COURSE DESCRIPTION
OVERVIEW
Most pharmaceutical and biotech companies (sponsors) outsource the management and conduct of their clinical trials to a Contract Research Organization (CRO). Although sponsors can delegate tasks to a CRO, they continue to be responsible for subjects’ safety and overall trial compliance to regulatory requirements. This is a difficult task under normal circumstances, but seemingly impossible under current COVID-19 travel restrictions. Even with this challenge, global health authorities will still expect sponsors to have complete and uninterrupted oversight of their CRO partners.
The ultimate question remains: How does a sponsor provide rigorous oversight to ensure protection of subjects’ rights and safety?
This web based training will provide participants with tips and best practices for a conducting a virtual audit of a CRO to determine compliance to Good Clinical Practice (GCP) requirements, study protocols, and CRO/sponsor contractual agreements.
Specifically, this course will cover:
- Steps in Preparing for the Audit
- Deciding what & when to audit
- Set-up Infrastructure (Sponsor & CRO)
- Properly scheduling the audit
- Steps in Conducting the Audit
- Introductions and meetings
- Documentation to review
- Questions to Ask
- Compilation and grading of observations
- Assessment of
- Risk to Subject safety and/or study integrity
- Compliance to GCP/SOP/ Contract(s)
- The Audit debrief
- What to say
- What NOT to say
- The Audit Report
- Follow-up activities
- Audit closure
- Certificate and File
LEARNING OBJECTIVES
At completion of this training, participants will have a working knowledge of the process for auditing a CRO to determine compliance to GCP and their contractual agreements with the sponsor. This includes…
- Examining best practices for preparing for a remote audit
- Executing steps for conducting a remote audit
- The audit debrief – what to say, and what not to say
- Exploring the proper authoring of an audit report
- Follow-up activities
- Audit closure
There are no reviews yet.