Additional Resources
The Code of Federal Regulations (CFR) governing Investigative New Drug (IND) applications
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=312
Content and Format of an IND (21CFR312.23)
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.23
Information on submitting a new investigational drug application
Information for Sponsor-Investigators Submitting Investigational New Drug Applications (INDs)
Clinical Investigator Information
Form 1571
https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083533.pdf
Form 1572 (Statement of Investigator)
https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074728.pdf
Form 3674 (Certification of trial registration on ClinicalTrials.gov)
https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM048364.pdf
Final Rule for Clinical Trials Registration and Results Information Submission
https://prsinfo.clinicaltrials.gov/
Investigator’s Checklist for IND Application Submission
NIH Recombinant DNA Advisory Committee
https://osp.od.nih.gov/biotechnology/recombinant-dna-advisory-committee/
The NIH Review Process for Human Gene Transfer Trials
https://osp.od.nih.gov/biotechnology/faq-onthe-nih-review-process-for-human-gene-transfer-trials/
American Society of Gene and Cell Therapy
ICH Guideline for Good Clinical Practice E6(R2)