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.
The GCP certificate can be obtained through the e-learning courses listed below. EC Research currently also accepts certificates obtained after attending an online training course approved by Transcelerate.
For UZ Leuven (and KU Leuven staff):
- Leercentrum: ICH-GCP R3 - Good Clinical Practices
KU Leuven staff must first create an account with the UZ Leuven Learning Centre. This can be done via: https://www.uzleuven.be/leercentrum. Navigate to the ‘External users’ section and follow the instructions for creating an account.
Generally available eLearning: