Social and Behavioral Sciences Institutional Review Board

Submitting a Serious Event or Problem (SEP) Report via e-mail

Note that SEPs include items that were previously referred to as Adverse Events as well as other reportable problems that could occur in the conduct of a protocol.

Table of Contents

• Classifying Potentially Reportable Events and Problems
• Submitting Initial On-Site SEP Reports
• Follow-Up Reports
• Timeframes for Reporting On-Site SEPs and Follow-Up Reports
• Reporting an Off-Site SEP
• Reporting Non-Serious Events/Problems

Classifying Potentially Reportable Events and Problems

By working through the appropriate items in the chart below, an investigator should be able to determine how a potentially reportable event should be classified, if it must be reported and, if so, how to report the event to the IRB.

Process for submitting an initial On-Site SEP report to the SBSIRB via e-mail.

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 tabs for all for the required SBSIRB forms. Be sure to fill in all pages needed for the type of submittal you are making as specified on the Directions Page. Extraneous forms should be left in the workbook and NOT deleted in case they are discovered to be necessary at a later point in time.


2. The Serious Event or Problem worksheet is interactive. Responses in the form will trigger other boxes to become shaded blue, indicating that they need to be filled in. Answering all of the questions in Section 1 will give an indication of if, when and how to report events.


3. When submitting substantive materials electronically to the SBSIRB, the number of attachments should be minimized by combining all files of the same file extension type (ex. .doc, .pdf) into a single file with the last name of the Primary Investigator for the first part of the file name. Submittals with an inordinate number of attachments that could have been combined into a single attachment will be returned to the investigator at the discretion of the SBSIRB staff before sending for review. In all cases when materials cannot be sent electronically or if you would like to send materials in a file format other than .doc, docx or .pdf, the SBSIRB staff should be contacted prior to submitting materials in order to discuss how to proceed.


4. Send an e-mail to the SBSIRB (SBSIRB@research.buffalo.edu) requesting acceptance of the SEP report. Provide as one attachment the excel form file containing the forms that you completed in step 1 above. Provide as a second attachment any substantive materials necessary. Please limit your application to these two (2) attachments.


5. If all application materials are complete, the SBSIRB Administrator will notify the investigator via e-mail that the materials have been sent to the reviewers. Once reviews are received, the Principal Investigator (PI) will be notified of any changes requested or further materials needed.


6. After an SEP report has been reviewed by the board, the PI and faculty sponsor will be notified via e-mail of the action. The e-mail will acknowledge the closure and no attachments will be provided. For Renewals, t Depending on the nature of the amendment(s), The e-mail will contain an attachment consisting of an acknowledgment memo, HS1A summary pages and any additional materials approved as a part of the SEP review as a single password protected pdf document with a University at Buffalo Crest watermark indicating approval by the IRB. All pages of this document will also contain a footer that includes the approval and expiration dates of the current documentation. When documentation is provided in this manner the project is approved and no signatures of the investigator, faculty sponsor or IRB representative are required to further document approval by the University at Buffalo IRB.

   The approved pdf file should be printed and placed in the investigator’s indicated repository. This document must be used with the watermark and footer to produce copies of consent documents to be signed by participants when signed documentation of consent is a part of the approved protocol. It is recommended but not required that any advertisements, consent information sheets or other printed materials approved as a part of this protocol also be used with the watermark and footer present.

   This document will not be signed unless an investigator needs a signed document in order to meet the requirements of research sponsors or other persons outside of the University at Buffalo. In these cases the investigator must send or bring one hard copy of this full document to the IRB administrator who will provide an appropriate signature and date.

   The document will be password protected, but the file may be copied. If for any reason the researcher needs to produce an electronic file with less than the full document, pages in a copy of this file may be deleted using the Acrobat writer.

Follow-Up Reports

Use this form to notify the IRB of changes to previously reported Serious Events/Problems (SEPs) including:

1. When the reported relationship is changed (e.g., related to unrelated or unknown to related)
2. When there is a change in outcome (a subject suffering a stroke subsequently dies)
3. When a reported risk of breach of confidentiality changes to an actual breach

E-mail the form to SBSIRB@research.buffalo.edu. Follow-up reports should be sent to the SBSIRB within the same timeframes as used for initial reports.

Timeframes for Reporting On-Site Serious Events/Problems (SEPs) to the IRB

Reporting an Off-Site SEP

When an investigator determines that a Safety Report or other notification from a collaborating site constitutes an SEP that is unanticipated and related or possibly related to participation in the research or is otherwise associated with the research, the investigator is responsible for submitting to the IRB the following information along with a copy of the off-site report (e.g., a Med-Watch, IND safety report, or other form of notification) within 5 working days of investigator knowledge or notification:

• Title of the research project
• Investigator’s name
• IRB project number
• Indication of when the event occurred
• Description of the event
• Pertinent subject history, when appropriate
• Basis for determination that the event/problem is a SEP that is unanticipated and related or possibly related to participation in the research or is otherwise associated with the research

Reporting an On-Site Non-Serious Events/Problems

The following types of “non-serious” events/problems must be reported to the IRB using the Amendment Form, as they occur, according to the instructions in the chart below:

• “Non-serious” events that effected the study (i.e., events/problems that require changes to the study in order to prevent further occurrences)
• “Non-serious” events/problems that impacted on the rights and welfare of the subjects

Non-serious events that did not effect the study or impact on the rights and welfare of the subjects are not required to be reported to the IRB.

Investigators are responsible for reporting “non-serious” events and problems according to the nature of the event/problem and according to the manner and timeframes indicated on the Chart below: