Adverse Event Reporting

1. Adverse Event Reporting Serelda Young, RN, CCRC Corporate Integrity Karen Marie Sorapuru, CIP IRB Administrator CRC Meeting January 17, 2008

2. 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

3. Adverse Event Reporting • Individual Policies • Internal Events • External Events

4. EXTERNAL ONLY!

5. IRB wants only local SAEs Sponsors want IRB Acknowledgement for each Non-local SAE

6. 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!”

7. 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

8. Institutional Changes • Individual policies for internal and external adverse event reporting • IRB Memo to sponsors • Changes to the ERSAsystem

9. 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

10. 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

11. 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.”

12. 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.