Work package 4


Leader: Prof. Jacques Demotes

Main objective

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 took 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 included:

Protocol assessment

ECRIN coordinated the assessment of the PRECIOUS protocol that described how the trial was conducted. This involved 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, checked the feasibility and practicality of the trial plan.

Monitoring training

To ensure that the protocol and all the necessary regulations were followed correctly monitoring of the clinical trial was an important part of the project. Before PRECIOUS started, monitoring training was given to all relevant persons involved in the trial such as the monitors, investigators and collaborators. The training described the monitoring visits to the sites where the trial was conducted to ensure quality of data. The training was the same in all countries to ensure homogeneity and similar quality standards.

Performing and coordinating monitoring

Once the trial was running, regular monitoring visits were made to the sites. A monitoring report was written at the end of each monitoring visit. The visits verified that the patients were properly informed about the trial, the inclusion and exclusion criteria were respected, the correct results were being recorded, and there were no unexpected negative effects of the treatment. A central manager coordinated all these monitoring activities and sent the reports to UMC.

The combination of protocol verification at the start of the trial, harmonised cross-country monitoring training, and continuous monitoring in all countries and sites aimed to promote reliable quality results.

PRECIOUS: List of Work Packages

WP 1: Trial Management

WP 2: Outcome Adjudication

WP 3: Infections and Antimicrobial Resistance

WP 4: Monitoring

WP 5: Health Economics

WP 6: Safety Monitoring

WP 7: Statistical Analysis

WP 8: Dissemination, Exploitation and Communication

WP 9: Project Management