EMA-raadpleging: ontwerp-kwalificatieoordeel over eSource Direct Data Capture (DDC)
The European Medicines Agency has released for public consultation a draft qualification opinion on eSource Direct Data Capture (DDC).
This Qualification Opinion is intended to give information about the regulatory acceptability to use an eSource Direct Data Capture (DDC, or simply eSource in this document) 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 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. 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. It should also be noted that guidance on Electronic Systems is currently under development at EMA, and once into force it would constitute the definitive guidance.
We would be particularly interested to hear about any experience or perceived impact that this type of systems may have on the conduct of clinical research and on patient care.
The draft qualification opinion is available by clicking here.
Comments should be provided using this template and sent to Qualification@ema.europa.eu by 14 March 2019.
Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.
For more information on the European regulatory system for medicines, please consult our brochure.