Frederic C. Bartter
General Clinical Research Center (GCRC)
Overview of the
Requirement for a
Research
Subject Data Safety and Monitoring Plan (DSMP)
On June 10, 1998, the Office of Human Subjects Research (OHSR) of the National Institutes of Health (NIH) issued a mandate that each funding research Institute and Center (IC), such as the National Cancer Institute (NCI), should have a system for the appropriate oversight and monitoring of the conduct of clinical trials to ensure the safety of participants and the validity and integrity of the data for all NIH-supported or conducted clinical trials (http://grants.nih.gov/grants/guide/notice-files/not98-084.html ). On June 6, 2000, The Office for Protection form Research Risks (OPRR) became the Office for Human Research Protections (OHRP), a new office at the Department of Health and Human Services, charged with leading efforts for protecting human subjects in biomedical and behavioral research (http://www.hhs.gov/news/press/2000pres/20000606.html ).
Another mandate issued June 5, 2000 by NIH directed investigators to submit to the funding Institute and Center (IC), before the trial begins, a data and safety monitoring plan (DSMP) for Phase I and II clinical trials (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html ). Additionally, the Institutional Review Board (IRB) must approve the plan and determine what kind of data and safety monitoring process is required. The safety monitoring process may be by P.I. monitoring only, a single independent monitor, or a data and safety monitoring board (DSMB). On May 17, 2001, the National Center for Research Resources (NCRR) issued recommendations for General Clinical Research Centers (GCRCs) to assist the investigators in developing and implementing data and safety monitoring plans (DSMP) for each research study (http://www.ncrr.nih.gov/clinical/gcrcpatientsafety20010622.asp ).
For many Phase I and II trials, independent monitors of data and safety monitoring boards (DSMBs) may not be necessary or appropriate, particularly if the protocol involves no more than minimal risk. Continuous, close monitoring by the P.I., with prompt reporting of serious adverse events to the IRB (and others, as appropriate) may be adequate. At the time of initial review by the GCRC Advisory Committee (GAC), the appropriate level of monitoring required for the protocol under consideration is established.
At a minimum, all monitoring plans must include a description of the reporting mechanisms of adverse events (AEs) to the IRB, the FDA, study sponsor and the NIH. Investigators must ensure that all entities are informed of actions, if any, taken by the IRB as a result of its continuing review. In specific cases where the funding IC is the sponsor of the test agent, investigators must submit individual adverse event reports to the IC (as sponsor) in accordance with FDA regulations.
According to the November 18, 2002 memorandum from NCRR, any "protocol that places participants at significant risk" must describe the constitution and membership of an independent data and safety monitoring board. Please refer to the Level of Risk Review Form under "Level 4" for a description of the types of studies requiring a DSMB.
Quality Management (QM) and the Data and Safety Monitoring
Plan (DSMP)
Level of Risk Review Form (HTML)
(PDF)
Data and Safety Monitoring Plan Guidelines
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 03:05 PM
