Abstracting INDs and IDEs - Include 20170329

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

1. Search for the trial of interest. For instructions, refer to Searching for Trials in PA.

2. In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.

3. On the Trial Identification page, check out the trial. For instructions, refer to Checking In and Checking Out Trials. (This checkout step is optional for Super Abstractors.)

4. 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.

5. To add an IND/IDE record:

   1. Click Add. The Add IND/IDE section displays IND/IDE data fields.
      

   2. 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.

   3. 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.

   4. 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, refer to NIH Institution Code Values.

      • If the holder type is NCI, select the associated NCI Division/Program. For a list of valid values, refer to NCI Division and Program Values.

   5. 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
      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.

   6. Click Save. The system adds the IND/IDE record to the list of existing records.
6. To make changes to a record, click the Edit (pencil) icon in the Edit column next to the record you want to modify, and make changes in the Add IND/IDE section.
7. To delete one or more records:
   1. Select the record or records you want to delete (click the check box in the Delete column or click Select All).
   2. Click Delete.