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The January 17, 2008, CRC meeting addressed vital concerns in adverse event (AE) reporting, highlighting confusion over IRB and sponsor requirements, severity classifications, and tracking of non-local events. Key updates included changes in AE reporting processes, a call for electronic submissions, and clarification on when to use AE forms. Best practices emphasize timely reporting to ensure human subject protection, with a focus on regular data submissions. The meeting encouraged feedback on ERSA updates to streamline compliance and communication in clinical research.
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Adverse Event Reporting Serelda Young, RN, CCRC Corporate Integrity Karen Marie Sorapuru, CIP IRB Administrator CRC Meeting January 17, 2008
Concerns identified at the CRC meeting • IRB requirements versus sponsor requirements • Generalized confusion regarding the reporting of local and non-local events • Confusion regarding severity, relatedness and unexpectedness • Inconsistency with PIs determining severity, relatedness and unexpectedness • Necessity of electronic copies for IRB submission • Confusion about when to use the AE form and when to use the AE log • Inability to track the submission of non-local events without submitting them individually
Adverse Event Reporting • Individual Policies • Internal Events • External Events
IRB wants only local SAEs Sponsors want IRB Acknowledgement for each Non-local SAE
Clinical Research • Sponsors are responsible for the success of the individual clinical trials. • The IRB is responsible for Human Subject Protection. • CRCs are responsible for everything!”
External Event Management • Responsible Party= Sponsor • Best Practice = regular submission of Data Monitoring Committee Reports • Exception = an event that increases the human subject riskfor participating in a trial must be reported to everyone involved
Institutional Changes • Individual policies for internal and external adverse event reporting • IRB Memo to sponsors • Changes to the ERSAsystem
Overview of ERSA Updates • Submission types for Reportable Events • Added Adverse Event Report Log • Order of options has been changed • Examples or explanations added to better define options • With new options are new corresponding pages
Application Page Updates • Adverse Event Log • New Option • Used if Sponsor, despite our best efforts, are still insisting that you submit ALL external event reports • Updated Log • Can be found in the Forms and Templates folder on ERSA home page (IND Report Log) • No longer asks the local PI to make any determinations regarding relatedness, severity, etc. • Contains a text box that will populate to the acknowledgment letter
Application Page Updates • External SAE • Option now explains “…only one [report] per application” • IRB Staff will return applications with more than one report attached • Effective today, January 17, 2008 • Note at the top of the application page now states: • “As of 1/17/2008, this application form should only be used if the event being reported is deemed [by the Sponsor] to have a direct link to the test article that is so important that everyone must be notified immediately.”
What’s Next? • Acknowledgment templates will be updated • System notifications of acknowledged reportable events will be activated • Continuing review applications will be updated • To accommodate the current SAE reporting requirements and to clarify what those numbers include • To attach DSMB reports • The IRB/CRC Meeting (Monday-January 21-10:00 am- Tyrone Room) will be dedicated to hearing your suggestions and requests concerning ERSA updates.
