ECRIN's Quality Manager attended the GCP IWG joint meeting with interested parties on topics related to e-source data / electronic data capture (EDC) tools in clinical trials, held on 12 June 2017 at the European Medicines Agency (EMA).
The aim of the meeting was to provide an opportunity to discuss 'hot topics' in clinical trials between the EMA GCP IWG and interested parties represented by EuropaBio, eclinical Forum, EUCROF, EFPIA, SCDM, Transcelerate, and ECRIN. Sessions included:
- Inspection findings related to e-systems & their vendors
- Risk-based software validation
- Requirements for a good audit trail
- Electronic informed consent