The European Medicines Agency (EMA) has released for public consultation a draft Qualification Opinion concerning the use of eSource Direct Data Capture (DDC) in the conduct of clinical trials in the EU. The document is intended to give information about the regulatory acceptability to use an eSource Direct Data Capture in clinical trials conducted to support a Marketing Authorisation Application for a medicine.

In the context of this Qualification Opinion, the general term “eSource DDC” refers to an electronic application and/or device that allows direct entry of source data, and it directly identifies 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. It is not intended to identify or support a specific proprietary system, but to discuss some of the characteristics a system for direct data entry should present.

The potential advantage of eSource DDC is that it eliminates the need to capture clinical trial source data on paper or electronic media. Therefore, the clinical trial data gathered would automatically be transcribed in eCRFs. The draft Opinion explains that direct data entry in the eSource DDC would permit immediate checks of the completeness of the data entered, thus avoiding erroneous or incomplete data entries.

The draft qualification opinion is available by clicking here.

Comments should be provided using the specific template and sent to [email protected] by 14 March 2019.