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Clinical trial basics: site initiation visit (siv).
What is an SIV in clinical research?
SIV Definition: Site initiation visit
An SIV (clinical trial site initiation visit) is a preliminary inspection between the sponsor and the trial site before the enrollment and screening process begins. It is conducted by a monitor or clinical research associate (CRA), who reviews all aspects of the trial, from protocol to staff training. [ 1 ][ 2 ]
Also known as a study start-up visit, the sponsor can only request an SIV after the site has been selected and agreements such as the CTA and CDA have been signed.
What is the purpose of an SIV?
Clinical trial SIVs are necessary to ensure that all personnel involved in the clinical trial, such as investigators and study staff, thoroughly understand the trial protocol and are trained to handle their role and responsibilities.
Furthermore, a site initiation visit ensures the trial site is operational-ready with working infrastructure, tools, and materials which helps streamline future efforts such as recruitment. [ 1 ]
Given the scope of the SIV, clinical trial sponsors should schedule this visit well before enrollment so that there is plenty of time to comprehensively inspect all relevant processes.
Can the SIV be conducted before IRB approval?
IRB approval is necessary before an SIV. Clinical trial sponsors need to be sure they have selected a site that has fulfilled all the necessary regulatory requirements and is operating in compliance with IRB guidelines.
SIV checklist for thorough site initiation visits
Given the importance of an SIV, clinical trial sponsors and CROs need to make the most of this inspection visit by coming fully prepared with a detailed checklist that outlines the SIV.
Clinical trial sites should also have a copy of this checklist to ensure all relevant staff is present. Specific tasks to include in the SIV checklist include the following tasks: [ 1 ] [ 2 ][ 3 ][ 4 ]
- Discussing clinical trial objectives with study staff
- Educating the research team on Good Clinical Practices
- Reviewing the operation schedule for the protocol
- Discussing the enrollment and screening process, including clarifying inclusion and exclusion criteria
- Reviewing the informed consent protocol
- Clarifying the procedure of storing and dispensing the investigational drug
- Checking inventory for all medical supplies and equipment
- Ensuring access to all digital platforms, i.e., correct usernames and passwords
- Touring the clinical trial site
- Reviewing and discussing all clinical trials documentation, such as forms, surveys, and manuals
- Reviewing the data management system
- Ensuring clinical trial staff understand how to maintain essential documentation
- Reviewing the financial protocols, including any processes related to compensating trial participants
- Checking reporting systems for possible adverse events
- Discussing specific concerns trial staff may have
This checklist provides the basic guidelines that can be used to build upon to create a complete agenda for an SIV. Clinical trial sponsors can add to these as required per their clinical trial design.
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- 6: Notification of a Serious Breach
- 8: Case Report Form Design
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Initiation of an Investigator Site
Initiation of a trial site ensures that all required trial authorizations and documentation are in place and that the protocol and trial procedures are reviewed with the investigator and the investigator’s trial staff in accordance with the protocol, SOPs, GCP, and the applicable regulatory requirement(s).
Initiation is integral to the QC of a clinical trial and is designed to ensure quality of the trial according to Sponsor requirements and to ensure that all necessary documents are in place to facilitate conduct and ongoing documentation of the trial.
Related Documentation
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STANDARD OPERATING PROCEDURE (SOP) FOR CLINICAL RESEARCH Title: Site Initiation Visit Last Revised: 8/2017 Prior Version: 10/2014, 05/2011 SOP NUMBER: SS-303 Page 1 of 3 Developed by the UH Clinical Research Center SOP Committee 1. PURPOSE: To outline the protocol specific activities required to facilitate the research site initiation process. ...
Page 1 of 4. SOP-08: Site Initiation Visits. 1. Objective. To ensure that the Principal Investigator (PI) and all research team members assisting in the conduct of clinical research are informed about their obligations and responsibilities as they pertain to Good Clinical Practices (GCP), the investigational plan, applicable regulations ...
SS-204.01 SOP For Site Initiation Visit Effective date of version: 01 June 2017 Replaces previous version 204.01: 01 July 2014 Georgia Center for Oncology Research and Education Page 1 of 15 Study Start-Up SS-204.01 STANDARD OPERATING PROCEDURE FOR Site Initiation Visit (SIV) Approval: Nancy Paris, MS, FACHE President and CEO 24 May 2017
The purpose of this Standard Operating Procedure (SOP) is to describe the procedures to be carried out when initiating a new Participating Site (including RCH if they are a participating site) for a clinical trial sponsored by the Murdoch Children's Research Institute (MCRI). The purpose of the site initiation (SI) is:
A Site Initiation Visit (SIV) or Study Start-Up is an organized meeting to discuss the new protocol before the research project is ready to screen and enroll potential patients. It also serves as training for the ... SOP SS-303 - Site Initiation Visit (PDF) Site Initiation Frequently Asked Questions (SIV FAQs) (Word .doc)
This SOP applies to principal investigators (PIs) and other key research personnel involved in managing or participating in the site initiation visit or study communications. IV. PROCEDURES: A. Preparing for the site initiation visit: 1. Coordinate the site initiation visit schedule to assure PI availability. 2.
SITE INITIATION VISIT. SOP#: 3. 0. 3. Effective Date: 06/01/2016. Version: 1.0. Page . 3. of . 3. PURP. O. SE: The purpose of this SOP is to describe activities that will be accomplished by site staff before, during and after the sponsor's Site Initiation Visit (SIV) using a checklist to outline the critical study requirements and procedures ...
1. Prior to conducting the site initiation visit, the Project Monitor and Hub Complex designee will: a) Correspond with the Hub and/or Spoke PI, or designee to schedule the site visit at a mutually agreed upon time. b) Provide an agenda of activities, including a list of site personnel required for each, in the form of a Pre-Visit Site letter. 2.
The Site Initiation Visit (SIV) prepares the research site to conduct the research study. This meeting generally takes place after the investigational site has received IRB approval and a Clinical Trial Agreement (CTA) has been fully executed. In addition, the SIV should occur prior to the first subject enrollment. The PI or member of
An SIV (clinical trial site initiation visit) is a preliminary inspection of the trial site by the sponsor before the enrollment and screening process begins at that site. ... SOPs, etc. Reviewing the data management system and any other technological solutions forming part of the site's or sponsor's workflow; Ensuring that site staff are ...
Set up Investigator Site file as per SOP 45 Study Specific Essential File Documentation It is advised that the Investigator Site File (ISF) are set up centrally and distributed to sites as part of Site Initiation Visit (SIV). Site initiation 7. CI or delegate Perform site SIV at each site, train site staff, resolve all issues, and
This standard operating procedure (SOP) describes the processes followed by Georgia CORE when conducting site visits at the conclusion of a study. Georgia CORE is responsible for final review ... (See SOP SS-204.00 Site Initiation Visit, Attachment D Site Visit Log) Ensure that any equipment loaned to the site for the study is
The Site Initiation Visit (SIV) prepares the research site to conduct the research study. This meeting generally takes place after the investigational site has received IRB approval and a Clinical Trial Agreement (CTA) has been fully executed. In addition, the SIV should occur prior to the first subject enrollment. The PI or member of
Published Nov 15, 2016. A Pre-Selection Visit (PSV) is to ensure pre-qualification of a site and eliminate sites that do not possess adequate qualities to conduct the trial and must occur in order ...
Site initiation visit complete, including Study Start Up for CTEP-sponsored studies . Communication from CC DTM that cells can be processed . Communication from research lab that specimens can be processed, etc. CCR study database built . CRIS order sets submitted to DCRI . Notification from study sponsor that study may be activated at site
The following pre-requisites should be completed prior to the initiation visit: protocol and consent have been submitted to any required scientific review committee, the DSMB/CSOC (if applicable), and the IRB; the case report forms and data collection system are near final; the MOP and/or Standard Operating Procedures (SOPs) are near-final; the ...
Site Initiation Visits and SOP 09: Protocol Implementation). This meeting will review the following, but is not limited to: 1. Written IRB approval for the study and supportive study documents have been received, final documents are available to the study team and essential regulatory documents are completed,
during the site selection visit [SOPs 316 and 317].) - Ethics committee/IRB requirements (e.g. membership, waiting period for meetings, documentation to submit for ... initiation visit (SOP 329) to brief all the staff associated with the study, as a group, if possible. 316.13. In the case of a multicentre study,
SIV Definition: Site initiation visit. An SIV (clinical trial site initiation visit) is a preliminary inspection between the sponsor and the trial site before the enrollment and screening process begins. It is conducted by a monitor or clinical research associate (CRA), who reviews all aspects of the trial, from protocol to staff training.
6.6. Prior to the Site Initiation Visit (SIV), site essential regulatory documents are submitted to the SROS ERDG. 6.6.1. Documents should be submitted 4 - 8 weeks prior to the anticipated SIV date to allow sufficient time to review and verify the clinical trial records. 6.6.2. SROS ERDG reviews the submitted site essential regulatory ...
Initiation is integral to the QC of a clinical trial and is designed to ensure quality of the trial according to Sponsor requirements and to ensure that all necessary documents are in place to facilitate conduct and ongoing documentation of the trial. SOP: Initiation of an Investigator Site V4.2 (.pdf 959KB) Related Documentation
SS-204.01 SOP For Site Initiation Visit Effective date of version: 01 April 2012 Replaces previous version 204.00: 01 June 2010 Georgia Center for Oncology Research and Education Page 1 of 15 Study Start-Up SS-204.01 STANDARD OPERATING PROCEDURE FOR Site Initiation Visit (SIV) Approval: Nancy Paris, MS, FACHE President and CEO 08 March 2012
SOP 201: Regulatory Documentation; SOP 204: Adverse Event Reporting; SOP 302 Site Qualification Visit; SOP 303 Site Initiation Visit; SOP 304 Communication Practices; SOP 305: Investigational Product Accountability; SOP 311: Study Close-Out Visit; SOP 501: Case Report Completion; SOP 502: Source Documentation.