Data Safety and the IRB
The Code of Federal Regulations addresses data safety monitoring in 45 CFR 46.111(a)(6) which states: "When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects."
What is a Data Safety Monitoring Plan?
A Data Safety Monitoring Plan (DSMP) describes how the Principal Investigator will to oversee the participants' safety and welfare. The level of detail in the plan should be based upon the degree of risk to the participants'. The intensity and frequency of monitoring should be adjusted to fit the expected risk level, complexity, and size of the particular study. Review of safety reports and data by a Data Safety Monitoring Board (DSMB) or medical monitor may be part of a DSMP.
What is a Data Safety Monitoring Board?
A Data and Safety Monitoring Board (DSMB)—also known as a Data Monitoring Committee (DMC) or a Data Safety Monitoring Committee (DSMC)—is an independent group that monitors the data and advises the study investigators and sponsors. The DSMB evaluates research data on an ongoing basis to assure participant safety and study integrity. The DSMB periodically reviews study data and unanticipated problems and makes recommendations based on their reviews as necessary.
In Guidance for Clinical Trial Sponsors, the FDA has defined a DMC as “a group of individuals with pertinent expertise that reviews on a regular basis accumulating data from one or more ongoing clinical trials. The DMC advises the sponsor regarding the continuing safety of trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial."
Resources
- Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees; Availability
- NIH Policies and IC Guidance for Data and Safety Monitoring of Clinical Trials
- NIH National Institute of Arthritis and Musculoskeletal and Skin Disease Policies, Guidelines and Sample Templates for Clinical Trials
- NIH National Institute of Allergy and Infections Diseases Decision Tree for Data and Safety Monitoring Plan
- FDA Guidance for Clinical Trial Sponsors - Establishment and Operation of Clinical Trial Data Monitoring Committees