Site Initiation and Study Start-up
The site initiation visit (SIV) converts a selected site into an enrolling site. No study activity - screening, consenting or IP receipt - may occur until the required pre-requisites are in place: written IRB/IEC approval of the current protocol and consent, executed contract, complete regulatory documents, and trained staff.
The SIV agenda a CRA must own
- Confirm protocol understanding: eligibility, visit windows, endpoints, prohibited medications, discontinuation criteria, AE/SAE definitions and reporting timelines.
- Review source documentation expectations and CRF/EDC completion rules.
- Train on investigational product: receipt, storage temperature range, dispensing, kit assignment, emergency unblinding, accountability records.
- Establish or verify the delegation of authority log (E6 4.1.5) so each task is assigned to a named, qualified, trained person; obtain dated signatures.
- Confirm the regulatory binder contents and the site's process for filing amendments and correspondence.
- Record all training with attendee name, signature, date, and topic - undocumented training is treated as absent.
Traps
- Assuming IRB approval and contract execution are simultaneous; either gap blocks enrolment.
- Accepting blank or pre-signed delegation logs. Pre-signing destroys the credibility of the entire log.
- Missing protocol amendment training: new procedures cannot be implemented until the amendment is approved and staff are trained, with documentation.
- Confusing the sponsor's signature on the protocol with the investigator's signature page acknowledging the agreement.
Rule of thumb: every entry in the delegation log should be answerable with a matching CV, training record, and (where required) licence. If the SIV report leaves actions open, track them in a follow-up letter with owners and due dates rather than relying on memory.