In June 2013 representatives of the eClinical Forum participated in a meeting with the EMA GCP Inspectors working group (IWG) to discuss specific concerns, interpretation of requirements and possible solutions relating to data transcribed to electronic data collection tools in clinical trials and the requirement for investigators to keep a contemporaneous and independent copy of the eCRF. Key messages covered: a) The existence of a contemporaneous, independent copy of the eCRF under the exclusive control of the investigator is a requirement irrespective of the media used, b) The eCRF has to be considered as source even when data is transcribed from source records, c) Some of today’s EDC solutions may not completely address the regulatory requirements and the industry should move to compliance.
The eClinical Forum has now set up a task force to establish guidance and clarification as to how a trusted third party hosted web-based EDC system can provide a regulatory compliant solution. The scope of the project includes technical aspects of the solution, contractual arrangements and clarification of the tasks and responsibilities of the sponsor, investigators, the third party hosting provider and CROs. The EMA regulatory requirements for investigator control of transcribed data are the same as for electronic source data and those in turn are equivalent to FDA electronic source guidance, so the work of the task force has broad application and relevance. The group has now met with several regulators over a period of several years, with the outcome of these meetings provided in meeting notes provided to eCF members and a publically published white paper.