Case record form (CRF) is a wonderful and necessary tool used in clinical trials to collect data from each participating patient. CRF (also, referred as case report form) have historically been on paper (unlike electronic ones these days). Traditionally, something like carbon copy paper have been used, such that one sheet can be added to the Trial Master File (TMF). Paper CRFs are still being used within smaller studies or studies in some geographies. But, mostly, there is a push and inclination to use electronic CRFs (eCRF) or electronic data capture (EDC) in larger / global studies 1,2.
What are the advantages of electronic data capture (EDC) or eCRF?
Some are listed below 1,4,5,6. Do you want to add more?
- Easy availability of data – Trial teams, monitors and auditors can review the data, wherever and whenever they might want to.
- Inbuilt plausibility to ensure appropriateness of data – Predefined checks can be placed to ensure that data entered is appropriate.
- Faster accumulation and transfer of data – Particularly from external devices, leading to reduced data entry time
- Easy sharing and exchange of information – Data and the progress on its capture, processing and acceptability can be easily shared with relevant personnel.
- Real Time Automated Edit Checks – Clearly a big advantage over paper CRFs.
- Facilitate Analysis – Data collected in eCRF are linked with one form to another from for analysis.
- Rapid formal reporting – Authorized personnel can access, download and print status reports any time throughout the study and on completion.
- Unlimited security possibility – Any level of security in storage and access systems can be built.
- Higher data quality – increased statistical power
- PRO readiness – Ability to work seamlessly with PRO
An excellent presentation from Liora Bosch of Omrix Biopharmaceuticals, a J&J company, provides a great case for eCRF utility, key considerations and challenges.
What are common EDC systems available in the market?
There are different kinds of EDC systems developed by various companies and more are still coming up.
Somewhere in the western world, a clinical trial team of an organization was looking to buy an electronic data capture (EDC) system for their clinical trial projects. There were many choices in the market and efforts were on to seek feedback on previous experiences with these products. One of team members got an interesting thought to seek this feedback quickly and much more reliably. Why not ask other clinical researchers on a social media group? This generated a pool of responses containing unbiased feedback of user experience with currently marketed EDC systems.
Here are some of the known EDC systems in the market.
- Rave from Medidata
- Inform from Oracle
- Oracle RDC from Oracle
- nowEDC from Datatrial
- Datalabs EDC from Perceptive(Subsidiary of Parexel)
- Macro from Elsevier
- QDS EDC from QDS
- Data Trak EDC from Data Trak
- TrialMaster from Omnicomm
- Encapsia from Cmed
- IBM EDC from IBM
- Target Health EDC from Target Health
- Veeva Vault EDC from Veeva
- eCaseLink from DSG
- Medrio EDC from Medrio
- Captivate EDC from clinCapture
- REDCap EDC from REDCap Cloud
- Nukleus EDC from TCD eClinical
- Bioclinica EDC from Bioclinica
- Castor EDC from Castor
- iMedNet EDC from MedNet
While, most of these EDC systems bring advantages suggested earlier, their acceptability in the market differ significantly.
User experience – Key factor in acceptability of eCRF systems
User experience – the overall experience of a person using a product e.g. EDC or eCRF, especially in terms of how easy or pleasing it is to use, drives a user to like or dislike that product.
It generates perceptions of system aspects such as
- ease of use and
for that particular user.
This means, that the acceptability of a product, including EDC systems, can be a sum-total of various aspects of human–computer interaction and product ownership.
For a product, like eCRF / EDC, user experience becomes more crucial, with timely submission, review and stringent data acceptability requirement in clinical research.
An EDC system needs to be easily taken up, understood and utilized fully by the user. Learning curve should be acceptable and not too steep.
Clinical researchers are aware and the word spreads fast
Considering the complexities of clinical trials, most of the users in the industry undergo a very fast realization of how user-friendly a system is. With a need to use these systems quite frequently by different kinds of users – clinical study coordinators, investigators, clinical trial monitors etc to name a few, any product is likely to generate an impression rather quickly.
What becomes more interesting is how this impression spreads across the industry.
Any prospective buyer (clinical research organization or a trial sponsor) is likely to take feedback from various resources before opting for their best choice. Some of these resources could be
- Past experience of employees
- Feedback from friends, ex-colleagues and associates of employees
- Online reviews of products
- Live demonstration of products
- Sponsor requirements
It’s enough to say that a good product is expected to gain a favorable word going around, rather quicker than a not-so-good product getting an unfavorable one. Thus, tapping the impressions of users as they come, is of great importance.
Story of a user – initiated survey on EDC
Somewhere in the western world, a clinical trial team of an organization was looking to buy an electronic data capture (EDC) system for their clinical trial projects. There were many choices in the market and efforts were on to seek feedback on previous experiences with these products.
One of team members got an interesting thought to seek this feedback quickly and much more reliably.
Why not ask other clinical researchers on a social media group?
LinkedIn, Facebook and other social media have become virtual community centers for people. They are not only able to stay in touch with their friends, colleagues and known persons, but can connect with various other (unknown) people with similar interests by joining a social media group.
Within clinical research too, there are various groups formed to share information, knowledge and, very often, a smile.
On a fine evening, one such group received a question from a group member – “What is the best EDC system you’ve ever used?”.
This question generated a flood of responses from many group members. Many people shared what they thought was the best EDC system. A lot of them shared their experiences with such products with more elaborated comments.
Series of responses received for this survey generated a pooled unbiased feedback on various marketed EDC platforms and eCRF systems. Considering the importance of early understanding of user experience, this feedback could be very interesting for clinical researchers, as well as developers of such EDC systems.
Results of the survey
An analysis of responses received for this survey was performed. All products commented upon by the users were listed down. Responses / comments / feedback on these products were also listed down and classified into 3 categories.
- ‘Select’ : Number of responses that suggested a positive feedback about the product were listed in this.
- ‘Reject’: Number of responses that suggested that user rejects the product were listed in this category.
- ‘Detest’: Number of responses that suggested that user disliked the product to a greater extent that just rejection, were included in this category.
A total of 207 responses were received at the time of preparation of this article. Here is the result of the analysis performed using above referred categories.
As evident here, rave from Medidata and Inform were the two products preferred by majority of respondents. Roughly half of the responses indicated a favorable view about Medidata. While, more than 30% responses favored Inform.
There were some negative responses as well, which was expected. But, it’s interesting to note that Rave and Inform had negligible numbers of negative responses.
Oracle RDC was the only product that had more negative responses than the positive ones.
Results of another survey on EDC systems other than Rave
Independent of above referred survey, another survey was also performed by a different user to find recommendations on products other than rave. Since Rave stood out as an undisputed winner among the respondents in earlier survey, findings of the second survey becomes important to assess the second choice for an eCRF system.
Inform again stood out as the clear choice of EDC platform, if Rave is not considered by the users. Among a total of 93 responses, there were 44 positive responses for Inform, nearly 50%.
However, it is also interesting to note that second choice of users after Inform, is Oracle RDC here.
Rave and Inform – two best EDC platforms in the market
Based on these two surveys, it is apparent that Rave and Inform are preferred by most of the users in the industry.
Rave has been an undisputed user in the market for long. It has been taken up for use in clinical trials by many big pharma and CROs.
However, it is hard to put Inform at second rank, given the reported fact 3 that it has more successful submissions to the FDA than any other EDC system – including Medidata Rave.
What are your thoughts / comments / questions on best EDC systems in the market?
Do you or your organization use EDC? If yes, share with us your feedback on the EDC system of your choice.
Or, if you have any questions, let’s discuss about it.
Share your comments, questions or feedback on this survey.
- What is an eCRF in clinical trials? – Illingworth Research Group
- Case report form – Wikipedia
- Inform Electronic Data Capture (EDC) and Data Management System
- Key Considerations and Challenges of EDC in the Implementation and Statistics of Clinical Trials – Presentation by Liora Bosch
- Comparison between paper CRF and eCRF | ClinZen Clinical Trial Blog
- Mobile electronic versus paper case report forms in clinical trials: a randomized controlled trial