Investigator, Staff and Ethics Documents

Part of Clinical Research Associate (CRA) Training: Regulatory Documents and the Site File.

About 6 minutes. Free, in your language, no account needed.

Why this matters

Essential records are how a trial can be reconstructed and its quality judged. This module covers what a site must hold; this lesson covers the two categories that generate the most findings — the people, and the ethics committee.

The term is now "essential records"

ICH E6(R2) said "essential documents". E6(R3) says essential records, and the change matters: records include data and relevant metadata, such as audit trails, not only signed paper.

E6(R3) Appendix C lists them and sets the handling rules. Two features are worth knowing.

The list is risk-proportionate. Appendix C frames its table conditionally: if these records are produced, they are essential and should be retained. A record a trial never generated is not missing. The site must be able to explain why it does not exist, which is a different question.

"Investigator site file" is a permitted name, not a requirement. Appendix C says essential records should be held in repositories by the sponsor and by the investigator or institution, and that these may be referred to as a trial master file and an investigator site file. Do not write a finding against a site because it calls its file something else.

Investigator and staff documents

Curricula vitae

Purpose: evidence that the investigator and key staff are qualified for their roles.

Requirements: signed and dated. Updated when experience changes materially, or on the sponsor's schedule.

What you check: that a current CV exists for every person on the delegation log; that it is signed and dated; and that it actually supports the role the person performs.

Medical licenses and professional registrations

Purpose: confirmation that investigators and sub-investigators are licensed to practice.

What you check: current validity in the region of practice, and expiry dates, at every monitoring visit. Escalate a license that has expired or is close to expiry. An expired license during a period when the person performed trial tasks is a serious finding.

Good Clinical Practice training certificates

Purpose: evidence that delegated staff have completed GCP training.

What you check: that every person on the delegation log has current training; that it reflects the applicable standard, which today means ICH E6(R3); and that new staff completed it before performing study tasks.

Renewal intervals such as two or three years come from sponsor or institutional policy, not from ICH. Say so accurately when a site asks.

The delegation of authority log

Purpose: documenting who is authorized to perform each trial task.

Requirements: complete, signed by the investigator, dated, with start and end dates for each person, and updated as staff join and leave.

What you check — and this is the highest-yield check in this lesson: take entries from source records, consent forms and the data system, find the initials, and test them against the log. Was that person delegated for that task on that date? Were they trained by then?

The commonest failures are staff working before being added, leavers never given an end date, and tasks appearing in the records that nobody was delegated to perform.

Financial disclosure forms

Where required, confirming investigators' financial interests so that conflicts can be assessed. Check that all investigators have completed them and that updated forms are filed when staff change.

Ethics committee documents

Approvals

The site must hold written approval for the protocol and each amendment; each consent form version; any advertisements or recruitment materials; and, where required, the Investigator's Brochure and other site-facing material.

What you check: that no study procedure occurred before the relevant approval; that the versions in use are the approved ones; and that the approval dates precede the site's implementation dates.

Correspondence and continuing review

Acknowledgments, safety letter receipts, continuing review approvals, annual updates, and any conditions attached to an approval.

What you check: that continuing review submissions were made on time and that approval has not lapsed. A lapse means study activity must stop until it is restored, so this is checked at every visit, not annually.

Committee membership lists

Some sponsors require a roster to evidence that the committee is constituted appropriately. Where required, check that it is filed and consistent with the approval letters.

In practice

At a VT-301 site, Leah takes six consent forms at random and checks the signature of the person who conducted each discussion against the delegation log.

Five are fine. The sixth is signed by a nurse whose delegation start date is two weeks after the consent date.

The coordinator explains that the nurse had been working at the site for months and was simply added to the log late, when someone noticed the omission.

Leah does not accept that the date can be corrected. The log says what it says, and altering it would be far worse than the original gap. She classifies it as a major deviation: consent obtained by a person not delegated at the time.

The investigator reviews the participant's records, and the site reports the deviation. The corrective action addresses the cause: the site had no step in its onboarding that added a person to the log before they worked on the study. That step now exists, and Leah verifies it at the next visit.

The nurse was competent. The record could not show she was authorized, and that is the finding.

Key takeaways