Live Webinar: "How to Make Efficient FDA-Compliant Clinical Protocol Amendments" When: Tuesday Jul 6, 2021 - 01:00 PM EST Duration: 60 Minutes.
On an average a clinical protocol gets amended anywhere from 3-6 times after it has been finalized. Most protocol amendments happen for ongoing studies and require re-consenting subjects, and numerous operational and regulatory updates including FDA review and IRB approval prior to implementing an amended clinical protocol. Protocol amendments are not only operationally burdensome; they could also impact the scientific validity of the study, if not appropriately designed or implemented. This webinar, presented by a leading clinical protocol expert will discuss FDA expectations from protocol amendment process, and best practices for avoiding errors and accidents.
Areas Covered in the Session:
Five common reasons for amending a clinical protocol
When a protocol should not be amended
FDA expectations from protocol amendment process
Operational aspects of protocol amendment
Statistical issues that must be considered when amending protocols
Differences between protocols for drugs, biologics and medical devices
Best practices for training and monitoring clinical sites during and after protocol amendment
Common FDA audit findings for improperly amended protocols and potential solutions
Contact Person: SAM