Tip of the Week Archive

Per the regulations, where required, all primary and secondary Outcome Measures must be registered within 21 days of enrollment of the first subject (prior to enrollment, if you plan on publishing), and if those Outcome Measures change, the record should be updated within 30 days of IRB approval. However, mistakes happen, so what if you’ve reached the end of your study, and you are required to report results, but your Outcome Measures in your ClinicalTrials.gov record don’t match up with your protocol and the data you actually collected? 

In general, your goals will be:

1. To report all Outcome Measures that are listed as Primary or Secondary Outcome Measures in the protocol, and
2. To explain any discrepancies between the initial registration and current Primary and Secondary Outcome Measures, to avoid the appearance of reporting bias. 

• Minor wording differences between the protocol and the Outcome Measures in the record are acceptable.
• If any Outcome Measures were not collected, don’t delete them. Instead, report 0 participants analyzed in each arm when entering the Outcome Measure data, and explain in the “Analysis Population Description” field why that Outcome Measure data was not collected (e.g. because the Outcome was removed via a protocol amendment, the data could not be collected, etc.)
• Remember, if you collected Outcome Measure data, it must be reported. “No statistically significant difference” or similar is not a valid reason to not report the data. 
• Any Outcome Measures that were added after registration should be added to the record.
• Tip: Consider adding an explanation to the Outcome Measure Description saying "This Outcome Measure was added via a protocol amendment in [month/year]".

If you suspect that you may need to revise your Outcome Measures so that they match your protocol, don’t wait! Log in and update your record today (Organization is UColorado and your email is your username). For help, contact clinicalresearchsupportcenter@ucdenver.edu.