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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 optional required for Abbreviated trials. | 6127 | 6127 | |||||||||
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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 | ||||||||||
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Trial Oversight Authority Country* | Select the name of the country in which the oversight authority organization is located. | ||||||||||
Studies a U.S. FDA-regulated Drug Product |
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Studies a U.S. FDA-regulated Device Product |
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Unapproved/Uncleared Device |
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Post Prior to U.S. FDA Approval or Clearance |
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Pediatric Post-market Surveillance |
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Product Exported from the U.S. |
| Trial Oversight Authority Organization Name* | Select the name of the organization that oversees the trial from the drop-down list.|||||||||
FDA Regulated Intervention Indicator* |
Indicate whether the trial is regulated by the FDA by selecting Yes or No. 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.
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Delayed Posting Indicator* | 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. | ||||||||||
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Data Monitoring Committee Appointed Indicator Optionally, indicate whether a data monitoring committee has been appointed for this trial by selecting Yes or No. Info | |
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