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 risk for 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 ERSA system

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.