Investigator Brochure Template Fda
Blank investigator s brochure template free download and preview download free printable template samples in pdf word and excel formats.
Investigator brochure template fda. Under the auspices of the international conference on harmonization ich a document that provides general guidance on the. E6 good clinical practice. 6th edition dated september 7 2010.
Clinical protocol s refer to clinical components. Sample investigator s brochure template free download and preview download free printable template samples in pdf word and excel formats. For studies conducted under an investigational new drug ind application fda guidance notes that an investigator s drug brochure idb is usually required by the fda 21 cfr 312 23 a 5 and 312 55.
3 4 methylenedioxymethamphetamine mdma ind. Multidisciplinary association for psychedelic studies product. This 21 page investigator s brochure template is intended to assist you in the process of drafting an investigator s brochure for devices based on ich topic e 6 r1 guideline for good clinical practice.
Name of clinical. An investigator s brochure ib is perhaps one of the most important documents used in clinical trials after the clinical protocol. Consolidated guidance pdf 262kb.
Investigation until he she provides the sponsor with a completed signed statement of investigator form fda 1572 21 cfr 312 53 c. 7th edition release date. Investigator s brochure 21 cfr 312 23 a 5.
For suggested format of investigator s brochure refer to guidance for industry. Name and address of investigator. Investigator s brochure guideline 10 july 2002 4 general format and content of the investigator s brochure the major components and general organization of an ib are given in the ib template and explained further below.
