What is adequate oversight by the investigator in a clinical trial?

21 Jan What is adequate oversight by the investigator in a clinical trial?

According to GCP addendum 4.2.5: The investigator is responsible for supervising any individual or party to whom the investigator delegates trial-related duties and functions conducted at the trial site.

The question is: How to define an adequate oversight/supervision by the investigator?

When the investigator has agreed to conduct a clinical trial, it commits a lot of responsibilities. The investigator can delegate all practical tasks to the qualified trial staff, but the investigator cannot delegate the responsibility of being investigator.  In other words, the investigator should have sufficient time to properly supervise the clinical trial. The level of supervision should be appropriate to the staff, the nature of the trial and the subject population.

Following factors may require higher level of supervision:

• Inexperienced site staff
• Demanding workload for site staff
• Complex clinical trial (trial design, complex procedure, amount of data etc.)
• Large number of subjects
• Subject population (paediatric, elderly, seriously ill)
• Multiple trials conducted concurrently
• Multiple sites with the same investigator

Examples of oversight/supervision tools:

• Having routine meeting with the site staff and the sponsor monitor
• Having procedures in place (e.g. procedure for timely correction and documentation of problems, procedure for addressing medical and ethical issues arising during the trial)

The level of supervision should be adjusted according to above factors.

PharmaGCP’s Golden Rules “Investigator & Site Staff” contain the most essential rules for how to ensure proper trial conduct – for only 15 Euro; https://pharmagcp.com/golden-rules/