Presenters Madeleine Williams and Roberta Costello answer attendee questions following their recent webinar “How to Prepare for an FDA Inspection.” In this article, the presenters address audit topics such as Good Clinical Practice, Principal Investigator (PI) availability, PI oversight and more.
Does the Principal Investigator (PI) have to be 100% available for the whole duration of the audit?
As part of the initial discussion with the Inspector, the timing/duration of the PI’s presence during the inspection should be established. Inspectors understand that PIs have obligations and it has been our experience that they will do their best to work out a schedule agreeable to everyone.
When an inspection is announced, the PI should do what they can to make their schedule as flexible as possible during the time of the inspection. The PI should plan to be available for the introductory meeting, meetings during the course of the inspection and the close out meeting.
Do all staff members need to have Good Clinical Practice (GCP) and Human Subject Protection Training (HSP)?
The FDA has an expectation that the study team has knowledge of the applicable human subject regulations and of investigator responsibilities. The regulations do not specifically state that all staff members need to have GCP and HSP training, however, most institutions have internal GCP and HSP training requirements that must be met prior to conducting human subjects research.
To verify that training expectations are met, you must be aware of your institution’s policy related to training and also that of the sponsor. Before initiating a study, have the study sponsor clearly define sponsor training requirements and review your institution’s policy related to training requirements. Be sure to maintain all training certificates for the duration of the study.
The FDA’s Guidance for Industry Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects (October 2009) offers detailed information on supervision of the conduct of a clinical investigation and explains adequate supervision and training. This document can be found at: http://www.fda.gov/downloads/Drugs/…/Guidances/UCM187772.pdf
What are some tips for clearly showing PI oversight of a study?
There is no one right way to document PI oversight. Ideally, a discussion with the study team and the sponsor should be held to identify acceptable methods for achieving this. Here are some ideas that may help you identify methods to incorporate into your practice:
- Have the PI initial/date when reviewing study specific tests/procedures, adverse events, etc.
- Summarize informal communications with the PI related to the study in an email that goes to the PI and the study team
- Keep minutes of study team meetings.
What are some ‘quick tips’ for preparing for an inspection?
- Be familiar with the regulations and protocol guidelines that apply to the studies you are responsible for. Inspectors are looking to confirm that you are complying with the applicable regulations and study procedures.
- Know the scope of your responsibilities and know which members of the team are responsible for specified study activities.
- Be familiar with not only the regulatory definitions of Serious Adverse Events/Adverse Events and the required actions, but also protocol specific definitions. Be sure you are complying with requirements of the regulations and the protocol.
- Keep your study files in a ‘ready state’ at all times.
- Periodically review study materials for accuracy and completeness. Pay particular attention to items that may be required to be updated during the course of a study such as the Delegation of Authority log, study team licenses, training and CVs. Remember, keep all versions of documents throughout the course of the study. Do not discard outdated documents.
- Share what you learn and your experience with others.