Social and Behavioral Sciences Institutional Review Board

Submitting an AE/SAE via e-mail

AE- Adverse Event / SAE- Serious Adverse Event Process for submitting an AE/SAE to the SBSIRB via e-mail.  While the final paper documentation required for this is no less than that required for paper submittals, submittal via e-mail will help to speed up the review process by eliminating time loss for materials in transit and allow for further information to be more easily made a part of the official record prior to issuing the final acknowledgement.

1. Download/Save the SBSIRB Forms File . Rename the file using the last name of the Primary Investigator for the first part of the file name. This file contains a tab for Adverse Event Reports.
2. Send the report as an attachment to the SBSIRB (SBSIRB@research.buffalo.edu) along with any other pertinent information including the seperate memo requested on the form describing the event and outcome.
3. The Administrator will then forward this to the board chair and other board members for review and comment.
4. The SBSIRB Administrator will contact the investigator for any further information needed or request amendments of the protocol if necessary.
5. After all pertinent information is assembled and the chair is ready to provide acknowledgement of the AE/SAE, the Administrator will request that the investigator deliver two signed copies of the AE/SAE report to the SBSIRB Administrator and the administrator will provide a signed acknowledgement of the AE/SAE to the Investigator.