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eSource Direct Data Capture – (EMA/282576/2018)

April 6, 2019




On 18 October 2018, EMA issued an eSource Direct Data Capture (DDC) Qualification Opinion. This Qualification Opinion is intended to give information about the regulatory acceptability for the use of an eSource Direct Data Capture system (DDC, or simply eSource in the EMA document) in clinical trials conducted to support a “Marketing Authorisation Application” for a medicine in Europe.

As a company, we have been doing web-based DDC for 10 years with regulatory approvals. In our system, the eSource record is placed into a trusted 3rd party hosted environment, before the data enter the clinical trial database. Access to these eSource data is controlled by the clinical investigator.

There many points made in the EMA opinion that are very important when DDC is utilized; and clarify the value, as well as legitimate concerns for all clinical trial stakeholders. The only concern that we have is to differentiate the requirement for data to be contemporaneously located in an EMR or EMR, which tend to be commercial software packages. We suggest to change the wording to say that collected clinical trial data should be available in “real time” in a compliant Medical Record, and that the Medical Record must be in human readable format and under control of the clinical trial Investigator. In this way, different solutions can be compliant to common medical and regulatory requirements.

Originally published on April 6, 2019 on LinkedIn:

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