We request a dated and signed short CV of the principal investigator of the study. The CV should contain the necessary information for the EC to assess the suitability/competence of the principal investigator (education, current position, professional experience, relevant experience in clinical trials, etc.). For the CV we refer to the Transcelerate template.
The CV should also specify a Good Clinical Practice (GCP) certificate, including the date of obtaining the certificate (maximum 3 years old) and the organisation where the certificate was obtained. The GCP certificate may also be submitted as a separate document. GCP training is required for each principal investigator.
EC Research asks to attend the full GCP training organised by the Biomedical Sciences Group KU Leuven at least once. Moreover, it is possible to only take the exam without having to follow the full-day training again. EC Research currently also accepts certificates obtained after attending an online training course approved by Transcelerate.