Investigator’s Brochure (For any drug/product under investigation) For studies that involve administration of investigational drugs/products, this section should include: Brochure(s) (IB), or equivalent Investigator’s Or Package Insert. Include labeling for approved medications. The purpose of this document is to provide information on the mechanism of action, possible risks and adverse reactions, and the adverse reactions associated “expected” with the previous use of the drug/product. If the package insert or the Brochure is Investigator’s amended during the trial or is updated, it should be included here. Required for clinical studies regulated by FDA under IND FDA Form 1572 and 1571 FDA Form 1572 for IND studies when: A study involves an investigational drug
Investigator’s Brochure (For any drug/product under investigation) For studies that involve administration of investigational drugs/products, this section should include: Investigator’s Brochure(s) (IB), or equivalent Or Package Insert. Include labeling for approved medications. The purpose of this document is to provide information on the mechanism of action, possible risks and adverse reactions, and the “expected” adverse reactions associated with the previous use of the drug/product. If the package insert or the Investigator’s Brochure is amended during the trial or is updated, it should be included here. Required for clinical studies regulated by FDA under IND FDA Form 1572 and 1571 FDA Form 1572 for IND studies when: A study involves an investigational drug
extramural-essential-documents-binder-file-tabs.docx