Tip of the Week Archive

Jun 18, 2020

If your Outcome Measure will be assessed using a score or a scale, ClinicalTrials.gov requires that the Outcome Measure description include specific information. Use this template to write an acceptable Outcome Measure description for a measure assessed using a score or scale.

Jun 11, 2020

When writing your Outcome Measures in a ClinicalTrials.gov record, follow this checklist to avoid QA comments and delays in publication.

May 28, 2020

Watch out for these common problems that may cause ClinicalTrials.gov’s PRS staff to reject your study results data submission during QA review:

May 21, 2020

Use this table to prepare your Outcome Measure data for entry into the Clinicaltrials.gov tabular results modules.

May 14, 2020

How to address a common ClinicalTrials.gov QA comment: “Major Issue: The Measure includes a scale. Please provide the following scale information…”

May 7, 2020

The number of participants Enrolled is the number of participants who agreed to participate in the study following completion of the informed consent process. The number of participants Started, is the number of participants who were assigned to an Arm/Group. If the “Enrolled” and “Started” numbers differ, provide an explanation in the Pre-assignment Details data element.

Apr 30, 2020

What Happens when a ClinicalTrials.gov Record Owner Leaves their Position? PIs must transfer their ClinicalTrials.gov records with them when they arrive at or depart from the institution.

Apr 23, 2020

Data Elements in the Participant Flow Module Infographic

Apr 16, 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.

Apr 10, 2020

Include “COVID-19” in the Brief Title for SARS-CoV-2 & COVID-19 Related Studies NLM has requested that Record Owners conducting SARS-CoV-2 and COVID-19 related trials include “COVID-19” in the Brief Title of the ClinicalTrials.gov study record. This should be done even if the study’s official title does not include “COVID-19” (the official title will still be entered in the Official Title field, in these cases).

Apr 2, 2020

ClinicalTrials.gov Study Status Changes due to COVID-19 Outbreak If research activities are halted to any extent during the COVID-19 outbreak, update the ClinicalTrials.gov record to reflect the current Study Status: