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. 

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