Tip of the Week Archive

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.

For Example, for Outcome Measure "Pain Scores at 2 Weeks":

• The Unit of Measure should be consistent with the Outcome Measure description and title (i.e., "Scores on a scale" in this case).
• The Measure Type should be appropriate to the type of data (for aggregate scores being reported here, this should be a measure of central tendency, e.g., mean, median, etc., with a measure of dispersion/precision).
• The outcome measure data should accurately reflect the aggregate data collected for this measurement.

Acceptable Example:

However, sometimes we see non-meaningful placeholder data entered. The two most common types are:

1) The Measure Type being entered incorrectly as "Count of participants", and the number of participants in each arm being reported in the data table, rather than the actual measurement data.

Unacceptable Example: Nonmeaningful Count of Participants entered

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).

Unacceptable Example: Zeroes entered in place of actual data

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.

If that's the case, don't worry: we are here to help you navigate these hurdles! If you have questions about entering results, or if you'd like one-on-one assistance, contact [email protected].