Risk Assessment and Data Safety Monitoring Boards

Risk Assessment 

The Sponsor is responsible for risk assessment of a proposed study, including risk identification, evaluation, control, communication, review, and reporting (ICH E6 R2). 

There is a tool available to assist Sponsors in this task (Sponsor Risk Assessment). This tool should be utilized prior to study start up and revisited, as needed, over the course of the trial.  Sponsors can also refer to the OCR Pharmacovigilance Work Instructions to establish a system for adverse effect risk collection, assessment, and reporting.   

The risk information for a trial is typically contained and maintained in the Investigator Brochure (Drugs) or the Investigational Plan (Devices). If there is no Investigator Brochure, the information is generally contained in the protocol. 

Please reference PSOM SOP 004 for additional risk and safety monitoring requirements of the Sponsor.

Data Safety Management Board (DSMB)

This Sponsor is responsible for determining if a Data & Safety Monitoring Board (DSMB) is needed, as well as the selection, qualification, and oversight of a DSMB. The decision to have a DSMB is based on risk and made by each sponsor team for a specific study. For guidance on the establishment and operation of DSMB, refer to FDA Guidance for Industry: Establishment and Operation of Clinical Trial Data Monitoring Committees.  

The CTSA Collaborative Data and Safety Monitoring Board (DSMB) Workgroup has created an online DSMB Training Manual, which focuses on investigator-initiated studies. The manual may be helpful in learning more about DSMBs in general, as well as learning to work working effectively with DSMBs.

If a DSMB will be used, it is essential that details are clear regarding how the DSMB will operate, typically outlined in a DSMB Charter. All communications with the DSMB must include a statement that the information being shared is confidential and the information must be shared in a secure manner.   

The DSMB should review and provide feedback on a study prior to activation, and it is strongly recommended that a study-specific DSMB report template is generated prior to study initiation.  For additional DSMB-related templates, please go to the OCR Forms, Tools, and Templates, and select “DSMB.” For additional resources or information on DSMBs please contact OCR Regulatory at PSOM-IND-IDE@pobox.upenn.edu