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) — sometimes called a site activation visit — is the monitoring visit that formally clears an investigational site to begin enrolling participants in a specific clinical trial. It is conducted by the trial’s monitor, most often a Clinical Research Associate (CRA) employed by the sponsor or a contract research organization, and it functions as a final readiness check before the site is allowed to screen its first participant.
What the monitor confirms during an SIV
An SIV is not a single form or signature — it is a structured review across several readiness domains, all of which need to be satisfied before the site is activated:
- Regulatory approval: current IRB/IEC approval of the protocol and informed consent form (and, for IND/IDE-regulated US trials, a properly executed FDA Form 1572 where applicable).
- Staff training and delegation: every individual listed on the delegation-of-authority log has completed protocol-specific training and Good Clinical Practice (GCP) training appropriate to their role, consistent with ICH E6(R2) Principle 2.8’s requirement that trial personnel be qualified by education, training, and experience.
- Essential documents: the site regulatory binder (Trial Master File contribution) is complete per the pre-trial document categories set out in ICH E6(R2) Section 8 — see CASRAI’s Inspection Readiness term for how this same document set is later reviewed under regulatory inspection.
- Investigational product and supplies: the site’s pharmacy or designated storage area has received the investigational product (or device), and accountability/receipt procedures are in place and understood.
- Operational readiness: site staff understand source-documentation practices and the study’s electronic data capture (EDC) system, and study-specific equipment and facilities (e.g., -20°C freezer, ECG machine, controlled-access pharmacy) are confirmed functional.
Only once the monitor is satisfied on all of these does the site receive activation to begin screening and enrolling participants for that protocol.
Where the SIV sits in the site-visit sequence
Clinical operations commonly organizes monitoring visits into a sequence, of which the SIV is one recognized stage — this is an established industry convention rather than a term defined verbatim by ICH E6 itself:
- Site selection / pre-study visit — before the site is contracted, evaluating whether to choose it for the trial.
- Site Initiation Visit (SIV) — after contracting and IRB approval, confirming the site is ready to open and enroll.
- Routine / interim monitoring visits — during active enrollment, reviewing source data, drug accountability, and safety reporting on an ongoing basis.
- Close-out visit (COV) — after the site’s participation ends, reconciling supplies and confirming records retention.
Confusing an SIV with a site-selection visit or a routine monitoring visit is a common terminology slip: the SIV is specifically the one-time activation gate between site selection and the start of enrollment.
On-site vs. remote SIVs
SIVs have traditionally been conducted in person, but remote (videoconference-based) SIVs became widely adopted industry practice during the COVID-19 pandemic and remain common, particularly for lower-risk trials or geographically distant sites. A remote SIV covers the same readiness checklist — documents are typically reviewed by screen-share, and facility/storage walkthroughs are conducted by camera — rather than a different or reduced set of requirements.
Who is responsible
The monitor (CRA) typically leads and documents the SIV, but attendance usually also includes the principal investigator, sub-investigators, the study coordinator, and sometimes pharmacy or clinical-operations staff from the sponsor. The monitor’s determination that a site has passed its SIV is recorded in the trial’s monitoring documentation and becomes part of the site’s essential-document file.
Machine-readable encodings
Use in your systems
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