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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.
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Studies a U.S. FDA-regulated Drug Product*If (TBD), select Yes. Otherwise, select No. |
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Studies a U.S. FDA-regulated Device Product*If (TBD), select Yes. Otherwise, select No. |
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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. |
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Post Prior to U.S. FDA Approval or ClearanceIf (TBD), select Yes. Otherwise, select No. |
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Pediatric Post-market SurveillanceIf (TBD), select Yes. Otherwise, select No. |
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Product Exported from the U.S.If (TBD), select Yes. Otherwise, select No. |
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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. Note | |
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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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