What You Are Personally Accountable For

Part of Principal Investigator (PI) Training: The Investigator's Accountability.

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

Why this matters

Most physicians arrive at their first trial having already run a clinic, a ward or an operating list. You know how to be responsible for patients. What is new is being responsible for a process — one that other people execute, that a sponsor pays for, and that a regulator can reconstruct years later from paper.

This course is not a GCP course. CRLN's GCP course already teaches the guideline. This one teaches the part of the guideline that has your name on it and cannot be handed to anyone else.

The one sentence that organizes everything

ICH E6(R3) permits you to delegate almost any task at your site. It does not permit you to delegate responsibility for it. Principle 10.1 states the rule directly: parties may delegate activities, but responsibility for the trial always resides with the sponsor or investigator, as applicable.

Everything in this course follows from that split. A coordinator can consent a participant. You remain responsible for the adequacy of that consent. A pharmacist can dispense the investigational product. You remain responsible for its accountability at your site. A nurse can record vital signs. You remain responsible for whether the record is adequate.

Delegation moves the hands. It does not move the name.

Who "the investigator" actually is

The guideline's Glossary is precise, and the precision matters at inspection.

• Investigator — the person responsible for the conduct of the trial at a trial site. Where a trial is run by a team at a site, the investigator is the responsible leader of that team and may be called the principal investigator.
• Sub-investigator — a member of the trial team designated and supervised by the investigator to perform trial-related procedures and make trial-related decisions. The guideline's own examples include associates, residents and research fellows.
• Investigator site — the location where trial-related activities are conducted.

Read those together and the structure appears. There is one responsible leader. Everyone else at the site, however senior, however experienced, acts under that leader's supervision for the purposes of this trial.

The four things that are yours alone

Across the whole of Annex 1 section 2, four categories keep returning to you personally. They form the spine of this course.

1. Oversight. You decide who is fit to do each task, you make sure they are informed, and you supervise them in proportion to the risk (§2.3). Modules 2 and 3.
2. The medical decisions. Eligibility, causality, expectedness, whether to unblind, whether to withdraw someone for their own benefit. A qualified physician who is an investigator or sub-investigator is responsible for trial-related medical decisions (§2.7.1). Modules 4, 6, 7 and 8.
3. The consent, in substance. Not the signature-gathering, which you may delegate, but whether the person genuinely understood and freely agreed. Module 5.
4. The record. The data reported from your site is data you have reviewed and endorsed (§2.12.3, §2.12.5). Modules 9 and 10.

What this is not

It is not a promise that you will do all of it yourself. A well-run site is one where a trained team does the work and the investigator knows, at any moment, enough to answer for it. The skill this course teaches is oversight: how to build a site where you can honestly say "yes, I know that was done properly, and here is how I know".

An investigator who does everything personally has usually just built a bottleneck. An investigator who does nothing personally has usually just built a finding.

Key takeaways

• Tasks are delegable; responsibility is not. Principle 10.1 is the sentence the rest of the guideline hangs from.
• The Glossary gives one responsible leader per site. Sub-investigators act under your supervision, whatever their seniority.
• Four things stay with you: oversight, the medical decisions, the substance of consent, and the record.
• Good oversight is not doing the work yourself. It is being able to show how you know the work was done properly.