This past week I received a question from a viewer regarding electronic data capture (EDC). I have pasted the question in its entirety below.
I really like you videos and thank you for the immense knowledge you are sharing. I have a topic which I want you to make a video on.
Can you elaborate more on EDC. I have seen One of your videos which gives a brief idea of what EDC is, but can you elaborate the video in the Data Management Team and Clinical Project Management prospective.
I would like to know:
- Do clinical sites have their own laboratory to perform blood/urine etc. tests? If they get the tests done elsewhere, how are the results entered into clinical site’s database?
- Can you elaborate more on manual CRF and eCRF? I want to know how eCRF is prepared by Clinical Project Managers.
- Does HITECH Act, Certified EHR, Meaningful Use has any influence on clinical sites?
- What types/brands EDC software’s are available for use at the clinical sites? Are these EDC software’s certified EHR’s? (as required by HITECH Act)?
- How is the migration of the clinical data done from clinical site to central database at CRO/Sponsor?
- Every Clinical Study is different and the clinical data collected is different based on the tests the subjects undergo. If you use a SAME software that collects clinical data for all the studies, how is specific data migrated to specific individual study sponsor?
- During the site qualification process, what does study sponsor look for? Especially EDC related stuff?
- If central database at CRO is developed on Oracle and the EDC systems that are used in clinical sites will be 100 different varieties. How are all these softwares integrated to transfer the clinical data in a proper format?
Any additional info on EDC would be relly helpful. Thank you
I really did try my best to answer these questions and I hope that this video on electronic data capture in clinical trials can better clarify my other video on this topic here.