Multidisciplinary Research BuildingData Safety and Monitoring Core (Page 3)
The DSMC serves several functions including:
- to review, evaluate and monitor adverse events occurring in all studies
- to review protocols identified by the RSA as having potential DSM concerns
- to serve as a pool of potential External Monitors
- to make recommendations to the CAC, IRB and CRC Director
- Purpose of DSMP
- Risk Category of Protocol (eg. minimal, moderate, high)
- Method of Monitoring and Reporting Adverse Events
- Name of Principal Investigator, Co-Investigators and other Research Team
- Brief Description of the study (eg. Study Goals and Hypothesis, Study Population etc.)
- Confirmation of NIH and MSM Ethics Course Completion
- Method of documenting and reporting Adverse Events
- modification of the studies data and safety plan;
- amendment to the studies Informed Consent document;
- assurance that confidentiality is maintained in the study as mandated under HIPAA;
- written recommendation to the PI and IRB for study suspension.
The submission of protocols to the MSM/CRC includes a requirement for a mandatory Data and Safety Monitoring Plan (DSMP). CRC Principal Investigators must submit a DSMP as part of the initial CRC research application packet. The DSMP is the responsibility of the Principal Investigator (PI) and is subject to review and approval by the CRC/ CAC and the MSM/ IRB. The CRC RSA will provide technical assistance to the PI in the development of the plan. These plans are stored as part of file located within the office of the CRC RSA. Each DSMP submitted must include the following:
Investigators will be required to utilize one of three methods for data and safety monitoring. The method used will vary based on level of risk. Investigators for each study must complete a DSMP Template. The template includes six principal sections, determination of risk to study participants and formulation of the data safety and monitoring plan. The assessment of risk section of the Template takes into account the size and type of study, proposed study procedures, interventions, and special circumstances unique to the study and the study population.
The DSMC meets monthly, or on an as needed basis (on call), to discuss and review reported AEs and, to determine if follow-up action is required. In addition, the DSMC monitors all greater than minimal risk studies and all studies which the MSM IRB, CRC CAC or CRC Director recommends for ongoing review. Examples of the types of follow- up actions by the committee include:
720 Westview Drive SW, Atlanta, Georgia 30310 - 404 756 5787