A Start-up Readiness Check for Your Site

Part of Human Subjects Protection for Clinical Research Staff: Doing It Right at Your Site.

About 4 minutes. Free, in your language, no account needed.

Why this matters

Most study-start problems are not dramatic. They are small gaps that nobody checked: a consent version that does not match the approval, a person doing a task they are not listed for, a payment that does not match the consent. This lesson pulls the course together into a short readiness check you can run before the first participant is enrolled.

ICH E6(R3) is the international baseline in this course. The US federal regulations (HHS 45 CFR 46, FDA 21 CFR 50 and 56) are taught as the detailed worked example, and passages that name them are US law. Outside the United States, follow your national law and ethics committee requirements. State or local rules may add requirements, and your institution, sponsor and IRB may have their own start-up steps.

What the rules say, in short

No participant should be enrolled before the IRB/IEC issues its documented approval or favorable opinion (ICH E6(R3) section 1.4.6).

Before starting, the investigator should have the IRB/IEC documented approval for the protocol, consent materials, recruitment procedures and other participant information. Submissions may be made by the investigator or institution, or by the sponsor, depending on region (sections 2.4.1, 2.4.2).

A trial is subject to monitoring and auditing by the sponsor, inspection by regulators and review by the IRB/IEC, and the investigator permits this (section 2.3.5). IRB records are accessible to FDA and agency representatives for inspection and copying (45 CFR 46.115(b); 21 CFR 56.115(b)).

Essential records are retained securely by sponsors and investigators for the period required by applicable regulations, and they are available to regulators, monitors, auditors and IRBs/IECs on request (Principle 9.5).

A readiness checklist (CRLN teaching practice, not a regulatory list)

The checklist below is CRLN teaching practice. It is assembled from the points above and from earlier lessons. It is not a regulatory list. Your sponsor, IRB and institution may require more.

  1. IRB approval letter in hand. You have the IRB's documented approval, and you know what it covers: protocol, consent materials and recruitment procedures.
  2. Current consent version in use. The version at the consent desk matches the one the IRB approved. Old copies are removed.
  3. Delegation log signed. Everyone doing study tasks is listed for those tasks and the investigator has signed.
  4. Training records filed. Each person's study-specific training is recorded and easy to find.
  5. Payment schedule matches the consent. What staff say about payment, and what any approved materials say, matches the consent.

Walk the list with the investigator. If any line is "not yet," the first participant waits.

Why records matter at a later date

Everything above has to be findable years later. Records are not only for the study team. Monitors, auditors, regulators and the IRB may ask for them. A tidy file shows what was approved, who did what and when. A messy one raises questions even when the work was done well.

In practice

A coordinator is two days from the first enrollment. She sits with the investigator and goes through the five lines with the actual documents on the table. The approval letter lists the consent version dated in March, but the consent desk has a folder with an earlier version. She removes it. The delegation log is missing one assistant's signature line, and she fixes that. The training record for the new nurse is on a shared drive, so she files a copy in the regulatory binder. First enrollment goes ahead after the investigator signs off.

What this looks like when it goes wrong

A site is eager to start. The IRB approved the protocol but has not yet approved the consent form revision. A coordinator enrolls a participant on the old form "because it is nearly the same." Weeks later the IRB approves the new version with changes. The participant has no signed copy of what the IRB approved. No participant should be enrolled before the IRB issues its documented approval. The site now has an enrollment problem to bring to the investigator and the IRB, and the participant signed a consent that does not match the approved text.

Key takeaways