What You Can Delegate and What You Cannot

Part of Principal Investigator (PI) Training: Delegation and Supervision.

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

Why this matters

New investigators ask the question backwards. They ask what they are allowed to hand over. The useful question is the short one: what is left that only I can do? That list is small, it is knowable, and once you know it the rest of delegation becomes ordinary management.

The default is permission

Section 2.3 starts from a permissive position. The investigator may delegate trial-related activities — and the sponsor may support that delegation, for example by arranging a service provider. What the guideline then attaches to the permission are three obligations:

Read as a whole: you may hand out the work, you choose who gets it, you make sure they can do it, and you watch in proportion to what is at stake.

The short list of what stays

Four acts recur through Annex 1 as the investigator's own. They are not a single tidy list in the guideline; they are what is left when you trace each duty to the person the guideline names.

  1. Trial-related medical decisions — §2.7.1(a). Eligibility, causality, expectedness, whether to unblind, whether to withdraw a participant for their own safety. A qualified physician who is an investigator or sub-investigator, and nobody else.
  2. The investigator's confirmation on consent — §2.8.7 and §2.8.8. The signature by the person who conducted the consent discussion attests that the information was accurately explained and that the decision was freely made. Where the protocol or local requirement puts the investigator's signature on the form, it is an attestation, not a countersign.
  3. Review and endorsement of reported data — §2.12.5. You review the data reported from your site and endorse it at milestones agreed with the sponsor.
  4. The decision to accept the protocol, and to deviate from it. Accepting the protocol is your agreement (§2.5.1); a deviation to eliminate an immediate hazard is a medical decision made under §2.5.4.

Everything else — scheduling, consent discussions, phlebotomy, source entry, dispensing, shipping, regulatory submissions, filing — is delegable to someone qualified and informed.

Delegable does not mean gone

The trap is the word "delegated" doing quiet work in a sentence. Consider two versions of the same site.

Site A. The coordinator consents participants. The investigator reads each consent note within a week, checks the version used and initials the review.

Site B. The coordinator consents participants. The investigator sees the file at the monitoring visit.

Both delegated the same task. Site A supervised it (§2.3.2); Site B did not. If a participant is consented on a superseded form, both sites have the same problem, but only one of them will find it in week one rather than month five — and only one of them can show an inspector how it was being looked at.

Delegating to a service provider

Where a service provider performs a trial-related activity at or for your site — a mobile phlebotomy service, a local imaging facility, a home-nursing vendor — the same logic applies. You still decide whether the arrangement is appropriate for your participants (§2.3.1), and the arrangement is documented. A sponsor-arranged vendor is not exempt from your judgment simply because you did not choose it.

If you would not be comfortable defending the arrangement in front of the participant, say so at start-up. That is the moment when it costs nothing.

Key takeaways