If the record is for an applicable clinical trial of an approved product, then you will need to enter the data into our system.
In general, reporting of “basic results” in ClinicalTrials.gov is required for those trials that were required to be registered under PL 110-85 and include drugs or devices approved or cleared by the FDA. The Responsible Party must submit basic results data not later than 1 year after the “primary completion date” (named “completion date” in the law), defined as “the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial was concluded according to the prespecified protocol or was terminated.”
The general provisions for basic results reporting can be found at: https://prsinfo.clinicaltrials.gov/FDAAA801BasicResults.pdf and additional information is posted on https://clinicaltrials.gov/ct2/manage-recs/fdaaa
The current DRAFT definitions related to ‘applicable clinical trials' represent the best current thinking on the definitions (https://prsinfo.clinicaltrials.gov/ElaborationsOnDefinitions.pdf).
Please review to see if your trial would be considered an "applicable clinical trial" under the law. If so, results would be required to be included in the results section in a tabular format.
Additional helpful documents for including the appropriate data can be found on the PRS Information page at: httpss://www.clinicaltrials.gov/ct2/manage-recs/how-report.
See also:
Investigator's Login Page: https://register.clinicaltrials.gov
Investigator's Information Page: https://prsinfo.clinicaltrials.gov
Protocol Detailed Review Items: https://prsinfo.clinicaltrials.gov/ProtocolDetailedReviewItems.pdf
For further questions or more information about submitting study results, please write to: register@clinicaltrials.gov
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Keywords: clinical_trials,results