prsinfo.clinicaltrials.govClinicalTrials.gov Final Rule (42 CFR Part 11) Information

Final Rule (42 CFR Part 11) Information This page provides general information about the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11). This page will be updated to provide more details on data submission requirements, including the formatting of certain types of clinical trial information required by the Final Rule. Receive notifications when new information is added by subscribing to the ClinicalTrials.gov Hot Off the PRS! email bulletin. The Final Rule clarifies and expands the requirements for submitting clinical trial registration and results information to ClinicalTrials.gov in accordance with Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801) . The Final Rule is intended to make it clear to sponsors, investigators, and the public which trials must be reported, when they must be reported, and whether compliance with requirements has been achieved. The effective date for the Final Rule is January 18, 2017 and the compliance date is April 18, 2017. Section IV.F. of the Final Rule (81 FR 65118-22) describes how the new requirements apply to the submission of clinical trial registration and results information, taking into consideration the Study Start Date and Primary Completion Date in relation to the Final Rule’s effective date. This page will be updated to provide more details on data submission requirements, including the formatting of certain types of clinical trial information required by the Final Rule. National Institutes of Health (NIH) News Release: HHS takes steps to provide more information about clinical trials to the public (September 16, 2016) Final Rule Webinar Series : View the archived content for the webinar series, designed to help responsible parties further their understanding of the Final Rule. FDAAA 801 and the Final Rule : View summary information about the requirements described in FDAAA 801 and the Final Rule, including linked references to key regulatory provisions and related discussions in the Final Rule. Checklist and Elaboration for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (PDF) (June 2018): Intended to assist users in evaluating whether a clinical trial or study is considered to meet the definition of an ACT, as specified in 42 CFR 11.22(b), and is subject to "expanded" registration requirements under the final rule. Information following the Federal Court decision in Seife et al. v. HHS et al. , 18-cv-11462 (NRB) (S.D.N.Y. Feb. 24, 2020) regarding the Submission of Results Information for ACTs Subject to the Registration Requirements and Completed Before January 18, 2017 (July 28, 2020) Letter to Responsible Parties (PDF) (July 2020): View letter providing notice of the recent Federal court decision FAQs: View Frequently Asked Questions to provide clarity to responsible parties following the Federal Court Decision in Seife et al. v. HHS et al. , 18-cv-11462 (NRB) (S.D.N.Y. Feb. 24, 2020) Voluntary Submission Flowchart and Triggered Trials Checklist (PDF) (August 2018): Intended to help responsible parties identify voluntary submissions and triggered trials under section 402(j)(4)(A) of the PHS Act and 42 CFR 11.60. Frequently Asked Questions (FAQs) : View FAQs about the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11). Data Element Definitions : View the data element definitions documents, which describe the registration, expanded access, and results data items that are entered via the ClinicalTrials.gov Protocol Registration and Results System (PRS). PRS User’s Guide : Describes how to use the PRS to manage accounts, maintain records, and submit clinical study information to ClinicalTrials.gov, including step-by-step instructions for PRS functions. Support Materials : Includes links to help resources for entering and submitting clinical study information to ClinicalTrials.gov, as well as information on laws, regulations, and policies requiring registration and results reporting on ClinicalTrials.gov. Changes from Current Practice Described in the Final Rule : Summarizes changes in ClinicalTrials.gov and PRS requirements and practices for applicable clinical trials (ACTs) initiated on or after January 18, 2017. FDA Guidance: Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank (August 2020) Updates to the PRS: The Final Rule requires certain changes to the Web-based PRS, which is used by responsible parties to submit registration and results information to ClinicalTrials.gov. An overview of planned and implemented PRS updates that support the Final Rule requirements is provided below. January 18, 2017 (effective date): The PRS was updated to include new data elements specified in the Final Rule. In general, submission of these data elements was not required in the PRS until April 18, 2017. WARNING messages within the PRS helped responsible parties identify those data elements that would be required beginning April 18, 2017, but that had not been submitted. April 18, 2017 (compliance date): Submission of the new ("expanded") data elements are now required in the PRS for the following trials: "Expanded" registration information: Applicable clinical trials with a Study Start Date that is on or after the Final Rule effective date, January 18, 2017. "Expanded" results information: Applicable clinical trials with a Primary Completion Date that is on or after the Final Rule effective date, January 18, 2017. The new data elements for registration and results information are available for clinical trials with a Study Start Date or Primary Completion Date before January 18, 2017, even though the data elements are not required by the PRS for these trials. June 29, 2017: The PRS was updated to accommodate protocol and statistical analysis plan (SAP) document submission as described in 42 CFR 11.48(a)(5). Protocol and SAP documents must be submitted in the Portable Document Format Archival (PDF/A) file format. PDF/A is specified in International Organization for Standardization standard ISO 19005, and additional information on this format is available from the Library of Congress (see PDF/A, PDF for Long-term Preservation ). It is strongly encouraged that the PDF/A file also be consistent with the PDF Universal Accessibility (PDF/UA) file format. After responsible parties upload these documents into the PRS, the file format will be verified as PDF/A format. There is no support in the XML upload or the PRS API for submitting these documents. Note: The mechanism for submitting protocols and SAP documents also allows the optional submission of informed consent documents in PDF/A file format. Although not required by 42 CFR Part 11, the preamble to the Final Rule indicates that ClinicalTrials.gov will accept the final version of the informed consent document for posting. ( 81 FR 64999 ). Quality control (QC) review criteria and process (42 CFR 11.64(b)) On January 1, 2020, ClinicalTrials.gov will update posting procedures for submitted results information for applicable clinical trials. Consistent with 42 CFR Part 11, the National Library of Medicine (NLM) will publicly post submitted results information within 30 days of submission, regardless of whether the quality control (QC) review process is complete. November 5, 2019: Top Questions About the Updated Quality Control and Posting Procedures for ClinicalTrials.gov (PDF) were made available, addressing questions from the Updated Quality Control and Posting Procedures Webinar. October 15, 2019: Updated Quality Control and Posting Procedures Webinar held, describing the updated procedures and includes a question-and-answer session. For a recording of the webinar, slides, and questions and answers, see the Training Materials page. June 27, 2018: The ClinicalTrials.gov Protocol Registration Quality Control Review Criteria and ClinicalTrials.gov Results Quality Control Review Criteria were updated to...