Guidance On Completing Fda Form 1571 (Page 3 of 4) in pdf

Guidance On Completing Fda Form 1571 Page 3

Guidance on completing FDA Form 1571 (cont’d)

(Taken from “Fecal Microbiota Transplantation: A Practical Update for the Infectious Disease Specialist” –

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Part 6 (Protocols). Section a, Study protocol: This section will require the submission of the study protocol itself. The protocol must provide

detailed information about patient (recipient) and donor evaluation and testing procedures. Guidance has been published previously and can be

used as a template.

The protocol should include detailed information regarding the collection and handling of fecal material, methods of

preparation of the fecal sample, as well as indicate the dose, route, and duration of administration. Details regarding endpoints (e.g., resolution

of diarrhea, conversion to negative C. difficile testing by toxin assay and/or PCR) and long term follow up of treated patients must also be

included. If the sponsor has created a case report form (CRF) to collect data, the form should be included with the IND application.

The protocol must include a description of risks associated with FMT, including those not yet reported (e.g., intestinal perforation, sepsis,

transmission of an infectious agent from the donor stool). If the protocol will include endoscopy, the risks associated with these procedures

should be discussed separately. An informed consent form that includes specific language explaining that FMT is an investigational procedure

Bakken JS, Borody T, Brandt LJ, et al. Treating Clostridium difficile infection with fecal microbiota transplantation. Clin Gastroenterol Hepatol 2011 Dec;

9(12):1044-9

Guidance On Completing Fda Form 1571 Page 3

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