However, there are circumstances when a more extensive plan that includes a Board or Committee may be needed (see Guidance on Data and Safety Monitoring Committees). Generally the plan can be carried out by the PI and research team.Who (the individual or entity) is responsible for the oversight of the data and safety monitoring plan?.There are four main issues that must addressed in each plan and the following information will assist you in developing your plan. The IRB will make the final determination regarding the level of monitoring required. A plan for a minimal risk, non-interventional study will not require the complexities needed for a Phase II drug trial. Write a data and safety monitoring plan that is appropriate for the study design. multicenter) Īs with all procedures outlined in an IRB application, you must adhere to what the IRB approves. the number of sites involved (single vs.The following factors should also be considered when determining the level of monitoring: Various funding sources also may have additional requirements related to data and safety monitoring which must be considered when preparing your application. a descriptive psychosocial interview study), and the degree of risk to subjects. The method and extent of monitoring may vary across different types of studies, depending on multiple factors, including the experimental design and complexity of the study (e.g., Phase I vs. Where appropriate, the research plan makes adequate provisions to protect the privacy of subjects and to maintain the confidentiality of the research data (45 CFR 46.111(a)(7) and 21 CFR 56.111(a)(7).Where appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.(45 CFR 46.111(a)(6) and 21 CFR 56.111(a)(6).The federal regulations governing research with human subjects require the following: It is required that every research study include a formal data and safety monitoring plan, except those studies designated as “exempt”. A data and safety monitoring plan (DSMP) is a specific plan, developed by the local principal investigator (PI) that outlines how study progress will be monitored throughout the course of the research to ensure the safety of subjects as well as the integrity and confidentiality of data.
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