Clinical Trial Site Capacity Building

Work package objectives:

WP5 aims to provide an infrastructure capable of rapidly implementing randomized controlled trials (RTCs) related to vaccine efficacy, safety and tolerability. The Site Network is VACCLERATE’s tool to enable Europe-wide mapping of clinical trial sites capable of conducting phase 2 & 3 COVID-19 vaccine trials. Therefore, the team evaluates current clinical study capacities, develops a mechanism for site selection and conducts site assessment based on past performance. WP5 defines minimum good quality standards and key performance indicators, and aims for harmonisation to international GCP standards by delivering educational courses for site personnel and developing Study Nurse courses.

WP Lead:

Dr. Patricia Bruijning-Verhagen

Associate Professor Infectious Diseases Epidemiology,                                            Julius Centre for Health Sciences and Primary Care, Department of Infectious Diseases Epidemiology                                                                                                      University Medical Centre Utrecht 

Work Package Results

All public documents can be shared upon request. Please contact: info@vaccelerate.eu.

Good Clinical Practice (GCP) Course

This online Good Clinical Practice (GCP) course is provided through the European Centre for Clinical Research Training (ECCRT) and is available on the ECCRT virtual campus. The training enables participants to understand the responsibilities of everyone involved in clinical research. It teaches the conduct, performance, monitoring and reporting of a clinical trial using interactive quizzes and exercises for self-assessment.

More information: https://vaccelerate.eu/academy-2/

Study Nurse Course

This course is designed for study nurses and will provide the needed expertise to conduct a clinical trial. Study nurses are responsible for organizational processes and they are the central link between physicians, patients, sponsors, clinical research organizations, and ethics committees. The course is based on the curriculum of the KKS Network, a German association of academic coordinating centers for clinical studies, and uses the standards set out in ICH GCP E6 (R2).                              Next to the regulatory background the course also tackles and trains practical aspects necessary for the work as study nurse.

More information: https://vaccelerate.eu/academy-2/