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eCF Members Audit Trail Review Survey
eCF Members Audit Trail Review Survey
Audit Trail Survey
THIS SURVEY IS NOW CLOSED. FOR RESULTS, PLEASE CONTACT WEBMASTER3@ECLINICALFORUM.ORG.
1. Has your company successfully implemented an Audit Trail Review process using the use cases from the eCF Audit Trail Review (ATR) Paper?
Yes
No
If NO, what are your current challenges?
If YES, is the process
Fully automated
Partially automated
2. What software is being used to analyze the data?
3. Is the software in-house developed or off the shelf?
In-house developed
Off the shelf
4. Did you use all the use cases or some of the use cases?
All of the use cases
Some of the use cases
5. If you used some of the use cases which ones were the most important?
6. How are you receiving the audit trail data from the Suppliers?
7. If a supplier has over 100 of your studies, are you taking a sampling of studies? Or all the studies?
Sampling of studies
All studies
How is the sampling size determined?
8. What is the frequency of Audit Trail Review assessment? (monthly, quarterly, yearly)
Monthly
Quarterly
Yearly
9. Are any of your current Suppliers performing Audit Trail Reviews on your studies?
10. What type of systems (e.g., EDC, eCOA, etc) are you currently doing Audit Trail Reviews on?
EDC
eCOA
Others
11. Have you had a recent inspection where the ATR was requested?
Thank you.
The responses to this survey will be presented and discussed at the eCF Spring 2024 workshops and will also be made available via the eCF website Members area.