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

Guidance On Completing Fda Form 1571 Page 4

that may be associated with potential defined risks should also be included with the IND application. The protocol must have a section detailing

the potential Adverse Events (AE) the clinician/investigator plans to capture. Most protocols should outline specific AEs at baseline and solicit

potential AEs at follow up visits; however, unsolicited AEs (symptoms that patients volunteer) may need to be recorded as well. All documented

AEs should be reported to the FDA in a timely fashion—within 7 calendar days for serious AEs (e.g., death, illness requiring hospitalization).

Detailed guidance for safety reporting requirement can be found here:

Part 7 (Chemistry, manufacturing, and control data): This requires a brief description of donor material. An example of appropriate language

would include statements about the heterogeneity of human stool from person to person; however, human stool consists mostly of bacteria and

water.

Part 8 (Pharmacology and Toxicology data): This section should include a statement of the potential risks associated with FMT. However, it

should be emphasized that the overall risk is low and there have been no significant reported complications to date.

Guidance On Completing Fda Form 1571 Page 4