ClinicalTrials.gov Major Comments

The table below contains the complete list of major comments that may be provided to the responsible party by National Library of Medicine staff during the quality control (QC) review conducted to identify apparent errors, deficiencies, or inconsistencies in a submitted study record. The responsible party is required to address all major comments.

For more information on the QC review process, see the PRS User's Guide Section 6: PRS Review Process

Major Comments
A free-text field appears to include results data or conclusions drawn from the data. All results data must be reported in a tabular format.
A measure of dispersion or precision appears missing for continuous data.
Changes made during Quality Control Review need to be verified by the responsible party.
Data reported here appears invalid.
Eligibility Criteria appear to be missing.
Information here appears inconsistent with information in other parts of the record.
Information in other parts of the record suggests that adverse events were collected that are not reported here.
Information in the record appears inappropriate for posting on ClinicalTrials.gov.
Information in the record suggests that Serious Adverse Events are not reported separately from Other (Not Including Serious) Adverse Events.
Information in the statistical analysis appears inconsistent with outcome measure data.
Information provided does not appear sufficient to evaluate whether there is good cause for an extension.
Information related to the payment of participants appears to be included. Payment information is not permitted in the record.
Information within the Adverse Events module appears inconsistent.
Information within the Participant Flow module appears inconsistent.
Information within the measure appears inconsistent.
Information within the statistical analyses appears inconsistent.
Issues noted on a previous submission of this record do not appear to have been addressed.
Locations do not appear to be listed separately.
More than one baseline or outcome measure appears to be described, and it is unclear which measure the reported data represent.
More than one outcome measure appears to be described.
One or more numbers in the table appear to be nonmeaningful placeholders that do not reflect data collected during the study.
One or more of the baseline measures appear to be used inappropriately. Required data may be missing.
One or more of the uploaded PDF/A documents appear inappropriate for the study described in the record.
One or more of these comments also apply to other arms/groups in the record.
One or more of these comments also apply to other measures in the record.
One or more of these comments also apply to other parts of the record.
One or more of these comments also apply to other statistical analyses in the record.
Participants appear to be counted more than once within a row.
Required information appears to be missing.
Results data or conclusions drawn from the data appear to be included. Results data or conclusions are not permitted in the Protocol Section.
Results information appears incomplete.
Some information appears inappropriate where reported.
Some or all of the content does not appear to be in English.
Specific comments are not provided because the record appears to have many significant errors, deficiencies, or inconsistencies.
The Adverse Event Reporting Description does not appear to explain why the Number of Participants at Risk is zero.
The Arm Type "No Intervention" appears inconsistent with other information in the record.
The Enrollment number appears inconsistent with information in other parts of the record.
The FDA Application Number(s) appears inaccurate.
The Intervention Name(s) does not appear sufficiently descriptive.
The Measure Type appears inaccurate.
The Outcome Measure Title and Description appear inconsistent.
The Outcome Measure Title does not appear to provide sufficient information to understand what is assessed.
The Outcome Measure Title does not appear to provide sufficient information to understand what will be assessed.
The Study Type appears inconsistent with information in the record.
The Time Frame appears inconsistent with information provided here or in other parts of the record.
The Time Frame appears to contain more than one time point. Each time point should be reported in a separate measure.
The Time Frame does not appear specific or in the correct format.
The Time Frame, or information elsewhere, appears to contain more than one time point. It is unclear which time points are reported or how they were combined.
The Type and Number of Units Analyzed appear to be used inappropriately.
The Unit of Measure appears inconsistent with the Measure Title, the Measure Description, or both.
The Unit of Measure appears invalid.
The arms/groups appear inconsistent with information in other parts of the record. Each arm/group should be described separately, or a valid explanation provided.
The arms/groups appear inconsistent with information in the record.
The baseline or outcome measure includes data that appear to have more than one unit of measure.
The description of the scale or categories does not include sufficient information to understand the results reported.
The explanation provided is not sufficient to understand why one or more values are not available.
The measure does not appear to include sufficient information to understand how outcomes are measured and reported.
The measure does not appear to include sufficient information to understand what will be assessed.
The number of participants analyzed appears inconsistent with data here or in other parts of the record.
The number of participants appears inconsistent with the number of participants enrolled in the study.
The number of participants at risk appears inconsistent with data here or in other parts of the record.
The participant flow appears to include insufficient information to understand how units or participants were assigned to arms/groups, the intervention strategy used in each arm/group, or how units or participants progressed in the study.
The participant flow appears to include insufficient information to understand the arms/groups to which participants were assigned, the intervention strategy used in each arm/group, or how participants progressed in the study.
The record appears to have been submitted by an entity or individual who is not the responsible party.
The record contains one or more system validation errors that must be corrected.
The statistical analyses do not appear to include sufficient information to understand the data reported.
The study does not appear eligible for registration on ClinicalTrials.gov because it does not evaluate a health or biomedical outcome in human participants.
There does not appear to be sufficient information to understand the Time Frame.
This record appears to duplicate another record submitted to ClinicalTrials.gov.
This record has new issues that must be addressed.
Units appear to be counted more than once within a row.