Additional Resources

The Code of Federal Regulations (CFR) governing Investigative New Drug (IND) applications


Content and Format of an IND (21CFR312.23)


Information on submitting a new investigational drug application


Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs)


Clinical Investigator Information


Form 1571


Form 1572 (Statement of Investigator)


Form 3674 (Certification of trial registration on


Final Rule for Clinical Trials Registration and Results Information Submission


Investigator’s Checklist for IND Application Submission


NIH Recombinant DNA Advisory Committee


The NIH Review Process for Human Gene Transfer Trials


American Society of Gene and Cell Therapy


ICH Guideline for Good Clinical Practice E6(R2)