Tip of the Week Archive

Nov 12, 2020

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.

Nov 5, 2020

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.

Oct 29, 2020

Here are three example Outcome Measures with results data properly entered.

Oct 22, 2020

How you close out a record for a completed or terminated study will depend on whether or not you are required to report results to ClinicalTrials.gov.

Oct 16, 2020

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 The problem might be due to your Study Status module being out of date.

Oct 8, 2020

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.

Oct 1, 2020

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.

Sep 24, 2020

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.

Sep 17, 2020

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.

Sep 10, 2020

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”.

Sep 3, 2020

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.

Aug 27, 2020

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).

Aug 20, 2020

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.

Aug 13, 2020

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.

Aug 6, 2020

Entering keywords correctly in your ClinicalTrials.gov record can help potential participants find your study.

Jul 30, 2020

A Common PRS “Major Issue” that will cause a record to be rejected is if an Outcome Measure Time Frame 1) includes more than one time point AND 2) isn’t measuring a change between those time points.

Jul 23, 2020

We get it, study teams change! When that happens, access to ClinicalTrials.gov study records has to be changed manually.

Jul 9, 2020

The Outcome Measure "Time Frame" is the specific time point (e.g. study visit) when you are collecting the outcome measure data, not the overall duration of the study.

Jul 2, 2020

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.

Jun 25, 2020

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.