Data & Safety Monitoring for Clinical Trials

Data & Safety Monitoring Plans

Data & Safety Monitoring Plans

The NIH requires data and safety monitoring for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III); etc.

Monitoring should be commensurate with risks -- The method and degree of monitoring needed is related to the degree of risk involved.  A monitoring committee is usually required to determine safe and effective conduct and to recommend conclusion of the trial when significant benefits or risks have developed or the trial is unlikely to be concluded successfully.

Data Safety Monitoring Plans
A Data and Safety Monitoring Plan (DSMP) is just one of the mechanisms used to ensure the safety of study subjects as well as maintain data validity, integrity, and scientific merit. UCSF policy requires that all interventional studies involving more than minimal risk must include a DSMP. DSMPs depend upon many variables, such as the degree of risk, disease being studied, subject population, and number of sites where the research is being conducted. Complex DSMPs frequently include a Data Safety Monitoring Board (DSMB).

UCSF Data Safety Monitoring Plan Information and Templates
To assist investigators in complying with the NIH data safety monitoring policy, the campus has developed guidance and sample DSMP templates for campus use.

CTSI Data Safety Monitoring Protocol Library
The CTSI Data Safety Monitoring Protocol Library provides language to assist researchers in preparing protocols with Data Safety Monitoring Plans (DSMP) and Boards (DSMB), including large scale, multicenter trials, and more.  Access is limited to UCSF researchers.

Need assistance or have clinical study management questions?
Please contact CTSI Design Services

Last updated 6 Jun 2012

The Data Safety Monitoring Board (DSMB)

The Data Safety Monitoring Board (DSMB)

DSMBs are made up of multidisciplinary members who are knowledgeable in the conduct of research, and should include those with backgrounds in biostatistics, experimental design, bioethics, and experts in the medical field of concern.

DSMBs are responsible for reviewing data and endpoints on a timeline set forth by the DSMP in the protocol, and are typically required for the following types of studies:

  • More than minimal risk 
  • Multiple study sites. It is more difficult to recognize a pattern of increased or unusual problems when investigators treat small fractions of the population separately
  • Vulnerable population (pediatric, geriatric)
  • Blinded studies 
  • New therapies or science 
  • Highly toxic therapies or dangerous procedures.
  • High expected rates of morbidity or mortality in the study population.
  • High chance of early termination of the study.

Need assistance or have clinical study management questions?
Please contact CTSI Design Services.

Last updated 19 Dec 2011

 
DSMPs and DSMBs at UCSF

DSMPs and DSMBs at UCSF

DSMB Collaboration with the IRB
NCI guidelines are widely considered to be the most comprehensive and set forth requirements for DSMB composition and function; note that it is required that a majority of the members be drawn from outside the institution (or institute) conducting the study. DSMB membership is usually comprised of:

  • Experts in the fields of medicine and science that are applicable to the study,
  • Statistical experts,
  • Lay representatives, and
  • Other who can offer an unbiased assessment of the study progress

The DSMB is not specifically required to communicate with the IRB, but the intent is clear that the important information get to the IRB: "The study leadership will provide information on cumulative toxicities and relevant recommendations to the local principal investigators, to be shared with their IRBs."

DSMP Checklist

  • 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

 

Last updated 21 Dec 2011

Related Guidance, Tools & Templates

Related Guidance, Tools & Templates

National Institute of Diabetes and Digestive and Kidney Diseases (NDDK):  

DSMP Guidelines from Various NIH Institutes:

National Cancer Institute

Need assistance or have clinical study management questions?
Please contact CTSI Design Services.

Last updated 19 Dec 2011