomplete. When the Autocomplete field is set to All Dependencies or Any Dependencies , Vault moves the milestone to the Completed lifecycle state and populates the Actual Finish Date field once dependent milestones are complete, EDL items have matched, and required Clinical User Tasks are complete. Vault uses the most recent date on previous milestones, matched documents, and required tasks for the milestone’s Actual Finish Date .

Vault does not recalculate % Complete , or any of the metric fields on which it is based, on completed milestones.

Note : Vault automatically calculates completeness metrics and autocompletion after a five-minute delay to ensure that the calculations account for related activities.

Admins can also set up milestone autocompletion on your existing Milestone object records.

Automated Enrollment Milestones (CTMS)

An Admin can configure your CTMS Vault to automatically populate the Actual Finish Dates of first and last subject-related milestones based on the corresponding dates on Subject records at the site level and for a study arm or the study as a whole. For example, if the earliest Screened Date of the Subjects at a site is 10/27/2020, Vault automatically populates the Actual Finish Date of the First Subject Screened milestone for the site with 10/27/2020.

To utilize this feature, you must set the Metric Calculation field to Date-Based on the Study record. If the Metric Calculation field is set to Status Snapshot , Vault will not automatically populate the Actual Finish Dates of milestones for the study.

Note that subject-related milestones without study arms evaluate all subjects at the site, including subjects with study arms.

First Subject Milestones

The Actual Finish Dates of first-subject related milestones are populated as follows:

Last Subject Milestones

The Actual Finish Date fields on last subject-related milestones are populated when you set the No New Subjects checkbox for the Study Site record and all subjects at the site meet the milestone criteria. Clearing the No New Subjects checkbox on the Study Site record clears dates from all related Milestone records.

The Actual Finish Dates of last-subject related milestones are populated as follows:

No Subjects Enrolled

The No Subjects Enrolled field identifies any non-enrolling sites when you set the No New Subjects checkbox for the Study Site record. In your configuration, you can use this field to set a site’s milestones and determine which milestones dependencies to inactivate. This ensures proper roll-up of milestone dates. Clearing the No New Subjects checkbox on the Study Site record clears dates from all related Milestone records and sets No Subjects Enrolled to False/No .

How to Add Milestones to Documents

In order to use milestones, an Admin must first add the Milestone object document field to documents. When the Milestone document field is active and a Milestone object record exists, a user with Edit Document permission can update the field by choosing from existing milestones. An Admin can also configure a Vault to populate the Milestone field by EDL Item .

Viewing Expected Documents

You can view all Expected Document records associated with a Milestone record using EDL Hierarchical View .

About Milestone Types

The Milestone Type picklist field ( milestone_type__v ) is defined on the Milestone object ( milestone__v ) and as a document field. Vault allows an Admin to define custom milestone types based on the level of detail needed when tracking study startup or TMF completeness. Vaults using Study Startup and the associated milestone template set have milestones types pre-configured.

Your organization may expand milestone types to include higher levels of detail. This is common in large organizations who want to leverage milestone data coming from a CTMS or other project management source.

About Global Milestone Types

If you use Study Startup, your Admin can map standard milestone types and offset types to custom milestone types to enable Vault to automatically calculate cycle times for completed milestones.

Note : Note that your Admin must configure Global Milestone Mapping for Vault to calculate cycle times.

About Cycle Times

Vaults with Study Startup automatically calculate cycle times when an Admin has mapped Global Milestone Types to custom Milestone Types . Vault uses a system-managed job to calculate cycle times based on the actual offset times between milestones in your Vault. When active, the job calculates Cycle Times for milestones that meet one of the following conditions:

  • A new milestone record was created and has an Actual Finish Date
  • The Actual Finish Date field was populated or was modified since the job ran the day prior
  • Milestone Type
  • Study Country

The job applies existing Cycle Time records to milestones, creates new records if needed, and deletes records that no longer apply.

How Vault populates new Cycle Time records for Finish to Finish offset types:

About Milestone Object Types

If you use Study Startup, you may have default object types on the Milestone object. Milestone object types specify different fields and page layouts to differentiate types of milestones, like those related to submissions or study startup. You can select a Milestone object type when creating a new milestone record or by editing the Milestone Object Type field.

About Milestone Dependencies

Each Milestone Dependency object record represents pre-conditions for a Milestone ’s status. You can configure the order of milestones and the dependencies involved in milestone completion. When related to Milestone Dependency records, Milestone records can have many-to-many relationships . For example, one milestone may depend on the completion of three other milestones. Milestone dependencies follow the Study , Study Country , and Study Site hierarchy.

As of V16, milestone dependencies replaced “Up” and “Previous” milestone fields. ( “Up” and “Previous” fields are still available .)

Example: Protocol Approval & Study Greenlight

For example, for a study to enter the Protocol Approval milestone, the milestone Study Greenlight must be in Completed status. This can be ensured using a “Finish to Finish” milestone dependency. An Admin can enforce the order of milestones by using a lifecycle and entry criteria .

Example: Site Initiation

For example, a “rollup” type dependency can automatically fill the Actual Finish Date field on the Country First Site Initiated milestone with the earliest Actual Finish Date from all of the Site Initiated milestones associated with that Study Country . In this example, the Country First Site Initiated milestone has multiple Milestone Dependencies . These “rollup” type dependencies all use Country First Site Initiated as the Next Milestone field, and each Site Initiated milestone is the Previous Milestone for each dependency.

Milestone Dependency Types

A milestone dependency’s type determines how it functions:

Enabling Milestone Rollups introduces behavior for two (2) other milestone dependency types. You can also enable Milestone Rollup Enhancements, which adds additional checks and can provide more accurate rollup behavior in some scenarios.

Note : Your Vault may have customizations that modify the Standard Behavior listed here.

If needed, an Admin can configure additional milestone dependency types .

Note : When a milestone dependency involves updating any date values, the audit logs record it as a System Action. The action is not dependent on the permissions of the user changing the date values on the previous milestone.

How to Create a Milestone Dependency

You can create milestone dependencies individually or from milestone templates using the Create Milestones from Template action. If you created milestones individually, you must also configure milestone dependencies individually:

  • Open the Milestone Dependency object in Admin > Business Admin or in a custom tab.
  • Click Create .
  • Fill the required fields and relate the Milestone Dependency record to the correct Milestone records.
  • For Finish to Finish type dependencies, enter a number of days in the Date Offset field. This number of days (true days) represents the number of days Vault adds to dependent milestones with the Apply Updated Dependencies workflow step .
  • Click Save .

Updating Dependent Milestones

You can update Baseline and Planned dates of your milestone records, and then choose to have Vault propagate those changes to all downstream milestone records. Note that this is only available for milestones connected by Finish to Finish type milestone dependencies.

  • Update a Milestone record’s Baseline or Planned date.
  • Select the Apply updates to dependent milestones verdict to update dependent milestones.
  • Vault initiates the Apply Updated Dependencies system action to update your dependent milestones based on the Date Offset field. Vault also reevaluates all existing rollups affected by the date changes.
  • Vault sends a notification after updating all dependent milestones.

Choosing Dismiss closes the workflow task window and does not update any dependent milestones. Vault still saves your update to the Milestone record.

Set the Block Automatic Updates field to Yes to prevent the Update Dependencies workflow from updating the baseline and planned date fields on the next Milestone record. This setting supports top-down planning for the study.

Note : Vault cannot initiate the Update Dependencies workflow when a Milestone record is involved with a different object workflow. Wait until the active workflow ends before updating dependent milestones.

Milestone Hovercards

When you hover over a Milestone , Vault displays a hovercard for the record that allows you to quickly view a summary of the Milestone ’s completeness. This hovercard includes:

  • Milestone name
  • % Complete ; see details below for how Vault calculates this value
  • Status indicator icon, representing the milestone’s Completeness value
  • List of Milestone Dependencies with each record’s Completeness , Name , Planned Finish Date , and Actual Finish Date
  • List of expected documents with the number of Expected , Actual , and Approved documents related to the Milestone
  • List of matched documents with each document’s Name , Status , and Version
  • Counts of clinical user tasks, with the number of Total , Complete , Required , and Complete Required clinical user tasks

Click a document or object record link in the hovercard to navigate to that document or record detail page. If you click a View All link, Vault navigates you to a list view, for example, a list of all Milestone Dependencies .

Note that Milestone hovercards must be enabled by an Admin .

Milestone Completeness

Vault calculates the % Complete for a milestone by adding Completed Previous Milestones ( completed_previous_milestones__v ), Completed EDL Item Records ( completed_edl_item_records__v ) and Total Complete Required Tasks ( count_of_complete_required_tasks__v ), and dividing that total by the sum of Total Previous Milestones ( total_previous_milestones__v ), Total EDL Item Records ( total_edl_item_records__v ), and Total Required Tasks ( count_of_required_tasks__v ).

Vault takes these values from EDL Item object records. Note that the # Expected value of the EDL Item record is not considered when calculating completeness.

In the Completeness field, Vault references a milestone’s % Complete and displays the value as a status indicator icon. If a milestone has an Actual Finish Date , the % Complete displays 100%, even if your Vault allows a milestone to complete before all expected documents are approved.

Vault does not recalculate % Complete , or any of the metric fields on which it is based, on completed milestones. It will only recalculate those fields if the value in Actual Finish Date is removed.

Related Permissions

You can complete all steps in this article with the standard Business Admin, System Admin or Vault Owner profile.

If your Vault uses custom security profiles, your profile must grant the following permissions :

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The Best Tools and Resources for Productive Clinical Trial Monitoring Visits

If you work in Clinical Research, you know that there are different requirements for each type of Monitoring visit. Whether you are conducting a Pre-Study Visit (PSV), Site Initiation Visit (SIV), Interim Monitoring Visit (IMV)/Routine Monitoring Visit (RMV), or a Close-Out Visit (COV), each visit comes with its own set of nuances that the Clinical Research Associate (CRA) needs to be prepared for prior to traveling on-site or conducting the visit remotely. When a CRA’s visit goes well, the study can continue to move forward and stay on track for success.

When the goals of a Monitoring visit are not met, there is an increased risk that a Trial will be delayed and/or over budget or Patient Safety may be put at risk. Thankfully, there are ways to avoid unproductive Monitoring visits!

Monitoring Clinical Trials is one of the most important responsibilities for a CRA. With purposeful planning and organization, along with helpful Clinical Trial Monitoring tools and resources, CRAs can flourish in this role!

In this article, we focus on how a CRA can prepare for an Interim Monitoring Visit (IMV) but these tools and resources can be applied to all visits conducted either on-site or remotely by CRAs.

Typical CRA Responsibilities During an Interim Monitoring Visit

CRA responsibilities are based on the type of Visit being conducted. IMVs are the most common visit to occur during a Study’s lifecycle and usually happen every 4-6 weeks, depending on Site Enrollment. Here are the general tasks that CRAs address at an IMV or RMV:

  • Ensure Study eligibility by reviewing the Source documentation, medical records, and Case Report Form entries for all patients, especially those recently randomized. This includes the Informed Consent Form (ICF) collected at Screening, Randomization data, and Follow-up data, as well as Labs, ECGs, and vitals.
  • Perform a review of all reported Safety issues such as Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest.
  • Examine the Investigational Product (IP) and Study supplies.
  • Evaluate Study personnel to ensure all are appropriately delegated and trained to perform Study procedures.
  • Assess the Site facilities for any changes since the Pre-Study Visit.
  • Meet with the Principal Investigator (PI) and other Site staff to review the overall progress of the Study and the CRA’s findings. Provide re-training if needed and answer any questions the site may have.

  The Association of Clinical Research Professionals (ACRP) created this extensive checklist of tasks for a monitoring visit.

  During each visit, CRAs are responsible for documenting everything they observe and discuss. Following the visit, this information is compiled into a Clinical Monitoring Report. Here are 5 guidelines for writing an useful clinical monitoring report from MasterControl.

The Best Tools to Bring to a Monitoring Visit

The Clinical Research Monitoring tools that you bring have a meaningful impact on the success of a Monitoring visit.

Here are the three best Clinical Trial Monitoring tools to have at the Study site – or in your briefcase!

  • The Visit To Do List Pad makes planning your visit easier. Keep it with you while you are on site to help you stay focused and on task. If you’d prefer to skip the paper, the Visit To Do List is also available as a Digital Download!
  • Throughout your Monitoring visit, record Action Items on the Action Item Carbonless Pad . At the end of your Visit, leave one copy with the Site staff so that everyone is on the same page for the Action Items that need to be completed. Use the other copy to write your Monitoring Visit Report and Follow-up Letter. The Action Item Carbonless Pad is available for FREE for a limited time: https://clinessentials.com/clinical-trial-monitoring-tool/ . Download your copy today!
  • Last, take your Monitoring a step further with CRA Audit Notes that keep you organized – and give the site staff a visual indication of the tasks that must be accomplished. This simple upgrade from the yellow sticky notes typically used during monitoring help ensure your Action Items are addressed in record time. Along with being one of the best Site Monitoring tools, they also improve communication and effectiveness for Clinical Research teams!

If you are interested in a variety of the Monitoring tools listed above, check out the Bundles that allow you to purchase items at a discounted rate.

These Clinical Trial Monitoring tools alleviate high-stress, nonstop, jam-packed Site visits– making visits more productive, organized, and successful!

Steps for a Successful Monitoring Visit

Being prepared for a Monitoring visit is instrumental to the success of the Visit. When both the Clinical Research Associate and the Research Site are prepared, Monitoring visits run smoothly and efficiently.

With proper communication and a simple 5 step process , preparing for a Monitoring visit does not have to be overly time-consuming. Plus, spending time in advance will be time saved ensuring a productive, organized visit!

  • Plan the visit. Make sure that your plans are based on the Protocol or directions from the Clinical Research team (Clinical Trial Manager, Lead CRA and/or Sponsor).
  • Pack so that you are prepared . This free downloadable checklist gives our Top 5 Workbag Essentials and is a great way to simplify your packing and keep you organized.
  • Review the Study Protocol and have a thorough understanding of the entire document.
  • Highlight the Action Items. If you have questions or actions needing to be addressed during the visit, try to send them to the site in advance so they can be ready to address during your visit. It is always more effective to discuss and resolve questions or actions items while on site. Once you leave the site it may be challenging to get the site to make it a priority or you will have to review remotely.
  • Bring Clinical Trial Monitoring tools! (See The Best tools listed above!)

For more tips, check out this YouTube video about how CRAs should prepare for a routine monitoring visit.

Conclusion As a leader and essential member of the Research team, the Site staff will appreciate and respect you for your thoroughness and organization – and this makes for open communication and a better working relationship!

Introduce your Research teams to the time-saving tools that lead to successful monitoring visits. These same tools can also be used at the site level to keep the trial moving and on the right track in between Monitoring visits.

For more Clinical Trial Monitoring tools and resources that help Clinical Research Professionals become more efficient, visit www.clinessentials.com.

By: Tiffany Ashton MAS, CCRA, Director of Clinical Operations at ClinEssentials

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Site Preparation Checklist (Pre-Study Visit)

Download the Site Preparation Checklist for Pre-Study Visits (PDF) .

Carpathian Research Group: Your Solution in Clinical Trials

Introduction to the Monitoring in Clinical Trials, Pre-Study Site Selection Visit

  • Post published: 31.07.2023

pre study visit

As per Good Clinical Practice (GCP) guideline “the purposes of trial monitoring are to verify that:

  • a) The rights and well-being of human subjects are protected.
  • b) The reported trial data are accurate, complete, and verifiable from source documents.
  • c) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).”.

Clinical Trial monitoring is achieved via conducting the monitoring visits to Clinical Trial Sites (hereinafter referred to as “Sites”) either face-to-face or remotely.

The visits are performed by monitors (Clinical Research Associates, CRAs).

According to GCP guideline:

  • “a) Monitors should be appointed by the sponsor.
  • b) Monitors should be appropriately trained and should have the scientific and/or clinical knowledge needed to monitor the trial adequately. A monitor’s qualifications should be documented.
  • c) Monitors should be thoroughly familiar with the investigational product(s), the protocol, written informed consent form and any other written information to be provided to subjects, the sponsor’s SOPs, GCP, and the applicable regulatory requirement(s).”.

The Sponsor of each Clinical Trial is responsible to develop a systematic, prioritized, risk-based approach to monitoring Clinical Trials. The Sponsor may choose on-site monitoring, a combination of on-site and centralized monitoring, or, where justified, centralized monitoring. The Sponsor should document the rationale for the chosen monitoring strategy (e.g., in the monitoring plan).

Centralized monitoring is a remote evaluation of accumulating data, performed in a timely manner, supported by appropriately qualified and trained persons (e.g., data managers, biostatisticians). Centralized monitoring processes provide additional monitoring capabilities that can complement and reduce the extent and/or frequency of on-site monitoring and help distinguish between reliable data and potentially unreliable data.

This article aims to briefly introduce the monitoring, describe the types of monitoring visits of Sites in Clinical Trials, and focus on a Pre-Study Site Selection Visit as a starting point in the monitoring process.

Depending on the timeframe (phase) in which each particular Clinical Trial Project is the following visits types are identified:

  • Pre-Study Site Selection Visit (also known as Pre-Study Visit, Site Selection Visit, Site Qualification Visit)
  • Site Initiation Visit
  • Interim Monitoring Visit (also known as Routine Monitoring Visit)
  • Close-out Visit.

Additionally, Co-Monitoring Visit(s) may be performed with the aim of either supporting the CRAs in their visit activities or assessing Site’s/CRAs’ adherence to Clinical Trial Protocol, GCP and other clinical research regulations. Co-Monitoring Visits are out of scope of this article.

Monitoring visits have typically one business day in duration, but depending on Clinical Trial complexity, amount of data to be reviewed and other factors their duration can be increased.

The main written documentation of each monitoring visit (irrespectively of its type) includes:

  • Confirmation letter  – a letter/e-mail sent to Site well in advance of planned monitoring visit and which includes the details and activities to be done during the visit
  • Visit report  – detailed description of all activities performed during the visit as well as all identified deficiencies, deviations, and action item(s)
  • Follow-up letter  – a letter/e-mail sent to Site after the visit has been conducted and which includes the details of all activities performed during the visit as well as all identified deficiencies, deviations, and action item(s).

All confirmation, follow-up letters and Site Initiation Visit Report (per GCP requirements) are to be properly stored in Investigator Site File located at Sites.

Pre-Study Site Selection Visit (PSSV)

This is the starting point of interactions between Sponsor/CRO and Clinical Trial Site. It is performed after the Site Identification & Feasibility process has been completed.

The PSSV is performed to ensure that:

  • A potential Principal Investigator (PI) is qualified and interested in conducting the clinical study
  • The PI’s Site has adequate facilities, and resources to properly complete all required study activities
  • Site has required pool of patients to complete enrollment.

Items to be reviewed/discussed may include, but are not limited to:

  • Feasibility Questionnaire completed by Site
  • Clinical Study Protocol/Synopsis and Clinical Study timelines
  • Enrollment (recruitment) target, strategy, expectations, and availability of subject population
  • Qualifications/ training, experience, interest and availability of the PI and Site Staff performing study related duties
  • PI and Site Staff obligations, ICH-GCP / ISO 14155 guidelines (if applicable) and regulatory requirements
  • Therapeutic area being investigated (including applicable standard of care)
  • The PI’s/Site Staff’s regulatory inspection/audit experience, if any, and the outcome of the inspection/audit(s)
  • IRB/IEC requirements, documentation, and approval timelines
  • Site budget and execution of Clinical Trial Agreements
  • Informed Consent Process and documentation requirements
  • Source document and study record requirements, as well as Source Data definitions and Good Documentation Practice
  • Monitoring visit process/schedule, PI and Site Staff availability, other competitive clinical trials with the same pathology run by Site
  • The monitoring strategy including remote monitoring and remote Source Data Verification capacity and acceptance (if applicable)
  • Electronic Data Capture (EDC) requirements, including vendor-specific experience, internet connectivity, and computer availability, if applicable
  • Turn-around time for data entry and data query resolution
  • Local country / Site-specific requirements for clinical study conduct (e.g., Site SOPs)
  • Reporting and documenting safety events (e.g., Adverse Events, Serious Adverse Events, Adverse Events of Special Interest, SUSARs, pregnancy, study drug overdose etc.)
  • Medical management of study subjects remotely, if appropriate
  • Assessment of storage area and conditions for Investigational Medical Product (IMP) (includes Investigational Medical Device (IMD) and/or other study supplies/materials)
  • IMP/IMD Accountability procedures (receipt, storage, dispensing, and record keeping)
  • Laboratory sample handling procedures, including supplies, collection, and shipment.

During PSSV CRA ensures the adequacy of facilities where study subjects will be seen by visiting (touring) them (e.g., exam rooms for subject evaluation and treatment, laboratory and any special testing area, pharmacy (if applicable), any satellite sites (if applicable), working area for Site staff, data entry area etc.) CRA also ensures the adequacy of available equipment to be used in clinical study (including validity check for calibration/maintenance documentation).

As part of PSSV CRA requests/collects any required Site documentation which may include, but is not limited to:

  • Confidentiality (Non-Disclosure) Agreement, if applicable
  • Medical licenses (Institution and Site staff) and dated/signed Curriculum Vitae (CVs)
  • Current GCP and ISO 14155 (if applicable) training certificates or certificates of relevant training(s) as listed on the corresponding CVs
  • IRB/IEC membership list (roster), SOPs (if applicable) and statement of compliance
  • Electronic Health Records related documentation, if used
  • Completed dated/signed Project-specific forms and questionnaires required to qualify the Site, as applicable
  • Local laboratory reference ranges, accreditation certificates and CV of Head of local laboratory if it will be used
  • Dated/signed attendees log, Clinical Study Protocol, and Investigator Brochure acceptance pages.

The above documents may be collected as originals or copies, depending on Sponsor’s/country specific requirements.

On the basis of conducted PSSV and the review of all applicable documentation the Sponsor either approves Site’s participation in the given Clinical Trial or declines it.

If Site is approved CRA sends an appropriate Site Selection Letter and in case of disapproval – the appropriate Site Non-Selection Letter.

The above letters will thank PI and Site Staff for completion of Selection activities and will state the further actions to be completed (if Site is approved) or will explain the reason(s) for non-selection decision.

Carpathian Research Group capabilities

CRG as a CRO has extensive experience in conducting Pre-Study Site Selection Visits and choosing the most suitable Sites for successful Clinical Trial execution.

Information on all other Clinical Trial services that we provide could be found at  www.crg.global

You can contact us at  [email protected]

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Pre-Study Preparation

The key decisions involved with the pre-study preparation of industry-sponsored clinical trials include the following:

Confirm Research Support Services/Facilities

Based on your final budget and contract, contact the supporting departments who will be involved with the trial to let them know you are ready to begin. This might include:

ITHS CLINICAL RESEARCH CENTER

ITHS RESEARCH COORDINATION CENTER

INVESTIGATIONAL DRUG SERVICE PHARMACY Harborview Medical Center (206) 744-5448 | [email protected] UW Medical Center (206) 598-6054 | [email protected] Website

UWMC LABORATORY MEDICINE Administration (206) 598-6131 |  [email protected]

RESEARCH TESTING SERVICE (206) 616-8979 |  [email protected]

UW DEPARTMENT OF PATHOLOGY NWBioSpecimen

UW DEPARTMENT OF RADIOLOGY RESEARCH PROGRAM

Site Initiation Visit

Many industry sponsors/Clinical Research Organizations conduct a Site Initiation Visit (SIV) to prepare and set up a research site, conduct protocol training, and ensure the Principal Investigator (PI) fully understands all trial responsibilities.  The visit usually occurs after the site has completed all regulatory requirements, including Institutional Review Board approval, but prior to recruiting participants.  The sponsor/Clinical Research Organization will want to meet with the PI and as many members of the research team as possible.  The sponsor/Clinical Research Organization may ask to meet with representatives from supporting departments (e.g., pharmacy, radiology, lab medicine).

Topics of discussion during the site initiation visit include:

  • PI responsibilities
  • PI and research team qualifications
  • Study objectives, eligibility criteria, recruitment, and procedures
  • Space requirements, availability of a secure area to store investigational drug or devices, availability of required equipment
  • Lab manual, specimen processing, and shipping
  • Regulations and Good Clinical Practice (GCP) guidelines, informed consent requirements, Institutional Review Board obligations, adverse event reporting, drug accountability, source documentation, and records retention (regulatory documents and study file organization)
  • Data forms review (Case Report Forms, or CRFs), including electronic data entry

If it is a large multi-site trial, a sponsor/Clinical Research Organization may choose to hold an Investigator Meeting in lieu of conducting site initiation visits.  In this case, the meeting is held sometime after the Site Qualification Visit (link to Site Qualification Visit ) and prior to recruiting participants. The Investigator Meeting is usually only attended by the PI.  However, if the PI is unable to attend, the sponsor/Clinical Research Organization may allow a co-investigator or research coordinator to attend.  Travel to this meeting is coordinated and paid for by the sponsor/Clinical Research Organization.

Access to UW Electronic Medical Records

To use the University of Washington’s electronic medical record systems (ORCA and Epic) to identify eligible patients or capture clinical data about participants, you will need to request ORCA and Epic access for necessary research staff from User Access Administration .

If you have questions about ORCA access privileges or how to complete the form, contact: [email protected] .

If you access PHI for research purposes under an Institutional Review Board-approved HIPAA waiver, you must record and submit records of the dates and purposes of these disclosures to UW Medicine Compliance via the UW Medicine Disclosure Accounting online database.

UW MEDICINE COMPLIANCE (206) 543-3098 | [email protected] Accounting of Disclosures Use & Disclosure of Protected Health Information for Research Accounting of Disclosures of Protected Health Information

Pre-Screening to Identify Participants

To identify possible subjects for research, you may need to access Epic or ORCA to look at healthcare records. Even if you are involved in the clinical care of the possible subjects, you will need Institutional Review Board approval of a Waiver of HIPAA Authorization (and if the UW is the Institutional Review Board reviewing the project, a Waiver of Informed Consent and Confidentiality Agreement as well).

Members of your research team may need to complete Epic Training, which is described in the “Training/Credentialing” section below.

Clinical Research Billing for Research Procedures

There are complex federal and private payer rules that govern the conditions under which clinical services, items and tests associated with a research study can be billed to study sponsors, study subjects and/or their insurers. Research teams are required to use Epic to accurately bill for research procedures. Accurate research billing depends on planning and collaboration between the research team and a wide variety of individuals and offices before, during and after the study is initiated.

EPIC REVENUE CYCLE OPERATIONS EDUCATION [email protected] Research Billing Compliance Policies Research Participant Association in Epic Epic Billing Tools

Laboratory Medicine and Research Testing Services

If results of testing performed by University of Washington Lab Medicine will be part of data capture, you must maintain copies of lab normal ranges along with CLIA and CAP certifications.

Licenses & Accreditation

Lab Medicine is also the home department for Research Testing Services, which coordinates and provides research-related phlebotomy, CLIA-licensed testing, research-only testing, processing, and limited specimen storage.

UW LABORATORY MEDICINE Research Testing Service (206) 616‑8979 |  [email protected]

Research Instrument Validation and Calibration

Scientific Instruments supports more than 18,000 pieces of patient care, laboratory, and research equipment spread across the greater Seattle area including UW Medical Center, Harborview Medical Center, Northwest Hospital & Medical Center, Seattle Cancer Care Alliance, UW Physician’s Neighborhood Clinics and a variety of other University, state, federal and other publicly funded agencies.  Their records can be used to document compliance with TJC, CAP, CLEA, AABB, Food and Drug Administration, CMS, or other accrediting agencies’ requirements for equipment maintenance.

UW HEALTH SCIENCES SCIENTIFIC INSTRUMENTS Machine Shop (206) 616-5074 |  [email protected]

Arranging Compensation for Research Participants

Trials often offer compensation to research participants to encourage and appreciate the time and effort involved in participation.  Payments or travel/parking reimbursements to research subjects must be approved by the IRB as part of the research activities.  You may need to work with your department to identify specific procedures for compensation of research participants.

UW HUMAN SUBJECTS DIVISION (206) 543-0098 |  [email protected]

UW PROCUREMENT SERVICES (206) 543-4500 |  [email protected]

UW TRANSPORTATION SERVICES 206-221-3701 | [email protected]

Register Study on Participate in Research

Researchers can post their trials to www.ParticipateInResearch.org , and potential volunteers can search for studies that apply to them. This website was developed by the Institute of Translational Health Sciences in partnership with the UW School of Medicine’s Office of Research and Graduate Education to connect research teams with members of the community.

Set Up the Study Binder

Regulatory binders help research teams organize their files, maintain regulatory compliance, and adhere to Good Clinical Practice (GCP) standards for record keeping practices for research involving human subjects. Most sponsors/Clinical Research Organizations will provide the organizational forms and supplies they require you to maintain throughout the trial.

Helpful background can be found in Section 8, “Essential Documents for the Conduct of a Clinical Trial,” of the Food and Drug Administration’s guidance document E6, Good Clinical Practice: Consolidated Guidance.

Do a Walk Through

To make sure you are prepared to conduct the trial, do a walk-through of the research procedures before you schedule the first visit:

  • Confirm pre-screening steps in Epic and ORCA
  • Create visit packets that contain your recruitment, consent, and data collection resources you will use when approaching participants
  • Role play a recruitment conversation using the recruitment script
  • Pretend to schedule a study visit
  • Role play an informed consent discussion
  • Walk from the place where you’ll meet the participant to the visit location(s)
  • Make sure you have everything you need at the visit location(s):  lab kits, MD orders, pharmacy communication, lab requisition slips, data collection forms, laptop to access eCRFs/regulatory docs, equipment calibrated and in working order, mailing/shipping containers
  • Review data collection forms (CRFs) and confirm access to electronic data entry system

Training/Credentialing

Human subjects protections training.

There is no institutional-wide requirement for human subjects training at the University of Washington. However, many sponsors, funding agencies, UW departments, and collaborating institutions require that all members of the research team have completed a standard training course on the protecting human subjects in research.  The Collaborative Institutional Training Initiative (CITI) web-based training meets the requirements of most industry sponsors.  To take a course on the CITI website, you must register for an account and then affiliate yourself with the UW.

UW HUMAN SUBJECTS DIVISION TRAINING (206) 543-0098 |  [email protected] Human Subjects Division website

Clinical Trial Policy Training

University of Washington’s Clinical Research Budget & Billing (CRBB) support office provides Clinical Trial Policy Training to ensure that all UW Medicine faculty have a uniform knowledge of the regulations governing clinical research and that they understand the internal processes that have been implemented in order to maintain compliance in clinical research billing.

Your research support staff may also need to complete the CRBB modules within the UW Medicine Clinical Research Staff Training Program (CRB1, CRB2, CRB3) .

HIPAA Training

UW employees who are involved with research conducted with UW Medicine facilities must complete “HIPAA Online Training” and sign the “UW Medicine Privacy, Confidentiality and Information Security Agreement” within the first 30 days of the individual’s first day as a member of the research team.

UW MEDICINE COMPLIANCE  (206) 543-3098 |  [email protected] HIPAA Privacy and Information Security Training

Epic Training

For trials that utilize UW Medicine clinical facilities, investigators (or their designees) are required to use Epic scheduling software to enter research subject enrollment status information and to forward study-related admission notifications to the UW Clinical Research Budget and Billing office. To do this work, members of the research team need to complete Epic training and obtain access to Epic.

Register for the Epic classroom training course, RES110: Epic Research Participant Enrollment.

EPIC REVENUE CYCLE OPERATIONS EDUCATION [email protected] UW Medicine Account Activation Request Form

Bloodborne Pathogens Training

Principal investigators are responsible for assessing research activities to determine if members of the research team have a potential for exposure to human blood and its components, human tissue, all human cell lines, human source materials, as well as medications derived from blood (e.g., immune globulins, albumin) and other potentially infectious materials. If your research activities involve human blood and its components, you and your research team are required to comply with the UW’s Bloodborne Pathogens Program, which includes a training requirement.

UW ENVIRONMENTAL HEALTH AND SAFETY Training Administration (206) 543-7201 |  [email protected] Bloodborne Pathogens Program

Radiation Safety Training

Members of your research team may need to complete radiation safety training or review “Radiation Safety Training for Ancillary Personnel.”

UW ENVIRONMENTAL HEALTH AND SAFETY Training Administration (206) 543-7201 |  [email protected] Radiation Safety Training for Ancillary Personnel Radiation Safety Training

Shipping Biohazards Certification

If your research team will package and ship specimens via land, air, or sea, all team members must be trained and certified to ship hazardous materials. There are prescriptive requirements for packaging and labeling of hazardous materials and for the associated documentation used in the event of an emergency. There are fines for lack of certification and improper packaging and, worse, a chance for loss of life and property.

UW ENVIRONMENTAL HEALTH AND SAFETY Training Administration (206) 543-7201 |  [email protected] Shipping Hazardous Materials

UW Medical Center Credentialing

The UW Medical Center credentialing process ensures that individuals other than physicians, Nurse Practitioners, and Physician’s Assistants who interact with patients at UW Medical Center are competent to practice in their role and have current immunizations to ensure the safety of the patients. Members of your research team interacting with UW Medical Center patients must have current credentialing.

UW MEDICAL CENTER CREDENTIALING [email protected] Credentialing

Clinical Researcher

CRA Soft Skills for Pre-Study Evaluation Visits

Clinical Researcher June 20, 2023

pre study visit

Clinical Researcher—June 2023 (Volume 37, Issue 3)

Elizabeth Weeks-Rowe, LVN, CCRA

The pre-study evaluation visit is far more than a clinical research associate (CRA) confirming an investigational site’s facilities, equipment, and personnel for potential study participation. The pre-study evaluation visit is the impetus for relationship development/sustainability with the investigational site, and if conducted appropriately, builds the framework for the collaborative relationship integral to study conduct. The CRA is an extension of the study sponsor, and his or her behavior bears the weight of this representation. The CRA must therefore cultivate a positive impression at the beginning of the evaluation visit process; the resulting outcome will influence site selection, site willingness to participate, and future endeavors. It must be navigated carefully.

Making the First Impression Count

First impressions are multifaceted, fluid; they lay the groundwork for a growing, more mature impression that builds to the current impression and onward to a lasting impression, whether positive or negative. A successful impression is borne of professionalism, supported by preparation, and should be framed with positivity for the outcome desired.

There are specific behaviors, when demonstrated by the CRA during the pre-study evaluation visit, which will elevate visit conduct and ensure a positive impression with the investigational site. For example, the CRA should:

  • Be flexible when scheduling the pre-study evaluation visit with the site. The CRA is scheduling for one, whereas the site representative is scheduling for multiple participants/departments and has less flexibility. Successful accommodation requires compromise.
  • E-mail the study coordinator a list of questions to be asked ahead of the visit. This helps the site to better prepare for the visit, and the CRA may even receive answers to some questions before the visit. This facilitates effective time management and support for all participants.
  • Provide an agenda that delineates activities, required attendees, and timeframe. This provides the site with the parameters to organize personnel and logistics effectively.
  • Provide the principal investigator (PI) and site personnel with the protocol, slides, and all documents to be reviewed/completed in advance of the visit.
  • Obtain the correct address and directions to the investigational site from the study coordinator/site representative, instead of relying on an address in a database that may be incorrect.
  • Print a copy of the slides and protocol to bring to the visit and provide for any attendees who want to write notes during the presentation. Obviously, the site can print copies, but this is sometimes forgotten in the rush to organize things. It is helpful to a site if the CRA does this. Alternatively, if there is an equipment or internet failure, printed copies ensure the visit can proceed when there is no other option for review of information.
  • Bring the schedule of assessments from the protocol to the visit, as it provides a large-scale view of protocol activities and helps the site further consider its capabilities (visit frequency, patient burden, timing, resources).
  • Arrive at the site 15 to 20 minutes before the visit. Punctuality demonstrates respect for others’ time and the CRA’s efficiency, and gives the CRA extra time to set up.
  • Be very familiar with presentation content and mindful of presentation timing, due to unanticipated or unavoidable schedule changes by site staff. At the pre-study evaluation visit, the CRA should confirm how long the PI is available in person and adapt accordingly. For example, if the PI’s availability changes from 60 minutes to 20 minutes, the CRA can pivot and only review the most critical required information to fulfill visit requirements.

Other Courtesies and Considerations

If the PI is unexpectedly not able to attend the pre-study evaluation visit, the CRA should not automatically reschedule the visit. The CRA may be able to schedule a teleconference with the PI to review protocol and required information soon after the pre-study evaluation visit, while still completing the onsite evaluation visit with the remaining site members. This will prevent revenue loss associated with changing travel and schedules. The CRA must obtain permission from study management to follow the aforementioned process.

During the protocol presentation, the CRA should stick to the critical points and let the bullet points guide discussions and supplement attendees with information. It is not necessary to review every bullet point and every slide in the presentation, and the audience will appreciate this effort.

The CRA should be professional, respectful, and kind to site staff. They are graciously allowing an “outsider” into their facility and committing a large amount of time for study consideration.

The CRA should be clear on the questions to ask and the information to present. Lack of preparation will hinder what should be an efficient and equitable process.

The CRA should understand that the pre-study visit is a reciprocal consideration. The site personnel are assessing the CRA as much as the CRA is assessing them. If the CRA is informative, patient, and positive, it will result in transparent and professional dialogue that illuminates and engages all players.

The CRA should give positive feedback. If the study coordinator was responsive and fulfilled all advance requests to organize the visit effectively, make sure to thank the study coordinator and inform the PI of the study coordinator’s effort. If the PI was generous with his/her time, thank them sincerely; the investigator’s time is very limited and this investment shows their high regard for the study/contract research organization/sponsor.

Hardworking site personnel deserve recognition and respect, for they are in the proverbial trenches executing study activities and preserving the tenets of patient safety and credible data that are the framework for the clinical trials we conduct.

pre study visit

Elizabeth Weeks-Rowe, LVN, CCRA, ( [email protected] ) is an independent research consultant and former clinical research coordinator with a track record of expertise in site selection and education for the contract research organization industry. She last wrote for Clinical Researcher in October 2022 (“ Lessons from Female Innovators in Clinical Research ”).

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First Study Visit Success

Over the past few months, we have sought to provide retina specialists and their staff members with an understanding of the world of retina clinical research, the siteselection process, and basic but effective strategies for recruiting subjects. In this month’s column, we will provide an outline of simple steps that can be taken to ensure that your first study visit is a success.

Pre-Study Logistics

With a thorough understanding of the study’s protocol under your belt and quick-reference guides prepared, one must not lose sight of the importance of pre-study visit logistics. Simple precautions can be taken to avert troublesome situations. Ensure that all equipment, particularly imaging systems, is in working order prior to a study visit. Conducting a pre-study meeting or walking through a patient’s visit is crucial to troubleshoot study flow challenges. Placing reminder telephone calls to patients a few days in advance of their study visit is also advised. In doing so, you not only help to build a rapport with your patients, but also learn of any late-breaking scheduling or transportation issues that the patient may raise during your discussion. If the patient’s transportation to and from the study visit appears to be problematic, your office staff may be able to arrange transportation on the patient’s behalf. Study sponsors may be willing to provide for patient travel cost reimbursement if this provision has been approved by your site’s governing institutional review board (IRB). Thus, taking even simple steps, such as proactively checking your site’s equipment and ensuring that patients will come in at their scheduled times, can contribute to a smooth and successful study visit.

Proper Preparation

Once you are comfortable with the protocol’s structure and contents, it is advisable to place study quickreference guides in your research space. These tools usually distill most of the critical elements of the study’s design into compact, laminated manuals. If your study’s sponsor or clinical research organization (CRO) has not provided you with guides, we recommend that your staff create them de novo; these accessories will not only be valuable in answering common study-related questions, but your site’s creation of its own set of study-specific reference tools shows initiative and attention to detail to sponsor or CRO representatives. Quick-reference guides commonly include lists of key inclusion and exclusion criteria, schedules of procedures for each study visit, visual acuity requirements, and study-specific instructions for ophthalmic photographers to ensure that imaging data is collected per protocol. Having a set of well-designed and accurate quick-reference tools will likely pay dividends on busy clinic days, when consulting a dense clinical protocol for answers to basic questions may be too time-consuming.

First Patient First Visit

As is the case with most aspects of running a busy clinical practice, proper preparation in advance of a study patient’s first visit is critical to the visit’s success. If you are unfamiliar with clinical research, this event might seem daunting at first. However, even if you and your staff members are experienced clinical researchers, making adequate preparations for your site’s first patient first visit (FPFV) in a new study will help your team approach this milestone with confidence. Creating and maintaining a checklist of the items discussed within this column to help track your site’s preparations for your FPFV is one way to assure that all necessary tasks have been fulfilled. Although you and your study coordination staff should have previously reviewed the study’s protocol, we recommend thoroughly rereading the document to gain a deeper understanding of exactly what will be required of you, your staff, and your patient at Visit 1.

With the pearls that we have provided in hand and the suggestions of your peers to guide you, your FPFV will hopefully prove to be problem free. Your preparations will undoubtedly prove to be valuable and, with your first study visit behind you, you will have the confidence and experience to tackle future study visits with finesse. Remember, however, that once your first study patient has left your clinic for the day, your job is not yet complete. Promptly transcribe source data into the study’s electronic case report forms (eCRFs) and address any automated edit checks that may appear; rapid and accurate data entry following a study visit is critical, as these CRFs are the physical records of your findings. Once these data have been successfully entered into the eCRF, it is worthwhile to schedule a time to speak with your staff and debrief. You will want to collectively assess what worked or did not work during the study visit and come up with solutions to problems that were encountered.

dence and experience to tackle future study visits with finesse. Remember, however, that once your first study patient has left your clinic for the day, your job is not yet complete. Promptly transcribe source data into the study’s electronic case report forms (eCRFs) and address any automated edit checks that may appear; rapid and accurate data entry following a study visit is critical, as these CRFs are the physical records of your findings. Once these data have been successfully entered into the eCRF, it is worthwhile to schedule a time to speak with your staff and debrief. You will want to collectively assess what worked or did not work during the study visit and come up with solutions to problems that were encountered.

Pat yourself and your staff on the back for a FPFV job well done. With the lessons learned from this experience, preparation and execution of future study visits should come as second nature. In next month’s column, we will discuss proper documentation practices in a clinical research setting.

Gail L. Torkildsen, MD, is in private practice at Andover Eye Associates in Andover, MA. David Waters-Honcu is a Manager of Retina Clinical Operations at Ora, Inc. Ashley Lafond is a medical writer at Ora, Inc.

Key Considerations

Prior to the study visit:

  • Make a checklist of important steps throughout the day.
  • Review the protocol.
  • Create and/or review study quick-reference guides.
  • Ensure that all study-related equipment is functioning properly.
  • Place reminder calls to subjects.
  • Have subject contact numbers and names of CRO or sponsor handy for questions.

During the visit:

  • Complete all source documents accurately and thoroughly.
  • Call your CRO or sponsor with any questions. They are there to support you!

After the visit:

  • Assess what worked and what did not work. Are there parts of the visit that could have gone more smoothly?
  • Transcribe source data into case report forms.
  • Follow-up with subjects, if necessary.
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Pre-Study Visit

A pre-study visit is a site evaluation that is conducted prior to the initiation of a clinical trial. It is typically performed by a representative from the sponsor or the CRO and is designed to assess the site’s readiness and capability to conduct the study. The purpose of the this visit is to ensure that the site meets the regulatory and ethical requirements for conducting clinical trials and that the site is capable of conducting the study in a manner that is consistent with the protocol and good clinical practices (GCP).

During the pre-study visit, the following activities are typically performed:

  • Review of regulatory documentation: The visit team will review the site’s regulatory documentation, including the institutional review board (IRB) or ethics committee (EC) approval and informed consent documents.
  • Site facilities and equipment: The visit team will evaluate the site’s facilities, equipment, and supplies to ensure that they are suitable for conducting the study and that they meet the necessary regulatory requirements.
  • Study personnel: The visit team will meet with the study personnel, including the principal investigator, study coordinators, and other staff, to discuss their roles and responsibilities and to assess their training and competence.
  • Patient recruitment: The visit team will discuss the site’s plans for patient recruitment and enrollment, including the methods that will be used to identify and screen potential participants.
  • Data management: The pre-study visit team will review the site’s data management processes and systems to ensure that they are suitable for collecting, storing, and reporting the trial data.
  • Study conduct: The pre-study visit team will review the study protocol and procedures to ensure that the site is capable of conducting the study in a manner that is consistent with the protocol and GCP.

The pre-study visit is an important step in the clinical trial process and helps to ensure that the study is conducted in a manner that is compliant with the regulatory and ethical requirements and that the results of the study are reliable and of high quality.

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Mastering Pre-Study Site Selection Visit

Mastering Pre-Study Site Selection Visits in Clinical Research (PreStudyCRMaster)

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Course Description

The Mastering Pre-Study Site Selection Visits in Clinical Research program is designed to provide clinical research professionals with the knowledge and skills needed to effectively plan, conduct, and follow up on pre-study site selection visits. Participants will gain an understanding of the critical role these visits play in ensuring successful trial initiation and adherence to regulatory standards. Below is an outline of the course: - Importance of Pre-Study Site Selection Visits. - Understanding the purpose and objectives of pre-study visits. - Regulatory guidelines and ethical considerations. - Link between effective site selection and trial success. - Ensuring patient safety and data integrity during site selection. - Preparation for Pre-Study Site Selection Visits. - Developing a pre-study visit plan and checklist. - Identifying key site personnel to interact with. - Assessing site capabilities and infrastructure. - Ensuring completeness of site-specific documents. - Conducting Effective Pre-Study Site Visits. - Communicating with site personnel prior to the visit. - Conducting interviews and assessments during the visit. - Addressing potential challenges and concerns. - Evaluating site readiness and commitment. - Documentation and Reporting. - Documentation of pre-study visit findings and observations. - Follow-Up and Decision Making. - Preparing site-specific pre-study visit reports. - Regulatory submissions and documentation requirements. - Ensuring consistency and accuracy in reporting. - Interactive Workshop: Simulated Pre-Study Visits. Analyzing realistic pre-study visit scenarios. Group discussions on challenges and best practices. - Hands-on exercises: conducting mock pre-study visits. - Role-playing activities: simulating site interactions and assessments. - Follow-Up and Decision Making. - Reviewing pre-study visit findings with the study team. - Making informed decisions on site selection and readiness. - Addressing outstanding queries and concerns. - Ethical considerations and patient data privacy during site selection. - Active participation in group discussions and interactive sessions. Hands-on exercises and role-playing evaluations. Practical application of pre-study visit planning and conduct.

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  • v.10(2); 2021 Jun

Monitoring in clinical trials of complementary and alternative medicine

So-young jung.

a Clinical Research Division, Korea Institute of Oriental Medicine, Daejeon, South Korea

Jung Won Kang

b Department of Acupuncture & Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul, South Korea

Tae-Hun Kim

c Korean Medicine Clinical Trial Center, Korean Medicine Hospital, Kyung Hee University, Seoul, South Korea

Associated Data

There is no available data as this work used available literature.

Clinical trial monitoring is an essential activity for quality assurance (QA) to ensure the protection of human rights and the reliability and transparency of the data collection process. The purpose of this article is to enhance the understanding of monitoring process and major findings in clinical trials of complementary and alternative medicine (CAM).

Based on International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use (ICH-GCP), we summarized main concept of monitoring process. Personal experiences on monitoring for CAM studies were also narratively described.

In this brief article, the basic concept of QA and quality control (QC), various monitoring activities during the study process, and major findings regarding clinical trials of CAM are suggested in an effort to improve understanding of monitoring in clinical research on CAM.

When performing clinical trials for CAM-related interventions, the monitoring recommended in GCP is needed to be recognized as a mandatory element in the course of CAM research.

Introduction

"Safeguarding the health of the people" is the primary mission of the medical profession. 1 In line with this proposition, clinical research should be designed and implemented ethically and scientifically. Clinical trials in humans are inevitable in new drug or medical device development to ensure the efficacy and safety of the intervention. However, protection of human rights is paramount.

Clinical research relies on the dedication of participants who willingly take expected or unexpected risks. The principal aim of a clinical trial should be the contribution that can be made to human health and well-being by expansion of medical knowledge. Therefore, the results of clinical trials should be transparent and reliable.

Monitoring in the context of a clinical trial entails many types of systematic activity to ensure that the study is conducted and data are acquired according to the planned protocol in compliance with Good Clinical Practice (GCP) and relevant legislation. 2 The reliability of the data collected cannot be ensured by the investigators' efforts alone and is only possible through systematic planned supervision of research procedures. From this point of view, monitoring has come to be recognized as an important procedure in clinical research. 3

The research purpose and strategy in clinical studies involving complementary and alternative medicine (CAM) are different from those in trials of pharmacological interventions conducted for the purpose of gaining regulatory approval to market a new drug entity. The majority of CAM interventions have long been used without supporting evidence from clinical trials, and most researches have been focused mainly on establishing the safety of CAM and its effectiveness relative to conventional treatments in an effort to establish clinical evidence for CAM interventions. 4 Protection of human rights, overseeing the research steps in the study plan, and confirming the accuracy of the data collected are also essential in clinical trials of CAM. The purpose of this brief review is to enhance the understanding of researchers about monitoring process in general and major considerations of CAM trials.

Basic concepts of quality assurance and quality control in clinical trials

A clinical trial should be conducted based on a predefined study protocol, and the data generated need to be documented accurately. Furthermore, the trial data must be analyzed and reported according to the study plan. Of particular importance is that the ethical conduct of the study should be in compliance with relevant regulations. Quality assurance (QA) is defined as any type of planned systematic activity intended to ensure transparency in the conduct of clinical trials, reliability of study data, and protection of human rights.

While QA is a comprehensive principle, quality control (QC) refers to specific operational techniques and activities that ensure the quality of research. 2 The quality of clinical trials reflects multidimensional factors that range from the design of the study to reporting of the results, whereas QC and QA directly reflect how rigorously the study was conducted according to the research protocol and accurate collection of research data. 5 Ensuring the quality of clinical trials is important, given that when pharmaceutical and medical device companies develop a new chemical entity or device, they cannot conduct the necessary clinical trials themselves. Instead, they must take a sponsorship role and rely on hospital-based investigators who are responsible for clinical practice and day-to-day conduct of a clinical trial. Therefore, it is necessary to have a detailed study plan and a strategy for determining whether or not the study is being conducted correctly. QA and QC are needed to ensure that a clinical trial is performed in accordance with the established protocol, standard operating procedures (SOPs), GCP, and relevant regulations set out by the sponsor. 2 Using a strict monitoring procedure, the sponsor can evaluate the overall status of research under way at a participating institution and address any problems identified in monitoring reports so that the study is well conducted. Thus, monitoring is essential to guarantee internal validity of clinical trials. 2

Procedures and methods used for trial monitoring

According to the International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use (ICH-GCP), on-site monitoring is recommended before, during, and after the trial procedure, whereas central monitoring is advised only in exceptional circumstances, which often leads to misunderstandings regarding whether or not on-site monitoring is mandatory and has priority for all cases. 6 However, there is evidence suggesting that intensive on-site monitoring is not always effective in identifying errors and has a significant cost burden. 3 In response, the current ICH-GCP version (R2) has added the potential benefit and role of central monitoring to its addendum section. 7 The 2020 COVID-19 pandemic has rendered regular on-site monitoring impossible at present, and reliance on central monitoring is increasing. However, there are still some logistical inadequacies that make it difficult to rely on central monitoring alone. Central monitoring must include the ability to identify adverse reactions in research participants, but it is impossible to obtain the relevant data without visiting the study site. Therefore, a better QC strategy is needed to resolve the significant challenges of data monitoring in the current climate.

Sponsors need to have SOPs for clinical trials that include detailed procedures and designated personnel to perform the necessary monitoring activities. GCP states that sponsors need to decide the nature and extent of monitoring based on the specific features of the study, such as objectives, design, complexity, and size. 2 Sponsors may directly employ full-time monitors or appoint a contract research organization to perform monitoring activities on their behalf. The monitors should be trained and have appropriate knowledge on the investigational product, study protocol, how to complete informed consent forms, the sponsor’s SOP, and regulatory requirements, including GCP and the relevant legislation.

Monitors should be appropriately qualified in accordance with GCP 2 and usually have an academic degree in a health-related discipline such as nursing. The main roles of a monitor are defined by GCP, and are classified according to the principal purpose of monitoring as follows: first, they must ensure protection of human rights during the trial by checking that all study participants have provided written informed consent; second, they must ensure that the data collected are accurate and complete by checking the source documents; and third, they must confirm whether or not the study is conducted according to the protocol, SOP, GCP, and other regulatory requirements by verifying the qualifications of investigators, checking the status of investigational products and performance of research personnel, and confirming the management status of trial documents. Another important role is to provide a channel of communication between sponsors and investigators. Monitors need to check whether the investigators are receiving appropriate information about the trial and all necessary supplies from the sponsors. They also need to be able to report the recruitment status of the trial at any time point and the results of their monitoring activities to the sponsor. 2

Monitoring activity

On-site monitoring is classified according to the status of a clinical trial ( Fig. 1 ). The pre-study site visit recommended by GCP is not mandatory for monitoring. Sponsors identify the most appropriate research center for conducting a clinical trial and send a trained representative who is either employed directly by the sponsor or a clinical research associate affiliated to a contract research organization that performs trial-related duties and provides expertise as part of their contract with the sponsor. 2

Fig. 1

On-site monitoring in the different stages of a clinical trial.

During the pre-study site visit, the research capability of the site is assessed considering the adequacy of facilities, recruiting ability, and the expertise of the investigator (s). After the study protocol is approved by the institutional review board and local regulatory agency (if necessary) and the investigational products are ready for delivery, a site initiation visit is made to train the research team and prepare the necessary documents and equipment needed at the institution.

The site initiation visit is the last opportunity to check that all study-related issues have been addressed and that preparation is complete before recruitment starts. Essential documents for evaluation of trial conduct and the quality of the study data according to ICH-GCP 2 need to be updated and kept secure in the research institution and sponsor site in a timely manner. The clinical research associate usually prepares packages including informed consent forms, investigator site files, and worksheets for distribution at the site initiation visit.

Monitoring visits, which are the most important activity in terms of the QA and QC of a clinical trial, start after the first participant is recruited and end when the final subject has been evaluated. Source document verification (SDV), which is not clearly referred to in ICH-GCP, is a systematic process for identifying the completeness, accuracy, and validity of data collected for each study participant and requires comparison between the source data and the case report form (CRF). 8 Source data include all types of information in the original or certified copies of original records obtained during clinical trials. They are contained in the source documents, which are medical charts, laboratory reports, or work sheets, including instruments or tools for patient-reported outcomes. 2

A CRF is specially prepared for each participant in a clinical trial and records all information that will be used for the analysis. 2 An SDV is necessary to confirm that the data collected in the CRF are accurate and reliable and that none have been incorrectly entered or omitted because of transcription errors. It is not always possible to review every single item of study data during the SDV, and there is no clear evidence that an SDV significantly improves the integrity of the data. Therefore, partial on-site SDVs combined with centralized, risk-based monitoring are considered acceptable. 9 When using this approach, monitors usually categorize data into critical (e.g., related to informed consent, evaluation for selection of participants, and adverse events) or noncritical. Critical data are monitored in all study participants, whereas noncritical data are checked in only a small sample (for example, 25%) of CRFs at a monitoring visit. 8

The entire monitoring process needs to be documented, and monitoring reports must be submitted to the sponsors. 2 A close-out visit is conducted generally after the last follow-up visit for the final study subject. All queries that arise during the SDV need to be resolved, and all documents related to the clinical trials should be checked at this visit. Any documents that are missing in the investigator site file or trial master file should be tracked and included at this visit. Finally, the clinical research associate must return any unused study equipment and investigational drugs or medical devices to the sponsor.

Common findings in clinical trials in complementary and alternative medicine

When CAM research is monitored by an experienced clinical research associate (CRA), there is little difference in the major findings in clinical trials between biomedicine and CAM. Problems that arise during monitoring often stem from misunderstanding of the clinical trial protocol and procedures on the part of the researchers themselves. Even for CRAs and coordinators, the most difficult part of the job is to understand and answer questions about study protocols and procedures. 10 In this sense, findings of protocol deviation or trial misconducts are common in CAM trials. Based on the empirical evidence, minor findings such as deviations of window visit are the most frequent findings which can be observed in most of the CAM studies. Although important items, such as correct application of inclusion and exclusion criteria are thoroughly checked, important examination and laboratory data requested as part of the study protocol are missing sometimes. Omissions of laboratory tests and violations of random allocation are very rare but are actually observed findings. Although some of the missing data are the result of non-attendance of a study participant at a planned visit, some are related to non-compliance with the study protocol on the part of the researchers, such that no tests or evaluations are performed when the study participant attends a visit.

There is often a difference in documentation between the general informed consent form and the consent form required for collection of biological samples. Questionnaires and patient diaries, which are completed by the study participants themselves, could contain errors that need to be corrected using appropriate criteria. Researchers require education and training in how to adjust for such errors so that they can assess outcomes in a consistent way. Another common problem is lack of efficient management of clinical trial documents; for example, the investigator site file is not updated in many cases. Furthermore, essential CRF documents are sometimes missing because the information was not entered at the time of the subject’s visit. All these deviations can be prevented by education and training of researchers and monitoring to improve the quality and credibility of the study data through a QA plan ( Table 1 ).

Common findings of protocol deviation or trial misconducts in complementary and alternative medicine trials.

Monitoring is a major component of QA that can ensure the transparency and credibility of data acquired in clinical trials. Given that clinical studies in the field of CAM are on the rise and the increasing need to improve the quality of clinical studies along with quantitative growth, sponsors and researchers conducting clinical studies have to ensure a study monitoring plan. When performing clinical trials for development of CAM-related interventions, the QA monitoring recommended in GCP should be a mandatory element in the course of CAM research.

Author contributions

Conceptualization: S-YJ, JWK and T-HK Methodology: S-YJ, JWK and T-HK. Formal Analysis: S-YJ, JWK and T-HK. Investigation: S-YJ, JWK and T-HK. Resources: S-YJ, JWK and T-HK. Writing – Original Draft: S-YJ, JWK and T-HK. Writing – Review & Editing: S-YJ, JWK and T-HK. Supervision: T-HK. Project Administration: T-HK.

Conflicts of interest

There is no conflict of interest in all the authors.

This research did not receive funding from any source.

Ethical statement

There is no data which might be related to the ethical issue.

Data availability

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Computer Science > Computation and Language

Title: from text to transformation: a comprehensive review of large language models' versatility.

Abstract: This groundbreaking study explores the expanse of Large Language Models (LLMs), such as Generative Pre-Trained Transformer (GPT) and Bidirectional Encoder Representations from Transformers (BERT) across varied domains ranging from technology, finance, healthcare to education. Despite their established prowess in Natural Language Processing (NLP), these LLMs have not been systematically examined for their impact on domains such as fitness, and holistic well-being, urban planning, climate modelling as well as disaster management. This review paper, in addition to furnishing a comprehensive analysis of the vast expanse and extent of LLMs' utility in diverse domains, recognizes the research gaps and realms where the potential of LLMs is yet to be harnessed. This study uncovers innovative ways in which LLMs can leave a mark in the fields like fitness and wellbeing, urban planning, climate modelling and disaster response which could inspire future researches and applications in the said avenues.

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  1. Site Monitor Visits

    Pre-study visits (site selection visits or site qualification visits (SQVs)) are conducted to determine if the investigator and clinical site have the capability to conduct the study. During this visit, both an investigator and a study coordinator must be available. When applicable, pharmacy staff may also need to be available.

  2. PDF Pre-Study Site Selection Visit

    This SOP describes the steps to be followed from the time a pre-study site visit is scheduled with a sponsor, until all follow-up activities associated with the visit have been completed. III. RESPONSIBILITY: This SOP applies to investigators, other key research personnel and support staff involved in arranging, managing, or participating in ...

  3. ICH GCP

    It is important to read the Pre-Study Visit and Site Initiation Visit (SIV) reports, as well as the last one-two Interim Monitoring Visit (IMV) Reports (to clarify: the site's location, site staff roles and responsibilities, the contact person at the site, the number of previous IMVs, the typical problems identified at the site, and the ...

  4. Monitoring Visit Reports: An Overview of Different Types of Visits

    Pre-Study Visits (PSV) Explained. To start off, in order for a sponsor or CRO to confirm if a site will be used for a study or not, a CRA will need to perform what's called a pre study visit, a PSV. This is also known as a site selection visit. depending on what company you work for. And this visit is performed in order to determine if an ...

  5. PDF PRE-STUDY QUALIFICATION VISIT REPORT

    Provide a summary of the results, if applicable, in comment section. y Obtain copy of any FDA 483s, Warning Letters or other reports / correspondence and any response letter(s) from the site to FDA. Please complete all questions. For documents, answer YES only if the document is present and correct.

  6. PDF Monitoring & Auditing of Clinical Trials

    Pre-study Qualification Visit • Purpose: Determine the site's ability to conduct the clinical trial prior to commencement of the investigation. often place new trials at sites with a good track record of success • Goal of the pre-study qualification visit: • Visit the site • Meet with study staff • Inspect the facilities

  7. PDF SOP-05: Site Qualification Visit

    SOP-05 describes the process for conducting a site qualification visit, also known as a pre-study site visit. Attachment templates include: A: Site Qualification Visit Agenda . ... PI will identify key research personnel that will be involved in the conduct of the clinical research study. In preparation of the visit, a Site Qualification Visit ...

  8. Screening and Preparing for a Study Visit

    Access Subject Schedule by Enrollment. Prior to each study visit, the research team must be prepared for all known and unknown tasks that may need to be completed per protocol. If applicable, physician orders need to be completed and authorized for lab draws, study medication and additional testing; research lab kits should be prepared and ...

  9. Working with Milestones (Clinical Operations)

    For example, if you create a Pre Study Visit monitoring event, Vault creates a Pre Study Monitoring Visit milestone. Keep in mind that Vault only creates Milestones for the following standard monitoring event types: Interim Monitoring Event, Pre Study Visit, Site Close Out Visit, and Site initiation Visit.

  10. Tools and Resources Productive Clinical Monitoring Visits

    Evaluate Study personnel to ensure all are appropriately delegated and trained to perform Study procedures. Assess the Site facilities for any changes since the Pre-Study Visit. Meet with the Principal Investigator (PI) and other Site staff to review the overall progress of the Study and the CRA's findings.

  11. Site Preparation Checklist (Pre-Study Visit)

    Site Preparation Checklist (Pre-Study Visit) Download the Site Preparation Checklist for Pre-Study Visits (PDF). Office of the Vice Chancellor for Research MSC 1054-87-1600 Washington University 1 Brookings Drive St. Louis, MO 63130 [email protected]. Core Research Facilities. Roles and Responsibilities.

  12. 8. Essential documents for the conduct of a clinical trial: ICH E6 (R2

    PRE-TRIAL MONITORING REPORT. To document that the site is suitable for the trial (may be combined with 8.2.20) X. ... MONITORING VISIT REPORTS. To document site visits by, and findings of, the monitor : X. ... CLINICAL STUDY REPORT . To document results and interpretation of trial. X (if applicable) ...

  13. Introduction to the Monitoring in Clinical Trials, Pre-Study Site

    Pre-Study Site Selection Visit (PSSV) This is the starting point of interactions between Sponsor/CRO and Clinical Trial Site. It is performed after the Site Identification & Feasibility process has been completed. The PSSV is performed to ensure that:

  14. PDF Standard Operating Procedure for Pre-study Site Visit (Pssv)

    A. Agenda for Pre-study Site Visit (PSSV) B. Checklist of Activities Associated with the Pre-study Site Visit C. Pre-study Site Visit Follow-up 6. RESPONSIBILITY This SOP applies to Georgia CORE staff members and others involved in arranging, managing, or participating in the pre-study site visit. This may include one or more of the following:

  15. Pre-Study Preparation

    To make sure you are prepared to conduct the trial, do a walk-through of the research procedures before you schedule the first visit: Confirm pre-screening steps in Epic and ORCA; Create visit packets that contain your recruitment, consent, and data collection resources you will use when approaching participants

  16. CRA Soft Skills for Pre-Study Evaluation Visits

    The CRA should understand that the pre-study visit is a reciprocal consideration. The site personnel are assessing the CRA as much as the CRA is assessing them. If the CRA is informative, patient, and positive, it will result in transparent and professional dialogue that illuminates and engages all players.

  17. First Study Visit Success

    Prior to the study visit: Make a checklist of important steps throughout the day. Review the protocol. Create and/or review study quick-reference guides. Ensure that all study-related equipment is functioning properly. Place reminder calls to subjects. Have subject contact numbers and names of CRO or sponsor handy for questions.

  18. Pre-Study Visit

    Updated February 15, 2023. A pre-study visit is a site evaluation that is conducted prior to the initiation of a clinical trial. It is typically performed by a representative from the sponsor or the CRO and is designed to assess the site's readiness and capability to conduct the study. The purpose of the this visit is to ensure that the site ...

  19. Mastering Pre-Study Site Selection Visit

    The Mastering Pre-Study Site Selection Visits in Clinical Research program is designed to provide clinical research professionals with the knowledge and skills needed to effectively plan, conduct, and follow up on pre-study site selection visits. Participants will gain an understanding of the critical role these visits play in ensuring successful trial initiation and adherence to regulatory ...

  20. Detailed video on the Pre-Study Visit (PSV) / Site Selection Visit (SSV

    How to conduct a Pre-Study Visit / Site Selection Visit

  21. Clinical Research Site Feasibility and Site Selection Visits

    Upon submission of the CDA, a protocol synopsis following and a feasibility survey will be sent out to the site. Feasibility surveys contain specific inquiries for consideration in relation to the goals set forth by the sponsor for the study to be awarded to the site. Once all of this is completed, a 1-4 hour visit will be scheduled in order ...

  22. ICH GCP

    It is important to read the Pre-Study Visit and Site Initiation Visit (SIV) reports, as well as the last one-two Interim Monitoring Visit (IMV) Reports (to clarify: the site's location, site staff roles and responsibilities, the contact person at the site, the number of previous IMVs, the typical problems identified at the site, and the ...

  23. Monitoring in clinical trials of complementary and alternative medicine

    During the pre-study site visit, the research capability of the site is assessed considering the adequacy of facilities, recruiting ability, and the expertise of the investigator (s). After the study protocol is approved by the institutional review board and local regulatory agency (if necessary) and the investigational products are ready for ...

  24. [2402.16142] From Text to Transformation: A Comprehensive Review of

    Download PDF Abstract: This groundbreaking study explores the expanse of Large Language Models (LLMs), such as Generative Pre-Trained Transformer (GPT) and Bidirectional Encoder Representations from Transformers (BERT) across varied domains ranging from technology, finance, healthcare to education. Despite their established prowess in Natural Language Processing (NLP), these LLMs have not been ...