On Thursday, April 6th, the ClinicalTrials.gov team announced changes that are scheduled to go live on April 18, 2017, to support the Final Rule compliance date.
Final Rule Compliance Date
This release of the PRS makes the newly required data elements described in the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) mandatory for certain studies. Specifically, registration and results information must include the new data elements if the Study Start Date or Primary Completion Date, respectively, is on or after January 18, 2017. Since the January 18, 2017 release, these data elements have been marked with a WARNING message if missing. They are now marked with an ERROR message if missing. For more information on these data elements, refer to the January 18, 2017 entry in this document and the data element definitions documents for Interventional and Observational Studies, Expanded Access, and Results.
This release also adds validation rules to assess consistency across certain data elements, including U.S. FDA-regulated Drug Product, U.S. FDA-regulated Device Product, U.S. FDA IND/IDE, Product Manufactured in and Exported from the U.S., Intervention Type, and Facility Information. Validation rules were also added to improve the accuracy of location information provided in the Facility Information data elements (City, State/Province, Country).
PRS Review Comments
All PRS Review Comments provided after this release will be labeled as either Major Comments or Advisory Comments. While each Major issue identified in the comments must be corrected or addressed, Advisory issues are suggestions to help improve the clarity of the record.
The Corrections Expected date column has been added to the Planning Report. This date indicates when Major Comments described in PRS Review Comments for the study record must be corrected or addressed. The new field has also been added to the Record Information Download API.
The approach to FDAAA Status has been modified. With this release, only studies with a Study Start Date on or after January 18, 2017 can be labeled “ACT” for applicable clinical trials. This label indicates that the information provided for a study is consistent with the definition of an ACT that is required to be registered under 42 CFR Part 11 and as described in the ACT Checklist. Studies with a Study Start Date before January 18, 2017 will continue to be labeled “pACT” for probable ACTs, as appropriate, based on the information provided. A new FDAAA Status of “Unknown” will be used when the information provided is insufficient to label a study (e.g., during the process of data entry). Other minor changes were made to how FDAAA Status is determined, such as adding the new “Combination Product” Intervention Type to the pACT conditions (if used).
Note that these labels are intended to be tools and are provided for informational purposes only. Ultimately, the responsible party must evaluate whether a specific trial is an ACT subject to the requirements of FDAAA or the final rule.
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