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.
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.
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.
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).
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: