CDISC held an eSource stakeholders meeting on March 18, 2016 during the CDISC interchange in Silver Spring, MD. The initial invitation said "During this initial meeting, we plan to discuss the charter and plans for this group as well as introduce members to each other and update the group on recent work."
The meeting was led by Michael Ibara, Head of Digital Healthcare at CDISC, and had 90 attendees from pharma, devices, regulatory agencies, EHR vendors, other vendors and other standards communities. Michael reviewed the current landscape including current guidances and the push from the FDA to pull data directly from the source. Many of the attendees came just for the eSource meeting and did not attend the interchange. Many people, especially at large pharma, said they are excited about embracing eSource and are looking for direction and leadership.
The term 'eSource' covers a lot of ground. eSource refers to pulling data directly from the patient record in the Electronic Health Record (EHR), having the site directly enter patient data into the EDC system as the data is obtained, or data coming from a lab, EKG or mobile device. The FDA would like to see data being submitted for consideration for regulatory approval to be as minimally manipulated as possible; therefore, direct from the source. In their Guidance for Industry: Electronic Source Data in Clinical Investigations, it states "In an effort to streamline and modernize clinical investigations this guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission."
We all agree that eliminating the need for transcribing data from paper into EDC is a good idea, yet many companies mandate that it be done exactly this way. In the past, there was a need for paper transcription when all patient records were paper-based, and the internet was less reliable. Today, most patient records are electronic, and sites have reliable internet; therefore, there is no reason to continue transcribing information from paper, except that it has always been done that way. It is time to reevaluate this archaic process and update the way data makes its way into the clinical database.
There are several good resources that outline the history, problem and current thinking related to eSource:
CDISC is looking to do for eSource what it did for standards - provide resources and support for sponsors to adapt its processes and embrace the use of eSource.
The eSource group will create a primer composing of several sections:
- Providence (data, process)
- eCRF (concept, implementation)
- System Validation/Privacy
- Economics/Cost Benefit
- Scalability Requirements (technical, regulatory, political)
I am super excited to be the team lead for the System Validation/Privacy section and would be interested in hearing any feedback related to this topic. I will be providing an update at SCDM in 'Session 16 - State of the Industry – eSource Initiatives' on September 14, 2016 from 8:30 – 10:00 AM EST.