The initiation visit is the last checkpoint before a site can enrol. This checklist covers what to confirm before the visit, a realistic agenda, the items to check area by area, and the action log that decides whether the site is cleared to start.
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Items
26
Done
21
Open
5
Key points
Purpose
By the time of the initiation visit, the site has usually been selected, the contract and budget agreed, and the ethics approval granted. What remains is practical: does everyone who will work on the study understand it, can they do it, and is everything in place to do it safely? The visit is where the monitor or study manager walks the team through the protocol, the procedures and the systems, and verifies the file, the facilities and the training.
It also creates a record. The attendance sheet, the training log, the completed checklist and the follow-up letter show that the site was ready at the time it started. For an investigator-initiated study with no external monitor, the same exercise is a team readiness meeting, led by the study manager and signed by the principal investigator. If you are the sponsor-investigator, see how to become a sponsor-investigator for the wider responsibilities.
Remote initiation is common, especially for small and decentralised studies. The checklist is the same; only the way you check physical items changes, for example by video walk-through of the storage area and shared screens for the systems. Agree the format with the sponsor in advance.
Before the visit
If any of these is missing, the visit will turn into a document chase. Send the list to the site with the agenda.
Approved protocol, version number, consent form versions, approval letter in the site file.
Both parties, dated, filed.
CV, training certificates and licence for each staff member who will be delegated tasks.
Compare against the investigator site file index template.
Investigational product only after required approvals; lab kits, equipment, forms.
EDC, safety reporting and any other tools; user list sent to the sponsor.
Investigator, sub-investigators, coordinator, nurse, pharmacist, lab lead, data entry staff.
So the team can read the protocol first.
Agenda
A realistic running order for a small multi-site study. Adjust the timings to protocol complexity. Times are examples.
| Time | Session | Lead | Output |
|---|---|---|---|
| 09:00 | Welcome, introductions, study overview and timelines | Study manager | Attendance sheet started |
| 09:30 | Protocol walk-through: objectives, design, eligibility, visits, endpoints | Monitor or study lead | Questions logged |
| 10:30 | Break | ||
| 10:45 | Informed consent process and participant materials | Study manager | Consent procedure agreed |
| 11:15 | Safety: adverse event definitions, SAE reporting timelines, escalation contacts | Medical lead | Contact sheet handed over |
| 11:45 | Investigational product: receipt, storage, accountability, returns | Pharmacist or monitor | Storage inspected or video-checked |
| 12:15 | Lunch | ||
| 13:00 | Data and systems: eCRF completion, queries, source documents, user accounts | Data manager | Accounts and roles confirmed |
| 14:00 | Samples, labs and equipment: handling, shipping, calibration | Lab lead | Equipment list signed |
| 14:30 | Site file, delegation log, deviations and documentation | Monitor | File reviewed |
| 15:15 | Questions, open items and sign-off | All | Action log drafted |
Name the start-up lead for the sponsor and the principal investigator for the site in the header of the agenda.
The checklist
Use one row per check. Mark each Yes, No or N/A, with a date and initials, and write actions in the log, not in the margin.
| Area | Check | Evidence |
|---|---|---|
| Approvals | Current protocol and consent versions are approved and are the ones in use. | Approval letters, version table |
| Investigator and staff | All staff are listed, qualified and have a signature on the delegation log. | Delegation log, CVs, GCP training certificates |
| Delegation | The investigator has signed each delegated task; no one will work before delegation. | See the delegation log template |
| Protocol understanding | Team can state eligibility, visit windows, key assessments and prohibited medication. | Training record, Q&A notes |
| Informed consent | Process, timing and documentation are clear; current consent form is available. | Consent SOP or procedure, sample form |
| Screening and enrolment | Screening log set up; plan for recruitment and pre-screening agreed. | See the recruitment plan template |
| Investigational product | Storage secure, temperature monitored, accountability log in place, responsible person named. | Storage check, IMP accountability log |
| Safety reporting | AE and SAE definitions known; timelines and contacts understood; reporting route tested. | Contact sheet, SAE report form template |
| Data capture | Users have accounts with the right roles; eCRF completion rules explained; query process explained. | User list, eCRF completion guidelines |
| Source documents | What counts as source for each data point is agreed; source locations are identified. | Source document list |
| Samples and labs | Collection, processing, storage and shipping steps are clear; kits and courier arranged. | Lab manual, courier booking |
| Equipment | Required equipment is available, calibrated and logged. | Calibration certificates |
| Site file | Investigator site file structure set up; essential documents in place. | ISF index |
| Monitoring and oversight | Monitoring plan and frequency shared; contact points known. | Monitoring plan |
| Deviations and notes | How deviations and notes to file are handled is understood. | See the note to file template |
| Data protection | Participant data handled per protocol and local data protection rules; identifiers segregated. | Privacy documentation |
| Close of visit | Open items logged with owners and dates; decision on readiness recorded. | Action log, signed report |
Add or remove rows to fit your protocol. Rows are prompts for evidence, not guarantees of compliance; the sponsor SOP and local rules decide.
Before the visit, set up the study in the free sandbox so coordinators can enter demo data, trigger a query and see their role, instead of learning the system on day one.
Worked example
After the visit, every open item goes into one log. Here is a short example for an imaginary site. Names and numbers are invented.
| # | Open item | Owner | Due | Blocks start? |
|---|---|---|---|---|
| 1 | Start temperature log for the investigational product fridge and send first week to monitor | Pharmacist | +3 days | Yes |
| 2 | Add start dates for two sub-investigators to the delegation log | Coordinator | +2 days | Yes |
| 3 | Create EDC accounts for the remaining two coordinators | Study manager | +2 days | Yes |
| 4 | Confirm courier pick-up days for central lab samples | Lab lead | +5 days | No |
| 5 | File training attendance sheet and certificates | Coordinator | +3 days | No |
| 6 | Send follow-up letter summarising the visit and open items | Monitor | +5 days | No |
The site is cleared to start when every item marked "Blocks start" is closed and the sponsor confirms in writing. Keep the confirmation in the site file.
After the visit
Record who attended, what was covered, what was checked, and what is open. Use the same template for every site.
List the action items with owners and due dates, and say plainly which ones block the start.
Keep a single log. Verify closure with evidence, not a promise.
The sponsor or study lead confirms that the site may screen. File the confirmation with the report.
Attendance sheet, agenda, training materials, checklist, report, follow-up letter, and activation confirmation in the site file and the trial master file. See how to set up a trial master file.
Use the open items and the first enrolments to decide when. See the monitoring visit report template.
In Capture
Capture is an all-in-one clinical trial platform, so the study the site will use can be built and tested before the initiation visit. Roles separate researchers from site coordinators; a separate site coordinator portal keeps a site working in its own space; and the blank eCRF PDF export gives you a printed set of every approved form for the training pack. You can also upload a protocol and let the AI study builder draft visits and forms, which a person reviews before anything is saved.
Study owner
Builds and configures the study
Principal investigator
Oversees the site, signs off the casebook
Sub-investigator
Enters and signs clinical data
Study coordinator
Screens subjects, enters visit data
Monitor (CRA)
Verifies data, raises queries
Data manager
Reviews, freezes and locks data
Participant
Completes their own questionnaires
Common problems
The recurring problems are mundane. Key staff cannot attend, so they are trained second-hand and no one records it. The delegation log is signed on the day, in a hurry, with dates missing. The investigational product arrives before the storage is ready. User accounts are requested late, so coordinators see the system for the first time at the visit. Documents are filed in the wrong place or not at all. And the visit ends without a written decision on whether the site can start.
Each has a simple prevention: a pre-visit checklist two weeks ahead, a rule that anyone who misses training is trained and recorded separately before they work, a storage check before shipment, accounts requested at contract signature, and a signed activation statement. When a problem still happens, record it plainly; the note to file template is the right tool for the explanation, and the protocol deviation tracking guide for anything that touches the protocol.
A site initiation visit is the meeting, on site or remote, where the sponsor or study team confirms that a site is trained, equipped and documented before it screens its first participant. It covers the protocol, procedures, systems, product handling and the site file.
The principal investigator, sub-investigators, study coordinator, research nurses, pharmacist, lab lead and data entry staff, plus the sponsor representative or monitor. Anyone who will perform a delegated task should attend or be trained and recorded separately.
Often half a day to a day, depending on the complexity of the protocol and systems. The sample agenda here is a half-day. Remote visits are sometimes split across several shorter sessions.
Often yes, especially for small or decentralised studies, if the sponsor agrees. Physical checks such as storage or equipment can be done by video, and training by screen share. Document the format and what was verified.
Approvals, signed contract, CVs and training certificates, the delegation log, the consent form versions, the site file structure and any supply or system access confirmations. The pre-visit checklist on this page lists them.
ICH E6 describes investigator responsibilities such as adequate resources, qualified staff and training, and sponsor monitoring duties, but whether an initiation visit is required and in what form is set by the sponsor monitoring plan and local rules. Check the current guideline text and your plan.
The initiation visit happens before enrolment and focuses on readiness, training and set-up. Monitoring visits happen during the study and focus on data, consent, safety and compliance. The documents differ, though both end with an action log.
The sponsor, or the study lead for an investigator-initiated study, usually confirms activation in writing once approvals are in place and blocking actions are closed. File that confirmation with the visit report.
Keep exploring
Monitoring visit report template
The visits that follow.
Delegation log template
Signed before anyone works.
Investigator site file index template
What the file must hold.
Investigator-initiated trial start-up checklist
The whole start-up, not one visit.
Clinical trial study start-up software
Get ready earlier.
Recruitment plan template
What the site will do after activation.
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