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Focus on Regulation

What the European Medicines Agency’s qualification opinion means for electronic clinical data capture

1.            Introduction

The European Medicines Agency (EMA) issued a qualification opinion following a request concerning proprietary eSource DDC (Direct Data Capture) technology. This technology allows the capture of clinical study source data electronically by investigator site staff at the point of care. In its opinion, EMA’s Committee for Medicinal Products for Human Use (CHMP) does not identify or support any specific, proprietary system. The Committee rather discusses and gives responses in relation to some of the characteristics a system for direct data entry should present. The general principles outlined in the opinion could be applied to different scenarios and to other eSource DDC technologies. Specific characteristics of different systems may require specific evaluation.

2.            Context of use of the eSource technology

eSource means any technology that allows the capture of clinical study source data electronically by investigator site staff at the point of care. This can be done using an electronic device, such as a tablet, or through an application. Source data at point of care is directly entered into an electronic form specifically validated to capture clinical data.

An eSource system can be considered an electronic data capture (EDC) system. eSource is an evolution of EDC, the current technology used by research institutions, sponsors and contract research organisations to manage clinical trial data. Currently, data from clinical assessments is initially captured on paper, and then transcribed into electronic case report forms (eCRFs). With eSource, the clinical assessment data is entered during the clinical visit, eliminating the need to transcribe into an eCRF, and allowing validations for the data entered to occur at the same time. According to EMA’s opinion, an eSource system has the potential to promote better data integrity and to render the data more legible, accurate, and timely.

3.            General considerations

The opinion provides recommendations regarding regulatory acceptability to use an eSource DDC in clinical trials conducted to support a marketing authorisation application for a medicinal product. The opinion provides that to be acceptable, an eSource DDC system should be customised in line with local legal requirements and with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)’s good clinical practices (GCP). Moreover, the system should be validated, tested for user acceptability, secure and maintained.

While GCP and data protection requirements apply, the opinion focuses on elements specific to a digital data capture system. Some fundamental aspects should be respected when designing the system:

  • the physician’s ability to record clinical information in the patient medical record should not be limited or constrained;
  • this information should be recorded in line with the current practice at the trial centre;
  • the integrity of the medical records should not be compromised;
  • the sponsor should have access only to the pseudonymised information provided by the protocol.

The CHMP also mentions that a guideline on “Electronic Systems and Electronic Data in Clinical Trials” is currently being developed. Once in force this guideline would constitute the definitive guidance on eSource EDC.