Prof. Truls Myrmel and his team from the University Hospital of North-Norway have received the green light to start recruiting their first patients. This important step for the EURO SHOCK clinical trial on CGS comes after months of intense work. Other institutions will start recruiting in the coming weeks.
The process to approve a recruiting site is led by the clinical trial sponsor, who takes responsibility to initiate, and manage or finance the clinical trial, but does not conduct it. This role in EURO SHOCK is performed by the University of Leicester.
The EURO SHOCK consortium put months of intense work into the preparation of the trial. Common documentation, including consent forms and patient information material, are jointly developed by EURO SHOCK’s ten clinical centres and the sponsor. Each site also has to undergo their country-specific ethical process, which required the translation of the documentation into local languages. The last step in preparation for the trial is the Site Initiation Visit (SIV) to monitor and ensure the site is ready to recruit patients.
Clinical trials: Sponsors and sponsor-investigators. Retrieved on 24.09.2019 from https://learn.marsdd.com/article/clinical-trials-sponsors-and-sponsor-investigators/
Site Initiation Visit (SIV). Retrieved on 24.09.2019 from https://www.nbt.nhs.uk/research-innovation/running-your-study/site-initiation-visit-siv