Updated: Jul 2, 2021
This post continues with investigator responsibilities in GCP 4.2.5: "The Investigator is responsible for supervising any individual or party to whom the investigator delegates study tasks conducted at the trial site"
This is an addendum that was published in the E6 R2 updates in 2017. The previous wording had been investigator "oversight" and this has now changed to investigator "supervision", which is a significant change that sites and PI's need to be aware of. But how do we ensure this is being demonstrated at site? There are a number of ways in which this can be supported...
Set up a group email that reflects the delegation log and update it if the delegation log changes. If a PI has a group email setting that allows him/her to easily communicate with the whole team, it can encourage better ways of staying in touch with the team and more easily keeping the team up to date. Study coordinators can assist by sending PIs information they can send out to the rest of the team as required.
Set regular meeting times between the PI and study team - this could be a regular 15 minute meeting each week, but ensure it is something that the PI can and will stick to. During the regular meetings, discuss current and new patients, AEs, any upcoming protocol changes etc. Minute each meeting and ensure the PI signs and dates after each meeting
Ensure the PI is always involved in the training of all staff at the beginning of a trial and when new staff join the trial - this can be as detailed as attending/organising the training or as simple as emailing out slides and training material.
Keep the delegation log up to date at all times. Ensure the PI is always present when new staff join and are signed on to the log - never leave a gap between the date a new team member joins and the date the PI signs
Ensure the PI documents the eligibility of each new patient or that this duty is also delegated to other Sub-Investigators who keep eligibility records of all patients up to date at all times
Ensure the PI is able to demonstrate and document supervision of Sub-Investigators via regular meetings and communication. This could happen at normal MDTs, ward rounds, clinic meetings etc.
Consider an SOP that details how the PI has supervision of their team if your organisation has regular processes/meetings that support this and ensure you have documentation to support these processes.