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Hosting Study Audits and Inspections SOP Considerations

When you are creating SOPs for hosting a study audit and/or inspection, keep in mind the following:

  • Sponsor and/or sponsor representative contact will be made immediately upon notification of regulatory inspection.
  • Agree on dates and obtain the name(s) and contact information of the auditor/Inspectors
  • Clarify the roles and responsibilities of the site staff, PAREXEL and Sponsor representatives for the inspection
  • A liaison/host will be designated to facilitate the audit and communicate directly with the regulatory inspector prior to the designated audit date (if possible).  The liaison/host will take primary role in interacting with the Inspector (escorting, handling requests and obtaining answers)
  • A private conference room will be reserved, if available, for auditor/inspector to conduct their required review. It needs to be ensured that no materials related to any other study is present in the room.
  • Upon receiving a notification from the auditor/inspector, the Principal Investigator or his/her designee will make all requested study-related documents available.
  • The Principal Investigator and other pertinent staff will be available during the audit/inspection.
  • The Principal Investigator or his/her designee will greet the auditor(s).
  • The Principal Investigator or his/her designee will greet the regulatory inspector(s) and verify identification/credentials. 
  • The liaison will:
  • Provide requested documents, ensure any subject personal identifiers are removed
  •  Accompany auditor(s)/inspector(s) during tours and interviews
  • Maintain a list of questions asked that require consultation with staff not readily available to answer.
  • Maintain a list of documents requested.
  • Maintain a list of documents copied.
  • Assist the inspector(s) as needed.
  • Arrange for a debriefing at the conclusion of the audit/inspection.
  • Arrange follow-up if required.
    • If the regulatory inspector provides the Principal Investigator with a response to the audit in, the Principal Investigator will prepare a written response to any observations noted and send the response to the agency within the appropriate time. The written response will include:
  • Adequate responses to each observation and explanation of what steps have been taken or will be taken to remedy the observation and prevent future occurrences. Timelines for completion will be included.
  • Responses that are factual and cooperative (in tone)
  • The site should as applicable involve/ consult with PAREXEL/ Sponsor for support in compiling responses and share the final responses submitted including follow-up
  • All sponsor audit observations should be responded to as discussed during the closeout meeting with the auditor(s).