I’ve Received an Email Asking About My Final Study Visits…What Gives?Jun 3, 2021
The Clinical Research Administration Office at CU is currently undertaking a large-scale quality control review of ClinicalTrials.gov records. If you are a record owner (P.I.) of a record that meets certain criteria, we have contacted you to request the following:
- The Anticipated (if your study is ongoing in our records) or Actual (if our records reflect that you’ve reached your final study visit) last study visit where you did or will collect outcome measure data for your PRIMARY study outcome measure(s).
- The Anticipated (if your study is ongoing in our records) or Actual (if our records reflect that you’ve reached your final study visit) last study visit where you did or will collect outcome measure data for your PRIMARY or SECONDARY study outcome measure(s) (this may be the same date as above).
Based on the feedback we’ve received, we’ve assembled a quick FAQ for you below:
My study is still enrolling and I don’t know when my final visit date will be. How should I answer?
- For anticipated dates, a month/year are fine. If that’s still vague, use a good check-in point when you might have a clear idea of those final visit dates. These dates can and should be updated as needed as the study progresses.
I don’t have “Study Visits” for my study. How should I answer?
- We realize that the term “Study Visit” may not apply to all studies. To clarify, we’re looking for an estimated or actual date of your last interaction with your last participant (including surveys, phone calls, etc.) for the purposes of data collection for your 1) Primary and/or 2 Primary and Secondary outcome measures. If your primary/secondary outcome measures are based on observational chart review, use the last date you will or did go into a chart to collect data. The key point here is that we’re looking for final dates of data collection, not data analysis.
Does this email mean I’m in trouble?
- No, but it is important that you provide these dates as soon as possible so that we can verify that your record is current and that you are not at risk for any corrective actions. If we discover any outstanding issues during this process, we will contact you separately for resolution.
Why is this being done/why is it urgent?
- Fundamentally, to mitigate risk to our researchers and to the University. University leadership has prioritized more proactive communications and support of our faculty. In order to implement this, we must quickly confirm that our records are accurate. The information we’ve requested reflects the Primary and Study completion dates as ClinicalTrials.gov defines them. We’ve discovered that there seems to be significant confusion related to these fields, so we are going through these records and confirming the dates are correct. Our next step will be to run reports based on these dates and reach out with reminders and assistance in closing completed records and, where required, entering results data.
We appreciate your help with this important compliance undertaking. Additionally, we apologize if responses to individual questions are delayed as we process the incoming data.