Dear TACL T2016-002 Study Investigator:
As investigators participating in a clinical trial using the investigational medicinal product (IMP) nivolumab, Bristol-Myers Squib has issued safety reports referenced in the memos found below. The details of these adverse events/safety issues can be found in the "Detailed Individual SUSAR/CIOMS Report" page. Each safety report has been independently reviewed and assessed by Dr. Anupam Verma (TACL Study Chair) and/or Dr. Nobuko Hijiya and Dr. Deepa Bhojwani (Vice-Chairs) for T2016-002 study.
WHAT THE INVESTIGATOR NEEDS TO DO WITH THIS INFORMATION:
- Review each external adverse event associated with the use of Nivolumab as described in the T2016-002 Nivolumab External SUSAR summary report independent of study chair's determination
- Evaluate each external adverse event to determine if it meets your local IRB/IEC reporting requirements
- If Iocal IRB/IEC reporting requirements are met, submit it within the required timeframe
- Even if local IRB/IEC reporting requirements are not met, submission may be necessary per TACL Study Chair's determination
- Copy and attach the summary reports to your Investigator's Brochure for the T2016-002 Nivolumab study protocol
- Retain a copy of the memos in your site's study regulatory files