Data Safety and Monitoring Overview
For use with clinical trials and/or interventions
The central guardian of participants’ safety and welfare in clinical trials that are federally funded is the Office of Human Research Protections (OHRP), a department of the U.S. Department of Health and Human Services (DHHS); and the Office of Human Affairs, a department of the U.S, Food and Drug Administration (FDA). Enforcement the protection of human subjects is based on the Code of Federal Regulations, Title 45, Part 46 and Title 21, Part 50 respectively. It is therefore the policy that local Institutional Review Boards (IRBs) have provision for the appropriate oversight and monitoring of the conduct of interventional, clinical and prevention trials, as well as Investigational New Drugs (INDs) to ensure the safety of participants and the validity and integrity of the data.
As provided in federal guidelines, a DSM plan or system is required for all types of clinical trials (phase I, II, and III). Monitoring is essential for research involving investigational drugs, devices or biologics, as well as behavioral interventions that involve more than a minimal risk. FIU requires data and safety monitoring procedures that are specific to each study, and that are commensurate with the risk, size and complexity of the research project. The data and safety monitoring policy of FIU requires an investigator to have established a system to:
- Monitor the progress of the trial to assure the safety of participants or the ethics of the study;
- Assure data accuracy and protocol compliance; and
- Assure compliance with the prompt written requirements regarding the reporting of adverse events. The reporting of adverse events (AE) is in addition to, and does not take the place of, the requisite annual reports, periodic reports to the IRB at intervals appropriate to the degree of risk in the study, or reports providing the IRB with changes or amendments to an approved study.
Where external funding is being requested for a clinical trial, the principal investigator must adhere to the requirements of both the funding agency and university policy for data and safety management.
Please Note: Data and Safety Monitoring (DSM) plans and Data and Safety Monitoring Boards (DSMB) are normally only required for Intervention and Clinical Trial research projects. However, other types of research projects may also require a DSM plan if deemed necessary by the IRB (based on the sensitivity of research, type of population, and level of risk). In these special cases, the investigator will need to submit a DSM plan, but may not necessarily need to have an actual DSMB. The IRB will inform the investigator when a DSMB is not required in addition to the DSM in these special cases.
Data Safety & Monitoring Guidelines
DSM Guidelines Information on developing a Data and Safety Monitoring Plan (DSMP)
DSMB Guidelines Information on putting together a Data and Safety Monitoring Board (DSMB)
Agency Specific Guidelines
- NIH Policy For Data and Safety Monitoring (NIH DSMPolicy)
- Further Guidance on NIH DSM for Phase I & Phase II Trials (DSM for Phase I And Phase II Trials)
- The U.S. Food and Drug Administration (FDA) Policy for Good Clinical Procedures (GCP)
- Clinical Trials Resource Information (Resource Information) – go to Understanding Clinical Trials
- National Institute on Alcohol Abuse and Alcoholism; (NIAAA)
- National Eye Institute (NEI)
- National Institute of Allergy and Infectious Disease (NIAID)
- National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK)
- National Institute of Mental Health (NIMH)
Examples of RFP’s that require Data & Safety Monitoring
Examples of Studies utilizing Data & Safety Monitoring