Over the years we have seen some general confusion regarding the use of the FDA MedWatch 7-day report for fatal blood collection or transfusion reporting versus the standard 7-day alert requirement for FDA individual case safety reports from IND trials. Some of the safety systems that our company has worked with over the years do not have a report formedwatch the 7-day IND Alert required in clinical trials of investigational products in the US yet they do have the required MedWatch 7-Day report used in blood collection or transfusion fatality reporting.
The FDA requirements read as follows:
“Telephone and facsimile transmission safety reports. The sponsor shall also notify FDA by telephone or by facsimile transmission of any unexpected fatal or life-threatening experience associated with the use of the drug as soon as possible but in no event later than 7 calendar days after the sponsor’s initial receipt of the information.” (CFR 312.32(2))
“When a complication of blood collection or transfusion is confirmed to be fatal, the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, shall be notified by telephone, facsimile, express mail, or electronically transmitted mail as soon as possible; a written report of the investigation shall be submitted to the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, within 7 days after the fatality” (CFR 606.170(b))
As it stands, we see the following potential solutions implemented at the various companies with which we work:
- Report via phone/fax within 7 days and follow-up with MedWatch within 15 day reporting period with 15-Day, initial checkbox checked
- Submit the MedWatch 3500A within 7 days with 15-Day checkbox unchecked but still indicating initial (essentially, submitting written report “early” as initial report)
- Submit the MedWatch 3500A within 7 days with 7-Day checkbox checked
- E2B submissions within 7-day with follow-up on or before day 15
Arguably, option 1 remains the closest to the MedWatch 3500A completion instructions. While correspondence and letters can be attached in most safety systems, this is typically performed in screens different from regulatory reporting requirements for the case (i.e. Letter or contact log records rather than submission history).
Option 2 is facilitated completely within the safety systems we implement/support and does appear in the submission tracking areas of the systems making compliance tracking arguably easier.
Option 3 would be the submission of the MedWatch 7-Day report in the system (using full Adobe to modify the 7-day check box prior to submission)even though .
Option 4: IND 7-Day Alert submission via E2B
To learn how we can help you with your drug safety and pharmacovigilance reporting needs, please let us know.
