Question 9 of 20 Fundamentals Concept
Why can an investigator delegate trial tasks but not responsibility?
Short answer
The investigator may hand tasks to qualified, trained staff or service providers, but keeps ultimate responsibility for participants' safety and the reliability of the data. Delegation therefore needs a record of who does what, proof of qualification and training, and real supervision.
Why
One person can rarely do every visit, sample and assessment, so delegation is normal. GCP ties it to accountability. E6(R3) section 2.3 says the investigator retains ultimate responsibility and should oversee delegated work in proportion to its importance.
The investigator keeps a record of the people and parties given trial activities. FDA guidance on investigator responsibilities makes the same point and lists tasks that inspectors have found delegated to unqualified staff: screening and eligibility checks, physical examinations, adverse event evaluation, primary endpoint assessments and obtaining consent. If the protocol says a physician performs an examination, a physician must do it, even if local law would allow a nurse practitioner.
Medical decisions always rest with a qualified physician or dentist. The record matters at inspection, because a delegation log that lists a coordinator for 'all tasks' shows no thought about competence. E6(R3) adds that routine clinical care done as normal practice may not need delegation documentation.
A strong answer covers
- Ultimate responsibility stays with the investigator
- Delegation record naming tasks, not blanket roles
- Qualification, training and licensure matched to each task
- Oversight proportionate to risk and data importance
- Protocol qualification requirements override local scope of practice
Common mistakes
- Treating a signed delegation log as proof of supervision.
- Delegating eligibility decisions or adverse event causality to staff without medical training.
- Forgetting to add new staff to the log before they start trial work.
The interviewer might ask next
How would you show an inspector that you actually supervised a delegated task?