Target Health Blog

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

April 8, 2019

What's New

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 are 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 changing 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.

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

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