Recording INDs and IDEs

Enter the IND/IDE number and grantor fields only if your trial is/was conducted in the United States. You must indicate whether your trial qualifies as an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) protocol.

There are several dependencies between elements in the IND/IDE section. Follow the instructions below in the order in which they are presented. 

How to Register IND/IDE Trials

1. Select or enter the appropriate information in the text fields and drop-down lists. Fields are described in the following table.

   Instructions for recording IND/IDE Information

   Field Label	Description/Instructions
   IND/IDE Types*	If the trial involves an Investigational New Drug Application, select IND. If the trial involves an Investigational Device Exemption, select IDE.
   IND/IDE Number*	Enter the number assigned to an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) IND number formats You can enter the IND number in many formats. For example, for a biologics (BB) IND that contains the number 1234, you can type BB1234, 1234, or BB_1234. For IDE trials, type the IDE number associated with the grant.
   IND/IDE Grantor*	Select one of the following organizations that holds the IND/IDE approval: For IND trials: Center for Drug Evaluation and Research Center for Biologics Evaluation and Research For IDE trials: Center for Devices and Radiological Health Center for Biologics Evaluation and Research
   IND/IDE Holder Type*	Select one of the following holder types: Investigator Organization Industry NIH NCI
   NIH Institution, NCI Division/Program Code* (required if the holder type is NIH or NCI)	Select a code from the drop-down list. If you selected NIH from the IND/IDE Holder Type list, refer to NIH Institution Code Values for valid values. If you selected NCI from the IND/IDE Holder Type list, refer to NCI Division and Program Values for valid values.
   Availability of Expanded Access	If the drug, biologic, or device product is known to be available outside any clinical trial protocol, select Yes. If it is known to be unavailable outside any clinical trial protocol, select No. Otherwise, select Unknown. If you select Yes in this field, the Expanded Access Record field becomes available.
   Expanded Access Record	Specify the ClinicalTrials.gov identifier (NCT ID) for the associated Expanded Access record. Also, consider specifying each of these trials as an Associated Trial for the other. For instructions, refer to Associating Trials.

2. Click Add IND/IDE.
3. To delete an IND/IDE record from a trial, in the Action column, click Delete.
4. Optionally, to add another IND/IDE record, repeat the steps above.