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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 trial(s); 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 participants; and any risks of particular severity or seriousness anticipated on the basis of toxicological data in animals or prior trials 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.
Emtex Life Science medical writers 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.
FAQ: General Investigational Plan (GIP)
What is a General Investigational Plan (GIP)?
A GIP is a brief description of the strategy for investigating a drug in the upcoming year. It helps the regulatory authorities to anticipate the needs and direction of the future clinical program.
What information is included in a GIP?
A GIP describes the rationale for clinical development of the drug, the indications to be studied, the overall approach to study the drug in the next year, and any anticipated significant risks.
When is a GIP needed?
A GIP is required as part of an initial IND application and needs to be updated annually.
How can Emtex Life Science support the preparation of the GIP?
Emtex Life Science can author the GIP with team input, manage reviews, implement comments, facilitate discussions, and ensure consistency across multiple regulatory documents.
Why is professional medical writing support valuable for the GIP?
Professional medical writing support is valuable because it can facilitate collaboration between multiple functions and ensure consistency with other IND components, resulting in a coherent, high-quality document that meets regulatory expectations.