The EU GCP Inspectors Working Group (EU GCP IWG) is currently working on a new Data Integrity guidance which is expected to be published in draft form soon. The work on the EU GCP Guideline on Electronic Systems and Electronic Data in Clinical Trials has been announced in the Work plan for GCP Inspectors Working Group for 2018.
Ib Alstrup, GxP/ IT Medicines Inspector at the Danish Medicines Agency, will provide some insights about "Data Integrity - Expectations and Findings" at ECA´s upcoming DICT - Conference. Find out more about electronic systems and electronic data in clinical trials at D.I.C.T. - Data Integrity in Clinical Trials from 17-18 September 2019 in Copenhagen, Denmark.