Major Issue: Results Data "Appears to be Nonmeaningful Placeholders"
Addressing ClinicalTrials.gov Comments
Jun 30, 2022
When reporting Outcome Measure results data to ClinicalTrials.gov, the numerical data that you enter in to the data tables must accurately reflect the measurement you described in the Outcome Measure title and description.
Acceptable Example: |
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However, sometimes we see non-meaningful placeholder data entered. The two most common types are: |
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2) Zeroes are entered in the data table, but it's clear that this doesn't reflect the actual data values (often, we see this happen if data is missing or was not collected for one or both arms). |
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ClinicalTrials.gov will always reject nonmeaningful placeholder data with the following comment: Major Issue: One or more numbers in the table appear to be nonmeaningful placeholders that do not reflect data collected during the study. Often, this issue arises if the study team is having trouble navigating the results data entry system, or if the results data is not readily available to enter. |