Updated: Jun 3, 2019
This post continues to expand on Investigator responsibilities and this week focuses on GCP 4.1.3 and 4.1.5...
"The Investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements"
How do we ensure this at site, above and beyond the Investigator providing a GCP certificate? Auditors are now asking more frequently for Investigators to demonstrate their awareness and understanding of GCP. In an audit/inspection, some of the correct responses could include that the PI checks all their patients are eligible, that the consent process has been followed and documented, that baseline health status and conmeds are collected, that the PI checks for adverse events at each visit, that essential documents are appropriately maintained in the site file and that the PI has good supervision of all staff on the delegation log (and describe how this is managed). At a site level, it is good practice to have regular meetings where GCP updates and applicable information or noteworthy articles can be supplied to PI's and the meetings minuted to demonstrate this. Sites should have a GCP training policy that describes how GCP training is managed and how often staff should receive GCP training. This policy should be shared with sponsors/CROs as required.
"The Investigator should maintain a list of appropriately qualified persons to whom the Investigator has delegated significant trial-related duties"
This is managed via a delegation of duties log, one of the most important essential documents. At the start of every trial (after GCP training and protocol training), the PI should ensure that all staff who will be involved in the trial sign the trial-specific delegation log. The TransCelerate version of this log can be found in the file section of this website.
The most appropriate time to complete this is immediately after protocol training. Ensure the list of duties on the log has been reviewed and all staff are assigned the appropriate duties and are confident they have the correct training and qualifications to perform that duty. If the duty to be performed is not on the delegation of duties list, use the "other" box and describe the duty clearly.
Everyone on the delegation of duties should have appropriate GCP training, provide a CV for the site file, and a position description should also be made available during audit/inspection. The log must be kept current and up to date - it is not acceptable for a member of the trials team to sign on to the delegation log and for the PI to sign off the new staff member on the delegation log weeks or months later - this does not demonstrate good PI supervision and would be classed as a serious finding. Ensure new staff sign on to the log and staff leaving sign off on their last day working on the trial and ensure copies are sent to the sponsor/CRO. Never destroy any version of the delegation log. The delegation log must always be signed by the PI