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Before you begin abstracting or validating any trial, be sure you check it out first. Otherwise you will not be able to modify any trial data.

 

How to Abstract Regulatory Information

  1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.
  2. Check out the trial. For instructions, refer to Checking In and Checking Out Trials.

  3. On the Administrative Data menu, under Regulatory Information, click Regulatory Information.
    The Regulatory Information page appears.

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Regulatory information includes human subject safety review and IND/IDE data. Some fields in this section are visible only when you have selected Yes or No indicators in preceding fields. Other fields may be visible but may not contain indicators. Regulatory information is required for Complete trials that will be submitted to ClinicalTrials.gov. Regulatory information is optional for Abbreviated trials.

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  • 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 for Complete trials only.

    Field Label

    Description/Instructions

    Studies a U.S. FDA-regulated Drug Product*If the trial studies one or more U.S. FDA-regulated drug or biologic products (a drug subject to section 505 of the Federal Food, Drug, and Cosmetic Act or a biological product subject to section 351 of the Public Health Service Act), select Yes. Otherwise, select No.
    Studies a U.S. FDA-regulated Device Product*If the trial studies one or more U.S. FDA-regulated device products (a device subject to section 510(k), 515, 520(m), or 522 of the Federal Food, Drug, and Cosmetic Act), select Yes. Otherwise, select No. If you select Yes in this field, the Unapproved/Uncleared Device field and Pediatric Post-market Surveillance field become available.

    Unapproved/Uncleared Device*

    Indicate whether the release of trial information on Cancer.gov is being delayed until after an interventional device has been approved or cleared by selecting Yes or No. Select No if the trial does not include a device. If you select Yes in this field, the Post Prior to U.S. FDA Approval or Clearance field becomes available.

    Post Prior to U.S. FDA Approval or ClearanceIf the responsible party authorizes posting of the study record on ClinicalTrials.gov prior to U.S. FDA approval/clearance of device product, select Yes. Otherwise, select No.
    Pediatric Post-market Surveillance

    If the U.S. FDA has ordered a pediatric post-market surveillance of the device product, select Yes. Otherwise, select No.

    Product Exported from the U.S.If the product is manufactured in the U.S. or one of its territories and exported for study in a clinical trial in another country, select Yes. Otherwise, select No.

    FDA Regulated Intervention Indicator*

    Indicate whether the trial is regulated by the FDA by selecting Yes or No.

    Note

    You must select Yes in the FDA Regulated Intervention Indicator field if the trial includes an IND or IDE.
    If the trial is interventional and you indicated that it is regulated by the FDA, the Regulatory Information section displays fields for Section 801. You are required to complete these fields.

    Section 801 Indicator*

    Indicate whether the FDA-regulated interventional trial is an applicable trial as defined in US Public Law 110-85, Title VIII, Section 801 by selecting Yes or No.

    Note

    If you indicated that the trial is applicable under Section 801, you are required to complete the Delayed Posting field.

    Data Monitoring Committee Appointed Indicator

    Optionally, indicate whether a data monitoring committee has been appointed for this trial by selecting Yes or No.

    Info

    This information is required for compliance with the Public Law 110-85 of the Food and Drug Administration Amendment Act of 2007. If you are unsure about how to classify a trial, or what information to provide, contact the FDA's regulatory affairs office.

  • To save the details you have abstracted, click Save.