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JOIN US FOR The Online Webinar "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. 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. 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
  • Start:July 06, 2021
  • End:July 06, 2021
  • Recurring
  • Where:New York, New York,, New York County, New York, United States, 10000
  • Phone:N/A
  • Event Type: Other
  • Ticket Price:N/A
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