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  • Research Subject Advocates (RSA) and Data Safety Core

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  • The National Institutes of Health (NIH) policy for data and safety monitoring states that: all clinical intervention studies require ongoing oversight and monitoring to ensure the safety of participants and the validity and integrity of data. The type of monitoring must be commensurate with the degree of risk, the size, and the complexity of the clinical trial. This includes Phase I (physiologic, toxicity and dose-finding), Phase II (efficacy) and Phase III (efficacy, effectiveness and comparative) studies.

    The purpose of the Data and Safety Monitoring Process at the Morehouse School of Medicine’s Clinical Research Center is: to ensure that research is conducted in compliance with the Safety Monitoring Plan approved by the Morehouse School of Medicine’s (MSM) Institutional Review Board (IRB), the Clinical Research Centers (CRC) and its Clinical Advisory Committee (CAC).

    The DSMP process prospectively assesses the assumptions made in the protocol design while the study is in progress, and makes recommendations for improving the scientific quality of the clinical trial, while protecting the integrity of human subjects. The CRC Data and Safety Monitoring Process consists of four components:

    1. Protocol Specific- Data and Safety Monitoring Plan
    2. Data and Safety Monitoring Committee
    3. Data and Safety Database and Tracking System
    4. RSA and PI Ongoing Review of Minimal Risk protocols

    The process is led by the Data and Safety Monitoring Committee (DSMC) whose primary role and responsibility includes: providing the MSM CRC with safety oversight related to compliance with best practice standards required by all IRB, NIH and FDA approved research protocols. It is anticipated that all Low and Moderate Risk (Level 1) interventional and non-interventional studies, nearly all Moderate Risk (Level 2) non-interventional studies and many Level 2 interventional studies conducted only at the MSM CRC generally will not require DSMCs. . A DSMC would be constituted in any large blinded trial considered high-risk to its target population or in a trial studying a vulnerable population. An interim analysis plan and the guidelines for stopping the protocol also will likely be required. Studies requiring DSMCs are almost invariably interventional or gene or cell therapy clinical trials.

    The DSMC serves several functions including:

    1. to review, evaluate and monitor adverse events occurring in all studies
    2. to review protocols identified by the RSA as having potential DSM concerns
    3. to serve as a pool of potential External Monitors
    4. to make recommendations to the CAC, IRB and CRC Director

    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:

    • 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

    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:

    • 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.

    Committee Composition: The MSM CRC Data and Safety Monitoring Committee Membership is composed of a multidisciplinary team of health professionals who are qualified to conduct frequent monitoring and ongoing safety review of MSM/IRB approved protocols. These committee members are experts in relevant clinical fields or specialties, are experienced in the conduct of clinical trials, are not currently involved with CRC studies and are without any conflict of interest financially, study-related, or interpersonally. Specialty areas of the members include:

    • Clinical Research (Minimum of 3 External Professionals-Physicians and PhD)
    • Biostatistics
    • Bioinformatics
    • Community Representative

    Ex Officio Members:

    • RSA
    • Clinical Nurse Manager
    • Regulatory Administrator
    • IRB representative

    Current CRC DSMC Members:

    • James Reed, M.D., Assoc. Chair of Medicine for Research
    • Michael Hieler, M.D., Chief Clinical Medicine
    • Camara Jones, Ph.D., Epidemiologist
    • Falah Sharmsa, Ph.D., Assoc. Prof. Biostat. Preventive Med.

    Ex-officio Members:

    • Fred Murphy, RSA
    • Marcus Hayes, Regulatory Admin.
    • Patricia Jackson, Clinical Trials Manager

    A written report by the DSMC is to be made upon completion of each meeting. This report is to contain findings/ minutes of the review and recommendations from the Committee. Recommendations include corrective actions required for major and minor concerns/deviations noted and the possible need for follow-up reviews. The RSA is to forward report results of DSMC reviews directly to the Investigator, the CRC CAC, and the IRB with recommendations for further action as necessary. DSMC reports prepared as part of the DSMP are to be forwarded to the IRB. In addition, all correspondence to and from the IRB regarding patient safety issues (i.e., SAEs, periodic reviews, etc.) should be forwarded to the CRCs RSA without delay.

    The MSM CRC Data and Safety Adverse Event Database and Tracking System permits the DSMC and Investigators to store, identify, compile and report the occurrence of adverse events, serious adverse events, as well as other potential human subjects safety risks, before and after they occur. This web-based tracking system, modeled after a system presentlyat another research institution, is part of the CRC Informatics development process. The system is developed using Cold Fusion Software and ACCESS Database provides aggregate analysis (e.g. information, tables, graphics, categorization of AE’s etc.) useful in tracking all adverse events reporting in collaboration with the MSM IRB. This system will be a key element in the data safety monitoring process conducted by the RSA and the CRC DSMC. The MSM CRC Tracking System/Database has several features including:

    • A listing of MSM IRB reported adverse events (anticipated and unanticipated) graded by anticipated severity (e.g. mild, moderate, severe);
    • MSM Web - interfaced;
    • User password protection and back- end relational database;
    • Identification of protocols that may require revisions, modifications, more investigator attention, or higher staff surveillance;
    • Alerts (Prevention) Principal Investigator and Research Team members of specific problems to anticipate;
    • Directs the attention of the MSM PI and Research Team members to the undesirable sequellae of study participation prior to (Prevention) any adverse events.

    The DSM Tracking System provides collaboration with the MSM IRB reports which show an adverse events profile graded by date and anticipated severity. Such reports are designed to be used by the DSMC at its meetings to assist in the evaluation of protocol risk.

    RSA and PI Ongoing Review of Minimal Risk protocols The RSA and PI will perform ongoing review, monitoring and analysis of individual and cumulative adverse events, and preparation of all summary reports.

    All adverse events, expected or unexpected, must be reported to the MSM IRB and the CRC RSA. Any serious adverse event (SAE) requires re-evaluation of the study’s risk level and determination of whether the study should be continued. Consent forms subsequently must be modified according to DSMC and IRB recommendations after the adverse event has been reported.

    Copies of adverse events reported to the MSM IRB also are submitted to the RSA administrative coordinator and kept on file in the RSA office. By signing the DSMP/DSMB Template, the principal investigator endorses the individual DSMP and, agrees to its implementation. Furthermore, the investigator agrees to inform the IRB and the RSA of any AEs, changes to the protocol and consent form, and DSMB reports.