Complete the following procedure for a Complete trial if it includes an Investigational New Drug (IND) or Investigational Device Exemption (IDE) as per US Food and Drug Administration regulations. If the trial was registered without IND/IDE information, you can provide it here. IND/IND information is optional for Abbreviated trials.
The choice of values for some fields in this section depend on values that you have selected in preceding fields. For example, if the Holder type is anything other than "NIH" or "NCI", NIH Institution / NCI Division/Program names are not available for selection.
How to Abstract IND/IDE Information
- Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
- Check out the trial. For instructions, refer to Checking In and Checking Out Trials.
On the Administrative Data menu, under Regulatory Information, click Trial IND/IDE. The Trial IND/IDE page appears. The IND/IDE Information section lists any IND/IDE records for the trial.
To add an IND/IDE record, click Add. The Add IND/IDE section displays IND/IDE data fields.
In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.
Field Label
Description/Instructions
IND/IDE Type*
Indicate the type of protocol.
Number*
Type the IND/IDE number.
Grantor*
Select the grantor from the drop-down list.
- If you selected IND, valid values are as follows:
- CDER – Center for Drug Evaluation and Research
- CBER – Center for Biologics Evaluation and Research
- If you selected IDE, valid values are as follows:
- CDRH – Center for Devices and Radiological Health
- CBER – Center for Biologics Evaluation and Research
Holder Type*
Select the holder type from the drop-down list.
- If you selected IND, valid values are as follows:
- Do one of the following:
- If you selected either NIH or NCI for the Holder Type, proceed to the next step.
- Otherwise, skip the next step.
In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.
Field Label
Description/Instructions
NIH Institution / NCI Division/Program*
Select an appropriate value:
If the holder type is NIH, select the associated NIH institution. For a list of valid values, see NIH Institution Code Values.
If the holder type is NCI, select the associated NCI Division Code. For a list of valid values, see NCI Division/Program Codes.
Availability of Expanded Access*
Indicate whether or not the drug or device is available outside any clinical trial protocol.
Expanded Access Record*
Specify the ClinicalTrials.gov identifier (NCT ID) for the associated Expanded Access record. - Click Save. The IND/IDE record you just created is added to the list of existing records.
- To make changes to a record, click the Edit icon in the Edit column next to the record you want to modify, and make changes in the Add IND/IDE page.
- To delete a record, click the Delete icon in the Delete column.
- To add another IND/IDE record, click Add, and complete the steps above.
- To save the details you have abstracted, click Save.
