Regulatory Open Forum

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

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.


------------------------------
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

Paper CRFs are still the norm for many small trials. This means, in addition to HSPs and GCP, the sponsor (data management center) is intimately involved with data integrity issues and must understand not only ALCOA requirements but also concepts like double enter/ verify processes to build an excel database to house the data. Issues like scanning the CRF are peripheral to the main concerns about accuracy of data being entered into the tools like Excel: used to analyze the data. Yes, the other original paper CRFs should be retained unless you use a validated prices to scan them (this step is not needed since paper CRF is acceptable as written as long as the paper copy can be produced for inspection). The real issue is to ensure the paper CRF copy, just like any e-CRF, matches the source document exactly.

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Sent from my iPhone


Original Message:
Sent: 9/19/2020 3:48:00 AM
From: Julie Omohundro
Subject: RE: EDC vs paper CRFs; small med device study

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.

What kind of study is this? EFS, pivotal, to support clearance, labeling change/new marketing claims?  IDE? Abbreviated IDE?  ISO 14155?  How many sites?

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.


------------------------------
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

My answer would be that it could depend on the purpose of the study and the amount of data being collected. Because, if you don't want to pay the upfront cost of EDC you could still end up paying for data entry and a higher risk of errors. The rationale for EDC is that data gets entered once. With paper CRFs, the investigator enters the data on the CRF and then, following any standard for data reliability (industry or academia), double-key data entry. So, you are paying three people to enter data into the database - and creating three opportunities for data errors. 

So, depending on the purpose of the study and the risk tolerance of the company, you could choose to take shortcuts and reduce the cost. However, when I have seen cost comparisons between paper CRFs and EDC in the past, it was pretty much a wash. If your company intends to use the data for regulatory purposes, I would highly recommend doing that analysis before making the decision.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

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