Investigator-held INDs

Initial IND Submission to FDA
Initial IND Submission Checklist
Initial IND Submission Transmittal Letter
Initial IND Application Template

IND Amendment
IND Amendment Checklist
IND Amendment Transmittal Letter

IND Safety Reporting for FDA
IND Safety Reporting Transmittal Letter
IND SAE (Dear Doctor) Transmittal Letter

IND Annual Report for FDA
IND Annual Report Checklist
IND Annual Report Transmittal Letter
IND Annual Progress Report Template

IND Withdrawal
IND Withdrawal Transmittal Letter


Investigator-Written Trials
Biomedical Protocol Template
Drug Diary Template-Multiple Drugs
Drug Diary Template-Single Drug