Inspection Readiness – Execute and Monitor


Lesson Code: CIR-802 (PREMIUM LESSON). Provides practical techniques and strategies for the Execute and Monitor phase of a Good Clinical Practice (GCP) Inspection using project management principles.


  • Category: GCP Inspection Readiness

Description

Skillpad's GCP Inspection Readiness suite is presented in a series of 4 e-Lessons built to help you prepare for a Clinical Trial Inspection at a Pharmaceutical or Biotech company.  The e-Lessons are designed using an immersive real-world scenario, written by Skillpad's Compliance Subject Matter Experts, where you are the Project Manager in charge of the Clinical Trial Inspection Project.  

Intended audience:  Everyone participating in a Clinical Trial Regulatory Inspection.  Emphasis on the Project Manager's coordination role, but extremely useful for all other members of the team.

Pre-requisites:  Basic knowledge of GCP and regulatory inspections.  Note: This is the third e-Lesson in a series of 4.  Although this e-Lesson can be taken as a standalone, the trainee will get the maximum benefit if they have already taken the first two e-Lessons in the series (CIR-800 and CIR-801)

PART 3: EXECUTE & MONITOR

The third of the 4-part series, this e-Lesson takes you through the "Execute & Monitor" phase of Project Management for the Clinical Trial Inspection Project, where you will focus on these key tasks:

1. Known Issues: you and the Core Project Team will discuss the known issues and potential issues that will be areas of interest to the Inspector, including: Change Control, Deviations, Corrective and Preventive Actions, and Study Management.

2. Questions and Responses: you and the Team will prepare a list of standard questions to which you must write the responses.  The responses must be practised by the Core Team to ensure professionalism and consistency are displayed and your Company understands its product and all the issues. 

SPECIAL RESOURCEa list of typical questions asked by GCP Regulatory Inspectors is available in this e-Lesson's "Resource" tab to help your Core Team prepare for this task.

3. Key Documents: Ensure the following documents are ready for Inspector review and available during the Inspection: Study Storyboard, Inspection Checklist, Organizational Chart, Transfer of Obligations to CRO.

4. Execute Individual Responsibilities:  During the Inspection, each Team Member must execute their responsibilities.  They must be at the Inspection Kickoff Meeting with the Inspector, and play their parts as planned.  They must also take part in the daily debriefing meeting, and pass on any issues that need to be escalated.

5. Monitor:  The Inspection Project Manager is the focus of this section, and he or she must monitor the progress of the Inspection, ensure the daily meetings take place, issues are properly escalated and resolved, and that the correct documentation is given to the Inspector when required.  The other Core Team members should be aware who is responsible for this function and provide support as needed.


After completing this e-Lesson, you are ready to take CIR-803 "Inspection Readiness: Close"