Site Initiation Visit (SIV) Checklist: Regulatory, DoA, Training, IP, and Pharmacy Readiness

A Site Initiation Visit (SIV) is the final readiness check before a clinical trial site can enroll its first participant — the point at which a sponsor or CRO monitor confirms that every regulatory, training, and operational prerequisite from study start-up is actually in place, not just in progress. Because the SIV is a single visit with a hard pass/fail outcome (the site is activated or it isn’t), sites and monitors both work from a checklist rather than relying on memory. This guide lays out that checklist in the five areas an SIV actually covers: regulatory documents, the delegation-of-authority log, staff training records, investigational product (IP) accountability, and pharmacy readiness — plus the logistics and system-access items that round out a typical agenda.

What the SIV checklist is for

The SIV itself is usually conducted by a clinical research associate (CRA) or sponsor representative, in person or remotely, and follows a written agenda. Its job is to verify — not to complete — site readiness: everything on the checklist below should already be assembled before the visit, so the SIV functions as a confirmation exercise rather than a scramble. This maps directly onto ICH E6(R2) Section 8, which defines essential documents as “those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced,” and groups them by whether they belong before, during, or after the trial. Most SIV checklist items are the “before the clinical phase commences” group of essential documents, confirmed as physically or electronically present and internally consistent — signatures dated, versions matching the currently approved protocol, no gaps in a required sequence (for example, a delegation log with no listed end date for a study still open at the site).

Sites preparing for their own SIV, and CRAs building or adapting a sponsor’s SIV form, can use this checklist the same way: work through it category by category, confirm what’s already been verified, and flag what’s missing before the visit date rather than during it.

1. Regulatory documents

• Currently approved protocol and any amendments, version-matched across the protocol, informed consent form (ICF), and any site-specific documents referencing protocol version numbers.
• Informed consent form — current IRB/EC-approved version, in every language the site will use, with the correct site/investigator identifiers.
• IRB/EC approval letter covering the protocol, current ICF, and any recruitment materials, plus documentation of IRB continuing-review dates if applicable.
• Signed and current FDA Form 1572 (Statement of Investigator), for FDA-regulated drug/biologic trials — confirm the listed subinvestigators match the delegation log and that no protocol has been added since the 1572 was last signed without a corresponding update.
• Investigator’s Brochure (IB) acknowledgment of receipt, current edition.
• Financial disclosure forms (21 CFR Part 54) for the PI and listed subinvestigators.
• Site and, where applicable, central IRB/EC registration documentation, and confirmation the site’s CVs and medical licenses on file are current (not expired, correctly signed and dated).
• Executed clinical trial agreement (CTA) and budget, confirming the executed version matches what finance and the site’s contracts office are working from.

2. Delegation of Authority (DoA) log

ICH E6(R2) Section 4.1.5 requires the investigator to maintain a list of appropriately qualified staff to whom significant trial-related duties have been delegated. At SIV, the CRA is confirming the log itself, not just that one exists:

• Every staff member performing a trial-related task (consenting, drug dispensing, source documentation, data entry) is listed with their specific delegated tasks, not a blanket “study coordinator” entry.
• Start dates are present for every entry, and end dates are filled in for anyone who has left the study team.
• Each listed individual’s training record and CV/license are on file and current as of their listed start date — the DoA log and training records should cross-reference cleanly.
• The principal investigator has personally signed the log (delegation authority sits with the PI, not with a coordinator or sponsor).
• The log is being kept current going forward — SIV confirms the process for updating it exists, since it’s expected to be a living document for the life of the study at that site.

For a fully annotated walkthrough of what belongs in each DoA log field, see the Delegation of Authority Log Template guide.

3. Staff training records

• Protocol-specific training completed and documented for every individual listed on the DoA log, including a record of what was covered and when (not just a signature sheet).
• Current Good Clinical Practice (GCP) training/certification on file for the PI and all delegated staff, within whatever validity window the sponsor requires.
• Training on any protocol-specific procedures or equipment (electronic data capture system, specific lab kits, device use) documented separately from general GCP training.
• Human subjects protection / informed consent process training, particularly for anyone who will be obtaining consent.
• Confirmation of who at the site is trained and authorized to report adverse events and protocol deviations, and that they know the sponsor’s reporting timelines and mechanism.

4. Investigational product (IP) accountability

IP accountability setup is one of the areas SIV most commonly catches gaps in, because it spans clinical, pharmacy, and monitoring roles:

• IP has been received, and receipt has been documented (quantity, lot number, expiration/retest date, condition on arrival) against the shipment manifest.
• Storage conditions (temperature-controlled, secured/locked, access-restricted) match label and protocol requirements, with a documented temperature-monitoring and excursion process in place before any IP is dispensed.
• An IP accountability log or equivalent system is set up and ready to track dispensing, returns, and destruction/reconciliation for the duration of the study.
• Randomization and, if applicable, unblinding procedures are understood and access-controlled — confirm who at the site can access the randomization code and under what emergency-unblinding circumstances.
• Chain-of-custody and destruction/return procedures at study close are documented in advance, even though they won’t be exercised until much later.

5. Pharmacy readiness

Where a trial routes IP through a research pharmacy or Investigational Drug Service (IDS), SIV should confirm the pharmacy is independently ready, not just that clinical staff are:

• Pharmacy staff are listed on the DoA log if they perform delegated trial-related tasks, with their own training records on file.
• Pharmacy has protocol-specific dispensing instructions, dosing/titration schedules, and any required calculation or preparation worksheets.
• Storage, security, and temperature-monitoring requirements specific to the pharmacy’s role are confirmed independently of the clinical storage check above (pharmacy and clinic storage locations are often different and both need verification).
• For blinded studies, an unblinded pharmacist is designated and understands their role: accessing the randomization code to prepare and label investigational product and matching comparator or placebo, while remaining independent of subject outcome assessment.
• Pharmacy has a working process for documenting dispensing against the IP accountability log described above, so the two records will reconcile.

6. Systems, logistics, and administrative readiness

• Electronic data capture (EDC) / case report form (CRF) system accounts are provisioned for every delegated staff member who will enter data, with role-appropriate access levels.
• Source document templates or worksheets are prepared and match the data points the protocol and CRF require.
• Lab certifications (normal ranges, CLIA certification where applicable) and any central-lab kit supplies are on hand.
• Emergency contact information (medical monitor, sponsor safety contact, IRB) is posted or readily accessible to site staff.
• Monitoring visit log or equivalent tracking mechanism is set up for the ongoing monitoring visits that will follow SIV.

After the visit

A CRA typically leaves the SIV with an action item list for anything not yet resolved (a missing signature, an expired license awaiting renewal, an outstanding IRB continuing-review date). Site activation — clearance to begin screening and enrolling — normally follows once every open item is closed out and documented, not automatically at the end of the visit itself. Whichever items were reviewed and confirmed at SIV should also be filed in the site’s portion of the Trial Master File (TMF) (or eTMF), consistent with the essential-documents structure in ICH E6(R2) Section 8. For the full document inventory a TMF needs to be inspection-ready, see the companion Trial Master File Checklist.

Frequently asked questions

Who conducts the site initiation visit?

Typically a sponsor’s or CRO’s clinical research associate (CRA)/monitor, sometimes alongside a sponsor study team member. The PI and key delegated staff (study coordinator, pharmacy representative) are expected to participate, since the visit is confirming their specific readiness, not just the site’s paperwork.

How is the SIV different from a pre-study qualification visit?

A pre-study (site qualification) visit happens earlier, during site selection, and assesses whether a site is capable of running the study at all — facilities, patient population, staff experience. SIV happens later, after the site has been selected and contracted, and confirms that a specific, already-selected site has actually completed every start-up prerequisite and is ready to enroll.

Can a site initiation visit be conducted remotely?

Yes — remote or hybrid SIVs (document review conducted virtually, with or without a supplementary in-person facility check) are common, particularly for lower-risk trials or geographically distant sites, provided the sponsor’s monitoring plan permits it and the same document review is completed with equivalent rigor.

What happens if items on the checklist aren’t complete at SIV?

The visit itself still typically proceeds, but site activation is withheld until outstanding items are resolved and documented. The CRA usually issues an action item list with a follow-up deadline; enrollment does not open until every activation-gating item is closed.

Does every trial use the same SIV checklist?

No. The categories above (regulatory documents, DoA log, training, IP accountability, pharmacy readiness, systems) are consistent across most trials because they trace back to the same ICH E6(R2) essential-documents framework, but the exact checklist a sponsor or CRO uses is customized per protocol — for example, device trials, trials with no investigational drug component, or trials without a central pharmacy will have a shorter or differently weighted list.