Work package 1

Trial Management

Leader: Prof. Bart van der Worp
University Medical Center Utrecht (UMC)

Main objectives

Ensure the successful implementation and completion of the clinical trial.

Design, plan and coordinate the clinical trial

Build and maintain a secured online web-system, which can be used to register medical records

Obtain approval from the government for the trial at maximum 100 sites in 9 European countries

Ensure that at least 2500 patients with acute stroke are participating in the trial

Write a study report at the end of the trial

Description of tasks

The central study team of the clinical trial was located at the University Medical Center Utrecht (UMC). The team ensured a successful start-up, execution and completion of the trial. In collaboration with other study partners, UMC was responsible for most of the design and planning of the trial. An important part of the preparation consisted of getting approval from national and institutional review boards and taking care of all the regulatory requirements to perform the trial in each participating country.

UMC built a web-based randomisation system for the trial. By means of this system, physicians allocated patients to one of the treatment groups. A secured data system was used to register all relevant medical data of the patients who participated in the trial. During the course of the project, UMC oversaw the execution of the trial in each of the 82 participating hospitals in all 9 countries on a day-to-day basis. UMC trained and supported the staff in other hospitals together with the national coordinators.

UMC checked that enough patients were participating in the trial. The study team at UMC was the central contact point for other partners of the trial, such as the safety monitoring team. At the end of the trial, UMC wrote a study report, which will be published in an international scientific journal.

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