Qualified, Resourced and Genuinely Available
Part of Principal Investigator (PI) Training: The Investigator's Accountability.
About 4 minutes. Free, in your language, no account needed.
Why this matters
Two of the shortest sub-sections in the guideline cause a disproportionate share of investigator findings. Section 2.1 asks whether you are qualified. Section 2.2 asks whether you have what the trial needs — including time. The second is the one physicians routinely get wrong, because agreeing to a trial takes five minutes and running one takes three years.
Qualified — and able to prove it
Section 2.1 requires the investigator to be qualified by education, training and experience to assume responsibility for the proper conduct of the trial, and to provide evidence of those qualifications.
In practice, the evidence is a small, boring, permanently current set of documents:
- A current, signed and dated curriculum vitae.
- Your medical license or registration, valid for the period of the trial.
- Training records — GCP, the protocol, the systems you will use, and any procedure the protocol requires you to perform personally.
- Anything the applicable regulatory requirements of your country add.
The failure mode is almost never that a physician is unqualified. It is that the file says a CV was signed four years ago and a license expired last March. Set a single annual date on which every investigator and sub-investigator at your site refreshes all of it, and the problem disappears.
Section 2.1 also requires familiarity with the appropriate use of the investigational product, as described in the protocol and the current Investigator's Brochure. "Familiar" is not "have received". When the Brochure is updated mid-trial — and it will be — the update is a document you read, not a document you file.
Resourced — the honest feasibility answer
Section 2.2 is about whether the trial can actually run where you are. Two sub-points do most of the work.
§2.2.1 — participants. You should be able to demonstrate a potential for recruiting the required number of suitable participants within the agreed period. The guideline explicitly contemplates supporting this with retrospective or currently available data. This is the antidote to the most common site failure in clinical research: the enthusiastic estimate.
Do the arithmetic before you sign, not after. Take the last twelve months of your own clinic. Apply the protocol's inclusion criteria, then its exclusion criteria, then a realistic proportion who will consent. The number that survives is your honest estimate. It is nearly always a fraction of the first number that came to mind.
§2.2.2 — time, staff and facilities. You should have sufficient time to properly conduct and complete the trial, and adequate numbers of qualified staff and adequate facilities for its foreseen duration.
"Sufficient time" is a regulatory requirement, not a courtesy. It is the sub-point that quietly underlies supervision findings, late safety reporting and unsigned data. An investigator who cannot find an hour a week for a trial will produce a site that looks fine for six months and then does not.
The time audit nobody does
Before agreeing to a trial, price your own time in it. A reasonable rough model for a site running a moderate interventional study:
| Activity | Realistic investigator time |
|---|---|
| Protocol, Brochure and amendment reading | 3–6 hours at start-up, then 1–2 hours per amendment |
| Eligibility review and sign-off | 15–30 minutes per screened participant |
| Medical review of visits, labs and events | 1–3 hours per week once enrolling |
| Adverse event assessment | 15–45 minutes per event, unpredictable in timing |
| Data review and endorsement at agreed milestones | Several hours per milestone |
| Monitoring visits, audits, inspections | Half a day to a day, several times a year |
None of these is optional and none of them can be moved to a coordinator. If the total does not fit in your week, the correct answer at feasibility is no — or a sub-investigator with real, protected time.
Declining a trial you cannot run is a professional act, not a failure. It is far cheaper than a site closed for non-compliance, and it is the only version of §2.2.2 that is honest.
Key takeaways
- §2.1: qualified by education, training and experience — with current documentary evidence, refreshed on a schedule, not on request.
- Familiarity with the investigational product includes reading Investigator's Brochure updates, not merely filing them.
- §2.2.1: base recruitment estimates on your own historical clinic data, filtered through the actual criteria.
- §2.2.2: "sufficient time" is a regulatory requirement. Do the time audit before signing, and decline what does not fit.