Investigational plan

A description of the overall plan for the study.

The investigational plan for drug or biologic should include the following: FDA: 21 CFR 312.23(a)(3)(iv)

• The rationale for the drug or the research study;
• the indication(s) to be studied;
• the general approach to be followed in evaluating the drug;
• the kind of clinical trial(s) to be conducted in the first year following the submission (if plans are not developed for the entire year, the sponsor should so indicate);
• the estimated number of patients to be given the drug in those studies; and
• any risks of particular severity or seriousness anticipated on the basis of the toxicological data in animals or prior studies in humans with the drug or related drugs.

The investigational plan for an investigational device should include the following: FDA: 21 CFR 812.25, Investigational Plan

• purpose;
• protocol;
• risk analysis;
• description of the device;
• monitoring procedures;
• labeling;
• consent materials;
• Institutional Review Board (IRB) information;
• information about other institutions where a part of the investigation may be conducted; and
• additional records and reports maintained on the investigation.