MoH approved Clinical Trial Agreement template in CZ and SK

We would like to inform you that, on 3rd May 2019, the Ministry of Health of the Czech Republic published on its website a Methodological Guideline on the Content of a Clinical Trial Agreement of a clinical trial of medicinal products for human use dated 30th April 2019, which includes a template Clinical Trial Agreement. The Ministry requested all clinical trial sponsors and healthcare providers involved in clinical trials to use such a template agreement as much as possible. The guideline is applicable to all Ministry-directly-managed hospitals (all of the major ones).

The template agreement is designed as a 3-party agreement between a sponsor, a site and an investigator. The agreement is bilingual (Czech and English) and reflects relevant EU and Czech legislation as well as key GDPR aspects.

The main objective of this template agreement is to shorten and simplify the process of executing a clinical trial agreement between sponsors and healthcare providers. The use of a template agreement should also lead an increase in the number of clinical trials performed in the Czech Republic and to the improvement of the Czech Republic’s position in international competition in clinical research. The Ministry’s ideal is that if the agreement will not be amended, it should be automatically accepted by the Ministry directly-managed hospitals.

The Methodological Recommendation in question is available on the website of the Ministry of Health of the Czech Republic, in the section “Legislation” and in the subsection “Clinical trial” (http://www.mzcr.cz/Legislativa/obsah/klinicke-hodnoceni_4016_11.html).

The Ministry of Health of the Slovak Republic approved a similar template Clinical Trial Agreement. The template agreement is a part of the Order of the Minister of Health No. 4/2018 and it is available on the website of the Ministry of Health of the Slovak Republic which is available on the website of the Slovak Ministry of Health (https://www.health.gov.sk/Clanok?Prikaz-4-2018). The Order of the Minister, with respect to the template agreement, is effective from 1st June 2019.

Our office was involved in the preparation of both of the agreements in the Czech Republic and Slovakia.

Please do not hesitate to contact us in case of any questions via our email (info@kastnerpies.cz).