Morehouse School of Medicine

Data Safety and Monitoring Core

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.