Frederic C. Bartter
General Clinical Research Center (GCRC)
Data Safety and Monitoring Plan (DSMP) Guidelines
All GCRC protocols, not just clinical trials, are to have a data and safety monitoring plan (DSMP) (http://www.ncrr.nih.gov/clinical/gcrcpatientsafety20010622.asp ).The Data and Safety Monitoring Plan (DSMP) must address each of the specific indicators and a schedule for periodic monitoring. The DSMP plays an essential role in protecting the safety of the participants and the integrity of the research. GCRC applicants must submit a description of the DSMP for all clinical studies. The DSMP must be submitted to the Institutional Review Board (IRB) and the GCRC Advisory Committee (GAC). Both the IRB and the GAC must approve the DSMP prior to the accrual of human subjects. Additionally, specialized protocols such as gene transfer, must be submitted to other entities for safety review and regulatory permission.
When designing the appropriate DSMP, the following principles should be considered:
all investigations require monitoring;
the benefits should outweigh the risks;
the monitoring plan should be commensurate with the risks; and,
the monitoring should be commensurate with the size and complexity of the investigation.
Remember that the NIH requires a Data Safety Monitoring Board (DSMB) for all phase III clinical trials. For phase I and II trials, a DSMB may be appropriate if the studies have 1) multiple clinical sites; 2) are blinded; or 3) employ particularly high risk interventions or vulnerable populations (http://ohsr.od.nih.gov/info/rinfo_18.php3 ).
The minimum required DSMP content includes the following information:
the entity that will be responsible for monitoring`
monitoring parameters
informed consent processes and consistency with protocol descriptions
data gathering processes
adverse event (AE) monitoring: a) grading and attribution scale; b) plan for unanticipated AE reporting; and, c) plan for annual reporting of AEs
plan for safety review - by whom and at what frequency
To assist the researcher in determining whether a DSMB is appropriate for certain clinical trial phase studies, please refer to the "Level of Risk Review Form."
The DSMB must include 1) clinical trial experts, 2) biostatisticians, 3) bioethicists, and 4) clinicians knowledgeable about the disease and treatment under study.
For independent investigations, the composition of the committee may include internal personnel (i.e. personnel affiliated with UTHSCSA.
For NIH-supported research (or research supported by another Federal agency), the composition of the committee must comply with the sponsors requirements.
For cooperative group research, the composition of the committee may need to include external personnel (i.e. personnel not affiliated with UTHSCSA) if UTHSCSA is the coordinating center for the multi-site trial.
For industry-based research, the sponsor is responsible for overall data and safety monitoring.
Overview of the
requirements for a Data and Safety Monitoring Plan (DSMP)
Level of Risk Review Form (HTML)
(PDF)
Quality Management (QM) and the Data and Safety Monitoring
Plan (DSMP)
Data and Safety Monitoring Plan document
PDF Word
VA Policies related to the GCRC DSMP
Joint Commission 2004 Hospital Accreditation
Standards Applicable to the GCRC DSMP
RSA responsibility with
Quality Management (QM) and Data and Safety Monitoring (DSM)
Date page last modified: 08/08/05 03:04 PM
