Penn Medicine Clinical Research

Risk Assessment and Data Safety Monitoring Boards

Risk Assessment

Drugs

The risk information for a trial is typically contained and maintained in the Investigator Brochure.  If there is no Investigator Brochure, the information is generally contained in the protocol. 

Devices

The risk information for a trial is typically contained and maintained as part of the IDE application.

Abbreviated IDE (aIDE) for devices that are considered non-significant risk (NSR)

Full IDE for devices that are considered significant risk (SR)

The (Regulatory) Sponsor is responsible for risk assessment of a proposed study per Good Clinical Practice (GCP), including:

  • Risk identification
  • Risk evaluation
  • Risk control
  • Risk communication
  • Risk review, and
  • Risk reporting

ICH GCP E6 (R3) may be viewed here.

A risk assessment needs to be conducted during protocol development, and any time there is a significant change to the study.

  • Refer to Sponsor SOPs
    • Detail the roles and responsibilities for those who serve as regulatory sponsors within Penn Medicine.
  • Evaluate the risk of the study
    • Use the Sponsor Risk Assessment Tool to document the risk evaluation.
    • Consider whether a Data and Safety Monitoring Board (DSMB) is necessary. Refer to section below for additional details regarding DSMBs.
  • Establish a system for the detection, assessment, understanding and prevention of adverse effects or any other product-related problem.
  • Establish a robust data and safety monitoring plan (DSMP). Available templates include:

Please contact OCR Regulatory via email at psom-ind-ide@pobox.upenn.edu.

Data Safety Monitoring Board (DSMB)

As part of the overall risk assessment, the (Regulatory) Sponsor is responsible for determining if a Data & Safety Monitoring Board (DSMB) is needed, based on the risk of the study.

If it is determined that a DSMB will be used, the Sponsor is responsible for selection, qualification, and oversight of a DSMB,

A DSMB Charter will be created to clearly outline in detail how the DSMB will operate. 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. 

There are templates for the DSMB charter, qualification form, contact list, report, meeting minutes, and outcome letter. Please refer to OCR Forms, Tools, and Templates and select “DSMB".

Please email OCR Regulatory at psom-ind-ide@pobox.upenn.edu