Site initiation visit checklist: what to confirm before the first participant

This guide is for study coordinators, research nurses, investigators and new monitors (CRAs) in hospitals, universities and contract research organizations. It is the pillar of our series on clinical studies and reporting. It is general guidance, not regulatory advice: your sponsor's SOPs, the protocol, your institution's rules and ICH GCP govern what you must do.

What a site initiation visit is (and what it is not)

A site initiation visit is the set-up and training visit that happens after a site has been selected and approved, and before it enrolls its first participant. The sponsor, usually through its monitor, confirms that the site is ready and trains the site team on the protocol and the sponsor's procedures.

It is one of four visits in the life of a trial site, and they are easy to confuse:

An SIV is not the time to discover that the ethics approval is missing or the contract is unsigned. Those belong before the visit is booked. The SIV confirms and trains; it should not be the first time anyone checks.

Who attends

The rule of thumb: anyone whose name will be on the delegation log should attend the parts that concern their tasks.

Send the agenda and the slides ahead, and ask staff who cannot attend to complete training before they take on any task. Everyone signs the training log.

The site initiation visit checklist

Use this as a working list. Tick only what you have seen, not what someone says is done. Sponsors have their own forms; map this onto theirs rather than replacing them.

1. Approvals and agreements

• Ethics committee or IRB approval of the current protocol version, consent form and participant materials (with version numbers and dates matching the documents in use)
• Regulatory authority approval or notification, as required in your country
• Local institutional approvals (research governance, radiation, biosafety, data protection) where required
• Signed clinical trial agreement and budget
• Insurance or indemnity documents, where required

2. Investigator site file (regulatory binder)

The investigator site file (ISF), called the regulatory binder in many US sites, holds the site's essential documents. Check it against the sponsor's index.

• Signed protocol and any amendments, with the PI's signature page
• Investigator's brochure or product information, current version
• Approved consent form and participant materials, every version
• Approval letters and correspondence with the ethics committee and regulator
• CVs (signed and dated), GCP training certificates and professional licenses for everyone on the delegation log
• Financial disclosure forms, where required
• Form FDA 1572 for US IND studies
• Laboratory certification or accreditation and normal ranges
• Logs ready: screening, enrollment, delegation, training, monitoring visits, temperature, sample, IP accountability
• A place for the SIV report and future monitoring correspondence

3. Delegation log

• Every person who does trial tasks is on it, with the tasks delegated to them
• Each task matches that person's training, qualifications and license (only a qualified person assesses eligibility or adverse events)
• Signed and dated by the PI, with start dates; no one acts before their entry is signed
• Signature and initials specimens, so entries in source and CRFs can be traced

4. Training

• Protocol training: objectives, design, eligibility, visit schedule, procedures, prohibited medication, endpoints and how they are measured
• Study-specific procedures and manuals (lab manual, pharmacy manual, imaging manual)
• GCP training current for all staff, per the sponsor's requirement
• Training log signed by every attendee, with the date and the topics
• A plan to train staff who join later

5. Informed consent process

• The current approved version is the one on file and in use; superseded versions are marked and removed from use
• Who may take consent (and it matches the delegation log)
• How consent is documented in the source notes (date, time, version, who took it, that questions were answered and a copy given)
• Translated versions, interpreters and impartial witnesses, where needed
• Assent and parental permission for children, and what happens when a child reaches adulthood
• The re-consent process when the consent form is amended

6. Investigational product (IP) and pharmacy

• Shipment received (or the date it will be), and the receipt recorded
• Secure storage with restricted access, at the labeled temperature
• Temperature monitoring and the excursion procedure (who to call, quarantine)
• Accountability log: dispensed, returned, destroyed; reconcilable to the unit
• Dispensing and preparation instructions; pharmacy staff trained
• Randomization system access (IRT/IWRS) and the emergency unblinding procedure

7. Laboratory and samples

• Lab kits in date and in enough quantity
• Collection, processing, storage and shipping procedures understood
• Centrifuge, freezers and fridges available, with temperature logs
• Courier accounts, shipping materials and dangerous goods training where needed
• Central or local lab: who receives results and how they are reviewed and signed

8. Equipment and facilities

• Equipment the protocol relies on (ECG, scales, blood pressure monitors, spirometers) is calibrated or maintained, with records
• Space for visits, confidential storage for records, and secure archiving
• Emergency equipment where the protocol requires it (for example, for first dosing)

9. Data collection: eCRF and source

• Accounts for the electronic data capture (EDC) system for everyone who enters or signs data, with training completed
• Agreement on what counts as source documents for each data point (and documented in a source document agreement or list)
• How queries are raised, answered and closed, and the timelines
• Access for the monitor to medical records for source data verification, in line with consent and local rules

10. Safety reporting

• Definitions: adverse event, serious adverse event, and any adverse events of special interest in the protocol
• Reporting timelines: serious adverse events to the sponsor within the protocol's deadline (commonly 24 hours of the site becoming aware)
• Forms, the reporting route (EDC or paper), and the sponsor's safety contacts, including out of hours
• How the investigator assesses seriousness, severity and causality, and who may do it
• Pregnancy reporting and follow-up, where relevant
• Reporting to the ethics committee, as local rules require

11. Monitoring and recruitment

• The monitoring plan: visit frequency, on-site or remote, source data verification and the first visit after first enrollment
• Screening and enrollment logs set up
• Recruitment plan and target, and the approved recruitment materials
• Protocol deviations: how to record and report them

12. Close of the visit

• Open questions answered or logged
• Every action has an owner and a due date
• Date for the SIV report and the site's response
• The condition for site activation (often written confirmation from the sponsor once actions close)

After the visit

1. The monitor writes the SIV report and a follow-up letter listing what was reviewed, who attended and the open actions. File both in the ISF.
2. The site closes the actions and sends evidence: a signed log, a missing CV, a corrected temperature record.
3. The sponsor activates the site in writing. Enrollment starts only after activation, not after the visit itself.
4. The first monitoring visit is usually scheduled soon after the first participant, to catch early errors in consent, eligibility and data entry.
5. Keep the file current. New staff are trained and added to the delegation log before they work; amendments are approved, trained and filed before use.

Common mistakes

• Version mismatch. The consent form in the clinic is not the version the ethics committee approved. Check the version and date on every copy.
• Delegation before signature. A nurse takes consent before the PI signed her delegation entry. Every task done before the entry is a deviation.
• Training only at the SIV. Staff who joined a month later never signed the training log.
• IP arrives before it can be stored correctly. No continuous temperature record, or an uncalibrated fridge.
• Unclear source. Nobody agreed whether the eCRF or the hospital record is the source for vital signs, and the monitor finds two different values.
• Safety contacts that do not answer at night. Test the out-of-hours route.

A worked example (invented)

Example (invented for illustration). A university hospital is joining a phase 3 trial of an inhaled therapy. Two weeks before the SIV, the coordinator works through the checklist with the monitor by email. Three points are open: the pharmacist's GCP certificate expired last month, the spirometer's calibration record is from last year, and the Spanish consent form is approved but the translator's attestation is not in the ISF. At the SIV the PI, two sub-investigators, two nurses, the pharmacist and the lab manager attend; the training log is signed; the pharmacy tour confirms storage and temperature logging. The SIV report lists the three open items, each with an owner and date. They close within ten days, and the sponsor sends the activation letter.

Doing it in AI for Research

AI for Research includes the site initiation visit checklist as one of its Study checklists in Proposal Studio (/proposals?module=study-checklist, group "Checklists"). Two ways to use it:

• Blank template, free. Open the "Checklist: site initiation visit" template in the editor (0 credits). It has the sections above: approvals and agreements, the investigator site file, delegation log, protocol training, consent process, investigational product, safety reporting, data collection, monitoring, samples and laboratory, equipment, recruitment, and close of the visit.
• Tailored to your study, 3 credits. Describe the study (design, population, product, sites, languages, the committee involved) or upload the protocol synopsis, and the module returns the checklist fitted to it: the storage conditions your product needs, the samples your lab manual names, the languages your consent forms need.

The output is a working draft. It does not know your sponsor's SOPs or your country's rules unless you give them, and it is not regulatory advice; your monitor, PI and institution confirm what applies. The Free plan has 45 credits a month; see pricing for paid plans. More on the module: clinical research checklists.

The same module covers the other checklists in this series: an IRB submission, ClinicalTrials.gov results posting, consent translation, and a genomics incidental-findings plan.

Learn more

• ClinicalTrials.gov results reporting: what to post, when, and the review comments to avoid
• SAGER guidelines: reporting sex and gender in your trial publication
• SAMPL guidelines: reporting the statistics
• How to write an IRB application
• Clinical research checklists and AI for medicine