February 18, 2019What's New
In October 2018, EMA issued a response to a Novartis request concerning eSource Direct Data Capture (DDC) qualification systems in clinical trials supporting Marketing Authorization Applications.
This is a very valuable document as it clarifies EMA's position on all direct data entry systems, including Target e*CTR® (eClinical Trial Record), Target Health Inc.'s patented web-based direct data capture system. Our only comment, which we will share formally with EMA, is that the eSource data do not necessarily need to be contemporaneously maintained in a commercial electronic medical record (EMR) or electronic health record (EHR), but rather in a human readable medical record, no matter how it is maintained, as long as it is under the independent control of the investigator.
The following are major agreed-upon concepts included in the EMA response .
1. Eliminating the manual transcription step from paper worksheets, which can occur today, is desirable.
2. eSource DDC refers to an electronic application and/or device that allows direct entry of source data, and to directly identify some of these data as CRF (Case Report Form) data, for clinical trial purposes at the point of care by investigator site staff, for example via an electronic tablet.
3. An essential element of the eSource concept is that the clinical assessment data and other source data is entered during the clinical visit in an eSource DDC system.
4. To be acceptable, an eSource DDC system and application should be customized in line with legal requirements and ICH GCP (Good Clinical Practices), validated, secure and maintained.
5. GCP requires that all entries, changes and deletions in a system are fully audit-trailed. This would also apply to an eSource system.
6. EDC systems already allow for direct data entry when defined and approved in the trial protocol. In this respect, the presented eSource system, therefore, is already to a wide degree covered by existing guidance.
7. Protocol related data should be under the control of and directly accessible at any time site/healthcare institution staff involved in patient care. Direct investigator's access to eCRF data should not be precluded in any way.
8. An increase of the investigator staff's workload must be avoided.
9. It is important to perform this benefit/risk evaluation both for data collected (mainly for the purpose of the clinical trial), and for data that will also be a regular part of the medical record of the patient.
10. Missing continuous investigator control over eCRF data is a frequent GCP inspection finding. As long as sponsor-independent source data exist and an audit trail is possible, at least a verification of the eCRF data against the sponsor-independent source data can be carried out in such cases.
11. The elimination of sponsor-independent source data would significantly affect data integrity and therefore, change the classification of these results from major to critical.
For more information about Target Health, contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Also visit the Target Health Eating Website to see all of the fantastic recipes since 2012.
Joyce Hays, Founder and Editor in Chief of On Target
Jules Mitchel, Editor