My condolences. :)
I'm very old school when it comes to clinical studies, so I would never even think of using EDC for a study this small. Maybe not a CRO, either, but you didn't ask about that.
Class I, II, III device?
What kind of study is this? EFS, pivotal, to support clearance, labeling change/new marketing claims? IDE? Abbreviated IDE? ISO 14155? How many sites?
How many is "a few"? 4-5? 8-10?
Are the "data" qualitative or quantitative?
Regardless, do yourself a big favor and join ACRP for $160. I don't think any company should sponsor a clinical trial of an FDA-regulated product without at least one ACRP member in the company. ACRP has a forum too. I haven't been a member for 3-4 years now, but they used to have a small but active medical device subforum, with some very knowledgeable people.
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 17-Sep-2020 19:56
From: Anonymous Member
Subject: EDC vs paper CRFs; small med device study
This message was posted by a user wishing to remain anonymous
Hello!
I have previously had the pleasure of working with in-house, well-established clinical study departments but now I'm working with a small medical device company who is planning to work with a CRO. The study is observational, during use of the device only, no follow up visits, and a small number of data points to be collected for a small scale study, on the order of 100 subjects.
Management is having serious sticker shock with the quotes received related to EDC, which are over $25K, so the company is leaning toward paper CRFs. What are the trade-offs to consider? And what are the appropriate record-keeping requirements for the CRFs - scanned signed and completed forms?
I appreciate any advice and insights.
Thanks,
Anon