A General investigational Plan (GIP) is a brief description of the overall plan for investigating the drug for the following year. It is a component of an IND application submitted to the US FDA to get approval for starting clinical trials and shipping unapproved drugs across state lines. Its purpose is to place the clinical development plan for the investigational new drug into perspective and helps FDA anticipate the needs of the future program.
The GIP contains the rationale for the drug or the specific study(ies); the indication(s) to be studied; the general approach for evaluating the drug; the kinds of clinical trials to be conducted in the first year following the submission (if plans are not developed for the entire year, this should be indicated) with the estimated number of patients; and any risks of particular severity or seriousness anticipated on the basis of toxicological data in animals or prior studies in humans with the drug or related drugs.
The development of this document requires input from multiple functions. For initial IND applications, the parallel development of several other IND components might be a challenging factor.
The GIP will be updated annually as part of the IND Annual Report. A description of the GIP for the coming year will replace the one submitted 1 year earlier.
The Medical Writer can manage and coordinate the document development process (eg, write sections, circulate for review, implement comments), often in combination with the Previous Human Experience and the Investigator’s Brochure for an initial IND application, and can help to generate a clear, well-structured, and coherent document.