Doug Bain, Chief Technology Officer at KCR
For over 20 years, the clinical research industry has been seeking to phase out data transcription from paper or EHR systems into an EDC systems eCRFs. The ability to enter data either manually or electronic directly into an eCRF is referred to as recording data as eSource.
Many of us who have worked in the industry can relate stories of running eSource only studies. I was involved in 49 specific eSource only clinical trials between 2000 and 2002 using early tablets and wifi. This worked at the time because we had controlled access to a defined, enabled set of sites. When this is not the case, we have a number of challenges.
That said, there are no insurmountable regulatory constrains in entering data into suitable EDC systems directly.
The primary reasons we don’t see this today is that
a). one size does not fit all and
b). most EDC systems do not provide an environment meeting regulatory guidance.
Each site is different. Each country is different. Many sites have EHR systems that are used across departments with integrated lab data management. Not every EHR system is capable of feeding data to an EDC system.
If a sponsor is running a study and seeking patients, the fact that a site is unable to provide eSource is rarely a reason that blocks working with that site if they have eligible patients.
However, we do have a catch. Sponsor (or CRO) controlled EDC systems.
In 2013, the FDA issues guidance clarifying their position on eSource.
The bulk of the content of this guidance describes how the majority of sites with EDC solutions are capable of capturing eSource data. However, the following clause has created interpretation challenges;
The clinical investigator(s) should retain control of the records (i.e., completed and signed eCRF or certified copy of the eCRF)
Some vendors have made a meal of this by producing complex physical data separation with one copy only being accessible to the site and the other the sponsor. However, I believe in a properly architected system, this is unnecessary.
The game changer is the introduction of ‘trusted 3rd party’ solutions that provide an environment that supports a level of autonomy for the investigator sites allows investigator sites to ‘control’ the eSource data.
Many EDC systems today, in particular the legacy solutions provide Sponsors or CROs with ‘control’ over the roles, permissions and access to eCRF data. This means that they are able to relinquish control of eSource data from the sites in traditional EDC products and therefore clashing with the FDA’s guidance noted above.
So — in short, if you wish to capture eSource data, and be compliant with FDA guidance, then you need to be prepared to implement or architect a trusted 3rd party eClinical solution.
Many ePRO and DCT vendors work to a trusted 3rd party model to some extend. Unfortunately, they have rarely managed to deliver effective EDC and therefore cannot stake a claim for being eSource site friendly.
I hope to share additional information on what I would deem an adequate trusted 3rd party system.
Patient solutions — the catalyst for change
Supporting sites with eSource may not be the end game. If we take this level of stakeholder autonomy further, we can extend this model to meet a requirement for patients to be in a position to control the sharing of their data with sites and onto sponsors.
More on that in a later post…
*This blog was originally published on LinkedIn on July 11, 2022*