UCSF DSM Examples & Checklist

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UCSF DSM Protocol Examples

These Data Safety Monitoring Protocols were generously provided by UCSF faculty to serve as models for new studies. They provide language to assist researchers in preparing protocols with Data Safety Monitoring Plans (DSMP) and Boards (DSMB), including large scale, multicenter trials, and more.

  • IMPACTT (pdf 130KB) DSMP for IMPACTT, a phase II, investigator-initiated, multi-center study including CT-guided biopsies for research tissue acquisition and use of investigational agents for pancreas cancer. Includes reporting guidelines and DSM oversight as provided by the UCSF-CCC Data Safety Monitoring Committee (DSMC).
  • POINT (pdf 160KB) DSMB guidelines for POINT, a phase III, large scale, multicenter trial with moderate risk (due to bleeding).
  • PRYSMS (pdf 24KB) DSMP for PRYSMS, an investigator-initiated trial with minimal risk (due to potential injury through yoga and stretching).
  • PRIDE (pdf 60KB) DSMB guidelines for the Program to Reduce Incontinence by Diet and Exercise (PRIDE). PRIDE is an investigator-initiated, NIH-funded study to determine if weight loss results in improvement in urinary incontinence among overweight and obese women with incontinence.
  • MF101 (access restricted to UCSF; pdf 44KB) DSMB guidelines for MF101, a phase III clinical trial. The aims are to determine the efficacy of 3 doses of MF101 to reduce the frequency and severity of hot flashes in postmenopausal women and to further evaluate the safety of MF101.

DSM Protocol Checklist

The DSM Protocol should 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)

The DSM Plan section of the protocol should describe:

  • Primary and secondary outcome measures
  • Inclusion/exclusion criteria
  • Sample size
  • List of participating enrolling clinics or data collection centers
  • Projected timetable
  • Target population distribution (e.g., women, minorities, etc.)
  • Data acquisition and transmission
  • Data entry methods
  • Data analysis plan
  • Quality assurance plan
  • Reporting mechanisms of AEs/SAEs to the IRB, FDA, and NIDA.
  • Reporting mechanisms of IRB actions to NIDA
  • Report of changes or amendments to the protocol
  • Trial stopping rules
  • Conflict of interest
  • Potential risks and benefits for participants
  • Collection and reporting of AEs and SAEs
  • Management of SAEs or other study risks
  • Plans for Interim Analysis of efficacy data
  • Responsibility for data and safety monitoring
  • Frequency of DSM reviews
  • Content of DSM report
  • DSM Board Plan (if applicable)

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