What You Answer For in Investigational Product

Part of Principal Investigator (PI) Training: Investigational Product Decisions.

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

Why this matters

The GCP course teaches §2.10 in full and you should read it there. This lesson answers a different question: at a site where a pharmacist stores the drug, a coordinator dispenses it and a nurse administers it, what is left that is yours?

The answer is more than most physicians expect, and it is the part that shows up in findings.

The delegation is explicit, and so is the supervision

Section 2.10.1 makes the investigator responsible for investigational product management at the site. Section 2.10.2 then permits delegation to an appropriately qualified person — a pharmacist, typically — under the investigator's supervision, with the sponsor able to facilitate the arrangement.

That is the same structure as everywhere else in this course, and it has the same consequence. A hospital pharmacy running the product to its own excellent standards is not a reason to stop looking. It is a delegation you supervise, proportionate to risk (§2.3.2) — and investigational product is high risk by definition, because the whole point is that its effects are not fully known.

The four things that stay with you

The decision to give it to this person, today. Every dose is given on your authority under the protocol. Eligibility, the dose, whether today's clinical picture still supports dosing — those are trial-related medical decisions under §2.7.1(a).

Use in accordance with the protocol. Section 2.10.6. Not the label, not usual practice, not what worked for the last participant — the protocol.

That the participant knows how to use it, and that someone checks. Section 2.10.7 requires the correct use to be explained to each participant and their use and compliance checked at intervals appropriate for the trial. For anything self-administered at home this is a real clinical task, not a handover of a bag.

That the numbers reconcile. Section 2.10.3 requires documentation of delivery, inventory, dispensing, use, and disposal or return. You do not count the tablets. You are answerable for whether the count is right, which means somebody reconciles and you know they did.

The reconciliation habit

Accountability findings are among the most common at sites and they are almost always arithmetic, not misconduct. The cheapest control is a periodic three-way check, done by someone and reviewed by you:

The three must agree, and where they do not there must be an explanation written at the time. Doing this monthly turns a year-end catastrophe into a five-minute discrepancy that someone still remembers.

Two specifics worth naming, because they are where the numbers usually break: product returned by a participant and quietly restocked, and product dispensed for a visit that then did not happen.

Home-administered and shipped product

Section 2.10.8 contemplates product being shipped to or near the participant's location and administered there by a qualified individual or by the participant. Where your trial does this, three questions belong to you before the first shipment:

If the answers are not written down at start-up, the site will improvise them during the first incident.

Key takeaways