Overview

The NIH defines a “clinical trial” as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”

Data and Safety Monitoring Plan (DSMP)

If your study involves a clinical trial you must include a Data and Safety Monitoring Plan (DSMP) commensurate with the level of risk for your study. The DSMP consists of a written description of the procedures for reviewing accumulated data in an ongoing research protocol to ensure the safety of research participants and the continuing validity and scientific merit of the protocol. This DSMP must be reviewed and approved by the IRB before any human subjects are recruited. Any changes to the DSMP must also be approved by the IRB prior to implementation.

Required Elements of the DSMP

The DSMP should include a general description of a plan establishing the overall framework for the oversight and monitoring of a study. When formulating the DSMP, the PI, and the study team should consider the protocol, phase, intervention(s), target population, subject safety and privacy, risks and benefits involved in the study, data integrity and confidentiality, study coordination, and how the team will address each of these elements. When modifications to the DSMP are made before the trial begins (e.g., in response to the peer review or IRB review), a final IRB-approved monitoring plan must be submitted to the funding agency program official prior to the commencement of human subjects’ activities. The minimum required DSMP content should include the following elements:

  1. Summary of the Protocol
    1. A brief description of the study design (e.g., interventions, procedures, tests and scans, biospecimen collection, interviews and focus groups, study visits)
    2. Primary and secondary outcome measures/endpoints
    3. Sample size and target population
    4. Inclusion/exclusion criteria and how the criteria will be evaluated
    5. For multi-site trials, a list of proposed participating clinical sites and a description of each site’s role
  2. Roles and Responsibilities
    1. Identification and description of individuals responsible for monitoring the trial (e.g., PI, ISM, DSMB), their roles, qualifications, and the frequency of the monitoring activities.
  3. Trial Safety
    1. Description of the potential risks and the measures in place to protect participants against foreseeable risks
    2. Description of any specific events that would preclude a participant from continuing the intervention
    3. Description of the consent/assent procedures (e.g., by whom, how and under what conditions will a subject be consented)
    4. Description of the mechanisms in place to protect subject privacy (e.g., interviews will take place in a private room, whether results of testing data will be shared with participant’s legally authorized representative, privacy for minors, secure means of communication between investigators and participant, e.g., telephone, web portal)
    5. Description of the trial stopping rules for the study, if any (e.g., increased rates of negative outcomes among participants)
    6. Description of the plan for management of incidental findings (e.g., unexpected results potentially linked to increased risk for participants)
    7. Description of the process for the disclosure of any conflicts of interest that may potentially challenge participant safety or bias the data and how the conflict will be managed
    8. For multi-center studies, a description of the procedures for ensuring compliance with the monitoring plan including requirements for data reporting across study sites
    9. Description of the data security in place to protect the confidentiality of the data (e.g., password protected encrypted electronic records) and any limits to confidentiality (e.g., mandatory reporting requirements)
  4. Reportable Events
    1. Description of the process and timelines (e.g., hours, days) for collecting and reporting Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Problems Involving Risks to Subjects or Others to appropriate monitoring and regulatory entities.
  5. Data Management and Analysis
    1. Identification of data sources (e.g., questionnaires, medical records, biospecimen collections, audio/video recordings)
    2. Description of the security measures in place to protect data sources including how the data will be labeled and stored
    3. Description of quality assurance procedures in place to ensure the validity and integrity of the data

Data and Safety Monitoring Board (DSMB)

If your study involves an NIH-defined Phase III or NIH-sponsored multisite clinical trial, your DSMP must include the use of a Data and Safety Monitoring Board (DSMB). The DSMB is an independent group of experts responsible for reviewing study data for data integrity; participant safety; study conduct and progress; and providing directives regarding study continuations, modifications, and terminations.

DSMB members are expected to be independent from any professional or financial COI with the research project and investigators. Independence ensures that competing interests do not unduly influence the DSMB and supports objectivity that enhances the safety of participants and the integrity of the trial data.

Additional Information