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Your First Application to the GCRC
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Data and Safety Monitoring Plans
UW GCRC requirements for data and safety monitoring are based on overall NIH requirements,
and those of the National Center for Research Resources
(NCRR), which supports the GCRC.
NIH policy requires that investigators submit a general description of the Data and Safety
Monitoring Plan (DSMP) for clinical investigations
(biomedical and behavioral intervention studies) as part of the research application. A
general description of a monitoring plan establishes the overall framework for the study's
data and safety monitoring. It should describe the entity that will be responsible for
monitoring, and how adverse events
(AEs) will be reported to the Institutional Review
Board ( IRB ), the GCRC, and the appropriate federal
agencies (NIH, Office of Biotechnology Activities (OBA) and/or FDA) in accordance with
current NIH and/or FDA and local or state regulations. The purpose of a DSMP is to insure
the safety of participants, the validity of data, and the appropriate termination of studies
for which significant benefits or risks have been uncovered or when it appears that the
investigation cannot be concluded successfully.
The detailed DSMP must be reviewed and approved by the GCRC Scientific Advisory Committee
(SAC) prior to the initiation of the study, as part of the Application
to Use the GCRC. DSMPs may be submitted concurrently to the IRB and to the SAC (as
part of the GCRC application) for parallel review.
When designing an appropriate DSMP the following principles should be considered:
- All investigation requires monitoring.
- The benefits of the investigation should outweigh the risks.
- The monitoring plan should be commensurate with the risks.
- Monitoring should be commensurate with the size and complexity of the investigation.
DSMP Guidelines
Guidelines for developing a DSMP are detailed below. It is not necessary that the DSMP cover
all possible aspects of each element down to the last detail. Rather, the plan should describe
processes for dealing with these elements such that a reasonable reviewer would conclude that
the institution or investigator has a serious, robust process in place for assuring the safety
of research participants and the oversight of data integrity.
The minimum required DSMP content includes the following:
- Assessment of level of risk of the investigation
- The entity that will be responsible for monitoring
- Adverse event (AE) grading and attribution scale
- Plan for unanticipated AE reporting
- Plan for annual reporting of AEs
- Plan for safety review - by whom and at what frequency
The assessment of the level of risk of the investigation is an important component of the
DSMP, as it determines the intensity and structure of the subsequent monitoring procedures.
The NCRR requires a data safety and monitoring board (DSMB) for any
investigation that places participants at significant risk. The NIH requires a DSMB for Phase
III clinical investigations (or any multi-site clinical trial) involving interventions that
entail potential risk to participants. In general this would apply to all risk-level IV
studies, and may include some risk-level III studies. These requirements apply to all
investigations regardless of source of funding, (NIH, industry, local, etc.). The ultimate
decision regarding the level of risk of the investigation, and thus the monitoring
requirements, will be made by the IRB and the GCRC Scientific Advisory Committee (SAC). For
more information on NIH guidance on when DSMBs are needed, click
here.
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