1.15 — General Investigational Plan
General investigational plan including overall plan, clinical protocols, and investigator information per 21 CFR 312.23(a)(3)
Requirements by Phase
General investigational plan including overall plan, clinical protocols, and investigator information per 21 CFR 312.23(a)(3)
Requirements by Phase
IND Phase 1: required IND Phase 2: required IND Phase 3: required NDA: required
Content Requirements
- Overall investigational plan describing the rationale and general approach for evaluating the drug
- Indication(s) to be studied and general approach to be followed
- Types of clinical trials to be conducted (Phase 1/2/3)
- Estimated number of patients to be exposed
- Any risks of particular severity or seriousness anticipated
- Clinical protocol(s) with objectives, design, endpoints, and statistical methods
- Investigator information including qualifications and clinical site details
Expected Deliverables
- Investigational plan narrative
- Clinical protocol(s)
- Investigator information
ICH Guidelines: 21 CFR 312.23(a)(3)
Source: 21 CFR 312.23(a)(3)
References
Sections
Related Sections
Up toModule 1: Administrative Information and Prescribing InformationComplete table of contents for the submission
Cover letter identifying the IND submission type, serial number, and key information
Administrative information including contact details, certifications, and financial disclosures
Letters of authorization, right of reference statements, and cross-references to other applications
Application status requests including withdrawal, inactivation, and reactivation
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