Webinars >>Clinical Protocols
How to Make Efficient FDA-Compliant Clinical Protocol Amendments

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. Surveys have shown that each protocol amendment costs anywhere from $72,000 to as much $500,000 adding to the study budget and causing delays. However, protocol amendments increase the odds of successful completion of a given clinical trial, and increase the probability of getting the desired outcome. Sponsors and clinical project teams must create rules for when a protocol must be amended, and the best practices to create and implement an FDA-acceptable protocol amendment.

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Why should you attend:
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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. The session will highlight key regulatory requirements, dos and don’ts, common areas of concern, and trouble-shooting practices for clinical project teams using case studies and examples from the presenter’s vast experience helping large and small clinical trials in dealing with deviations, safety issues, and operational limitations that lead to protocol amendment. The webinar will provide tips for deciding when an amendment is necessary, the best practices for creating and implementing a protocol amendment without disrupting the study. Amendment to conventional, adaptive design, compassionate-use, and investigator-led clinical studies will be discussed with suggestions from a FDA-acceptance perspective. The seminar is designed to provide a well-rounded training to all stakeholders in all aspects of the creating and implementation of clinical protocol amendment.
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 
Who will benefit:
  • Clinical research associates
  • Clinical project managers
  • Medical writers
  • Sponsors
  • Regulatory affairs personnel
  • Quality assurance personnel
  • Vice presidents, Directors and Managers
  • People interested in investing in the FDA-regulated industry
Date: August 22, 2024
​Duration: ​60 Minutes
​Time: 12 PM EST

Speaker
Mukesh Kumar, PhD, RAC, Brij Strategic Consultations, USA
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For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: [email protected]