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.
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 NIH Institution / NCI Division/Program list, 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.
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.