Examples
Worked examples
- Is an instance
A CRA travels to a newly contracted oncology trial site two weeks after IRB approval is granted. During the SIV, the CRA reviews the site's delegation-of-authority log, confirms every listed staff member has completed protocol-specific and GCP training, verifies the IRB approval letter and current investigator's brochure are filed in the regulatory binder, checks that the pharmacy can account for the investigational product shipment, and walks through source-document and EDC data-entry procedures with the coordinator. Only after confirming these items does the CRA authorize the site to begin screening participants.
- Is an instance
For a multi-region device trial, the sponsor holds a remote SIV by videoconference: the CRA reviews the site's completed regulatory documents by screen-share, confirms via camera a walkthrough of the investigational-device storage area, and holds a live session with the site coordinator and sub-investigators on protocol-specific procedures -- before authorizing enrollment to open at that site.
Counter-examples
Looks similar, but isn't
- Not an instance
A visit where a CRO monitor evaluates a prospective site's facilities, patient population, and staff experience to decide whether to select it for a trial is a site-selection visit (pre-study visit), not an SIV -- it happens before the site is contracted or IRB-approved, and its purpose is choosing a site, not activating one already chosen.
- Not an instance
A monitor's visit during ongoing enrollment to perform source data verification, check drug accountability, and review adverse-event reporting is a routine (interim) monitoring visit, not an SIV, because the site is already active and enrolling participants.
- Not an instance
A monitor's final visit after the last participant completes the study, reconciling drug supplies and confirming records retention, is a close-out visit (COV), not an SIV -- it happens at the opposite end of the site's participation in the trial.
Editorial commentary
A site initiation visit (SIV) is the on-site or remote visit a clinical trial sponsor or CRO monitor conducts at a research site after the site has been selected and qualified, but before the site enrolls its first participant. The SIV formally activates the site for enrollment.
What happens at an SIV
A typical SIV covers: protocol-specific training for investigators, sub-investigators, and study coordinators; review of the informed consent process and current IRB/ethics-committee-approved consent form; confirmation that all required regulatory documents (IRB approval letter, investigator’s brochure acknowledgment, signed protocol and financial disclosure forms, delegation-of-authority log) are complete and on file; verification that investigational product and any required trial supplies have been received and are stored correctly; and a walkthrough of source-document and case-report-form completion expectations. The monitor typically confirms in writing that the site is ready before enrollment opens.
SIV vs. other trial-operations visits
An SIV is distinct from a site qualification visit (which happens earlier, before the site is selected, to assess feasibility) and from routine monitoring visits (which happen throughout the trial to review ongoing conduct and data quality, once enrollment is underway).
References
- ICH E6(R2) Good Clinical Practice guideline
- Sponsor/CRO clinical monitoring plan templates
Frequently Asked Questions
What does SIV stand for in clinical trials?
SIV stands for site initiation visit: the visit a clinical trial sponsor or CRO monitor conducts at a research site to formally activate it for enrollment, after the site has been selected and qualified.
Is a site initiation visit conducted in person or remotely?
It can be either. An SIV is defined by what it accomplishes, not its format, and sponsors and CROs conduct it either on-site or as a remote visit.
Who conducts a site initiation visit?
A clinical trial sponsor or CRO monitor conducts the SIV at the research site.
Can a clinical trial site enroll participants before its SIV?
No. The SIV takes place after a site has been selected and qualified but before it enrolls its first participant, and it is the visit that formally activates the site for enrollment. The monitor typically confirms in writing that the site is ready before enrollment opens.
What is the difference between a site initiation visit and a site qualification visit?
A site qualification visit happens earlier, before a site is selected, to assess whether it is feasible for the trial. The SIV happens later, after the site has already been selected and qualified, to activate it for enrollment.
What is the difference between an SIV and a routine monitoring visit?
The SIV happens once, before enrollment begins, to activate the site. Routine monitoring visits happen repeatedly throughout the trial, once enrollment is underway, to review ongoing conduct and data quality.
Machine-readable encodings
Use in your systems
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