Work package 4: Monitoring
Leader: Audrey Strader, ECRIN
To provide international monitoring services and the coordination thereof for the conduct of PRECIOUS, according to ICH-GCP guidelines and relevant national and international regulations.
Description of the tasks
Assessing the clinical trial protocol and overseeing the conduct of the trial
In this work package, ECRIN takes care of protocol assessment and monitoring. ECRIN’s expertise lies in coordinating trial activities across multiple countries, which is where many challenges are faced in multinational projects such as PRECIOUS.
Work package 4 includes:
ECRIN will firstly coordinate assessment of the PRECIOUS protocol, which is the document that describes how the trial will be carried out. This involves assessment of the study design by the ECRIN Scientific Board and external referees to ensure scientific excellence. In parallel, a logistical assessment, carried out by ECRIN’s European Correspondents based in different countries, checks the feasibility and practicality of the trial plan.
Monitoring is overseeing the trial while it is running and checking to ensure that the protocol and all the necessary regulations are being followed correctly. Before PRECIOUS starts, monitoring training will be given to all the relevant people involved in the trial such as the monitors, investigators and collaborators. The training describes the monitoring visits to the sites where the trial is taking place and the checks that should be made to ensure that the data from the trial are of very high quality. The training is the same in all countries so that the activities will be performed consistently at all the trial sites.
Performing and coordinating monitoring
Once the trial is running, regular monitoring visits will be made to the sites and reports written. The visits verify that the patients are properly informed about the trial, the inclusion and exclusion criteria are respected, the correct results are being recorded, and there are no unexpected negative effects of the treatment. A central manager coordinates all these monitoring activities and sends the reports to the UMCU.
The combination of protocol verification at the start of the trial, harmonised cross-country monitoring training, and continuous monitoring in all countries and sites aims to promote reliable quality results.