Data Safety Monitoring Protocol Library

View and learn from exemplary Data Safety Monitoring plans and board guidelines which were generously provided by UCSF investigators. This resource provides language to assist researchers in preparing protocols with Data Safety Monitoring Plans (DSMP) and Boards (DSMB), including large scale, multicenter trials, and more.

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Frequently Asked Questions

  • What is a Data Safety Monitoring Plan (DSMP) and do I need one?

    A DSMP is a plan established to assure that each research study has a system for appropriate oversight and monitoring of the conduct of the study to ensure the safety of participants and the validity and integrity of the data. The DSMP should indicate specifically whether or not there will be a formal Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC).

  • What should a Data Safety Monitoring Plan (DSMP) contain?
    1. Study Risk Assessment
    2. Description of anticipated adverse events and their expected frequency
    3. Describe the steps you will take to minimize the risks/discomforts to subjects
    4. Description of safety monitoring
    5. Describe which research results, if any, will be made available to subjects and/or to their physicians
    6. Description of how AEs (adverse events) are graded
    7. Plan for AE reporting
    8. Describe who will perform the safety reviews: Individual versus Contracted Research Organization (CRO), or a Data and Safety Monitoring Board (DSMB)
  • More FAQs from the Work with Industry knowledge base