Updated: Apr 8, 2022
This post continues further with Investigator responsibilities and this week focuses on GCP 4.2.2
The Investigator should have sufficient time to properly conduct and complete the trial within the agreed trial period.
How can this be accurately assessed at site level to demonstrate appropriate and safe capacity to take on new trials to Sponsors and CROs? One method is to apply a risk assessment criteria to all current trials - rather than assessing just how many trials a PI is leading, the trials can be broken down into a portfolio of high, low and minimal risk trials.
A Unit can then make more accurate decisions with their PIs around the risk ratio of their trial portfolios - if a PI already has 50% of their clinical trials classified as high risk, 30% as moderate risk and 20% as low risk, it may be more appropriate to look to take on more moderate to low risk studies rather than more high risk studies at that time. This can also be balanced against trial unit staffing and experience, current and future staff leave etc. An example of a risk assessment tool is available for download in the file share page.
A PI must ensure they understand that when they agree to do a clinical trial, they must be able to make themselves available to monitors, auditors etc as requested and that they should have adequate time to meet with their trials team, trials pharmacist and keep patient safety as a priority. Sponsors and CROs will expect to see this demonstrated and documented.
Ensure the recruitment period is clearly considered when reviewing the Clinical Trial Research Agreement (CTRA) and that both the PI and the trials team are confident that the patient recruitment target is achievable within the timeline stated in the CTRA.