The regulations at 42 CFR 11.48(a)(5) require a copy of the protocol and Statistical Analysis Plan (SAP) (if not included in the protocol) to be submitted with clinical trial results information for any Applicable Clinical Trial (ACT) with a Primary Completion Date on or after January 18, 2017.
Incorrect reporting of study Arms due to duplicate counting of participants is a common “Major Issue” cited by PRS reviewers. If you have counted individual participants in more than one study arm, you’ll receive a Major Issue QC comment.
Have you received a message that your ClinicalTrials.gov record needs attention, but everything was fine the last time you checked? The problem might be due to your Study Status module being out of date.
For clinicaltrials.gov purposes, the number of participants in the Protocol Enrollment data element must match the number of participants in the Started element for the first Period in the Participant Flow module, or an explanation must be provided.
When entering Outcome Measure results data, you will need to select a Measure Type to indicate the kind of data you are reporting in the table. For example, is this number a mean? Is it a count of participants? Is it a Number, like a score? If entered incorrectly, you'll receive a validation error, or a QC comment.
Example Studies for Results Data Entry are available on the ClinicalTrials.gov Training Materials webpage. These fictional study records show key concepts for registration and results data entry for various study designs.
If an Outcome Measure title and description do not contain enough information for the general public to understand the measurement, PRS will reject the record. To address this, edit the Outcome Measure so that it thoroughly describes the measurement in non-technical language.
In a protocol “Outcomes” might be described more like study aims. However, for ClinicalTrials.gov purposes, Outcome Measures must be single measurable variables. This is what we mean when we say that “Outcome measures must be measurable outcomes”.
ClinicalTrials.gov records are required to be updated periodically, and when information in the record changes. If your IRB has approved a protocol amendment, be sure to check the information in your ClinicalTrials.gov record and update it with any relevant changes within 30 days of the amendment approval.
On August 12, 2020, FDA issued a final guidance document clarifying when and how FDA intends to seek civil monetary penalties for noncompliance with the ClinicalTrials.gov registration and results reporting requirements for Applicable Clinical Trials (ACTs).
Responsible parties must now submit results data to ClinicalTrials.gov for any Applicable Clinical Trial (ACT) that:
1) was initiated after September 27, 2007, or was ongoing as of December 26, 2007;
2) reached its primary completion date (i.e. the last study visit where you collected data for your primary outcome) before January 18, 2017; and
3) studied a product that is approved, licensed, or cleared by FDA at any time, including after the ACT’s primary completion date.
When entering results data for crossover studies, Arms/Groups typically need to be presented one way when entered into the Participant Flow and Baseline Characteristics modules, and then another way when entered into the Outcome Measure Data and Adverse Events modules.
The regulations require certain clinical trials be registered within 21 days of enrollment start, but NIH and journal policies are more stringent. Generally, you should register your study BEFORE beginning enrollment to comply with those policies.
The Primary Completion Date and Study Completion Date are NOT connected to Data analysis, Publication, Enrollment completion, or IRB closure. They are based on the last study VISIT dates where you collected data for your outcome measures.