Work package 1: Trial Management
Leader: Dr. Bart van der Worp, University Medical Center Utrecht
Ensure the successful startup, execution and completion of the clinical trial.
This can be split into several objectives:
- Design, planning and coordination 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 80 sites in 9 European countries;
- Ensure that 3800 patients with acute stroke are participating in the trial;
- Write a study report at the end of the trial
Description of the tasks
The central study team of the clinical trial is located at the UMCU and this team will ensure a successful start-up, execution and completion of the trial. In collaboration with other study partners, the UMCU has been responsible for most of the design and planning of the trial. An important part of the preparation consists 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.
Also, the UMCU has built a web-based randomisation system for the trial. By means of this system, physicians can allocate patients to one of the treatment groups. A secured data system will be used to register all relevant medical data of the patients who participate in the trial. During the course of the trial, the UMCU will oversee the execution of the trial in each of the 80 participating hospitals in all 9 countries on a day-to-day basis. This means that the UMCU will train and support the staff in other hospitals together with the national coordinators and the UMCU will help to resolve any issue that occurs during the project.
The UMCU will also check that enough patients are participating in the trial and that the total of 3800 patients will be reached at the end of the study period. The study team at the UMCU will also be the central contact point for other partners of the trial, such as the safety monitoring team. At the end of the trial, the UMCU will write a study report, which will be published in an international scientific journal to inform other physicians about the results of the trial.