Next: File the initial IND & receive an IND number
1. The IND Sponsor-Investigator compiles information in three broad areas:
- Nonclinical sections: Animal Pharmacology and Toxicology Studies: Preclinical data used to assess whether the product is reasonably safe for studies in humans. For studies of marketed drugs in new indications, this section might contain data from animal models supporting the utility of the drug in the new indication.
- Chemistry, Manufacturing & Controls (CMC) sections – detailed manufacturing information describing the composition, stability, and controls used for manufacturing the drug substance (DS; the active pharamaeutical ingredient) and the drug product (DP; the formulated clinical trial material).
- For marketed drugs to be utilized in your study in an unaltered fashion, the FDA should be able to rely on the information contained within the manufacturer’s submissions and drug label. Under certain circumstances, an Investigator-Sponsor may want to request a Right-of-reference from the manufacturer to refer to the information. Consult with VCTRS for more information if necessary.
- Clinical Protocol and Investigator Brochure: A detailed clinical study protocol, and Investigator Brochure are required sections of an IND application. The Investigator Brochure is primarily needed for multi-center studies and is a summary of information needed by participating investigators to assess the safety of the investigational product. For approved medications, a copy of the Prescribing Information may be used in place of an Investigator Brochure.
- Signed Form FDA 1571. This form is a formal contract with FDA to adhere to Informed Consent, IRB review, and general IND regulations (Form FDA 1572).
2. The IND Sponsor-Investigator writes the IND in the format of the TEMPLATE – IND Submission (under development).