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There are several dependencies between elements in the IND/IDE section. Follow the instructions below in the order in which they are presented.
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How to Register IND/IDE Trials
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)
Tip title 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, see refer to NIH Institution CodesCode Values for valid values.
- If you selected NCI from the IND/IDE Holder Type list, see refer to NCI Division /and Program CodesValues for valid values.
Anchor indcodes indcodes
Availability of Expanded AccessIf an experimental drug or device is available outside any clinical trial protocol, select Yes.
Include Page IND IDE Availability of Expanded Access field - Include 20170414 IND IDE Availability of Expanded Access field - Include 20170414 Expanded Access Record Include Page IND IDE Expanded Access Record field - Include 20170414 IND IDE Expanded Access Record field - Include 20170414 - For IND trials:
- Click Add IND/IDE.
- To delete an IND/IDE record from a trial, in the Action column, click Delete.
- Optionally, to add another IND/IDE record, repeat the steps above.