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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 Yes or NO 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. | 6127 | 6127 |
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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
Search for the trial of interest. For instructions, refer to Searching for Trials in PA.
In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.
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.)
On the Administrative Data menu, under Regulatory Information, click Regulatory Information.
The Regulatory Information page appears.HTML Comment hidden true Screenshot TBD.
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. Include Page Regulatory Drug field - Include 20170414 Regulatory Drug field - Include 20170414 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. Include Page Regulatory Device field - Include 20170414 Regulatory Device field - Include 20170414 Unapproved/Uncleared Device
Include Page Regulatory Unapproved Uncleared field - Include 20170414 Regulatory Unapproved Uncleared field - Include 20170414 Post 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 PostUnapproved/Uncleared Device*
Prior to U.S. FDA Approval or Clearance field becomes available.Post Prior to U.S. FDA Approval or Clearance If 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. Include Page Regulatory Post Prior field - Include 20170414 Regulatory Post Prior field - Include 20170414 Pediatric Post-market SurveillanceIf the U.S. FDA has ordered a pediatric post-market surveillance of the device product, select Yes. Otherwise, select No. Include Page Regulatory Pediatric field - Include 20170414 Regulatory Pediatric field - Include 20170414 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. Include Page Regulatory Exported field - Include 20170414 Regulatory Exported field - Include 20170414 FDA Regulated Intervention Indicator*
Include Page Regulatory Intervention field - Include 20170414 Regulatory Intervention field - Include 20170414 Indicate whether the trial is regulated by the FDA by selecting Yes or No.
You must select YES in the FDA Regulated Intervention Indicator field if the trial includes an IND or IDE.Note
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.
If you indicated that the trial is applicable under Section 801, you are required to complete the Delayed Posting field.Note Include Page Regulatory Section 801 field - Include 20170414 Regulatory Section 801 field - Include 20170414 Data Monitoring Committee Appointed Indicator
Optionally, indicate whether a data monitoring committee has been appointed for this trial by selecting Yes or No.
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.Info Include Page Regulatory DMC Appointed field - Include 20170418 Regulatory DMC Appointed field - Include 20170418 - To save the details you have abstracted, click Save.