How ECRIN supports multinational extension of clinical trials
Projects evaluated positively within the scope of this call gain access to services for their implementation in countries other than the sponsor’s. Services will be provided by the national ECRIN partner institutions. Their cost is covered by the ECRIN Integrating Activities project.
• interaction with ethics committees and competent authorities (submission and follow-up);
• translation/back-translation of relevant documents and adaptation of protocol and informed consent;
• local training of study personnel;
• local monitoring (including on-site);
• local support for reporting adverse events;
• local management of investigational medicinal products and blood and tissue samples.
Which projects are eligible
• Investigator-initiated, multinational, randomized clinical trials;
• with secured public or charity funding for conduction of the trial in the sponsor’s country;
• targeting rare diseases, medical devices, nutrition.
Which institutions can apply
Public or private no-profit institutions.
Partnership with for-profit entities is allowed provided that the data ownership and analysis are independent from the commercial partners.
Evaluation is done by the ECRIN Scientific Board with the support of external reviewers and is based on:
1. possible impact on the health of European citizens;
2. scientific merit and excellence;
The candidate trials must comply with the ECRIN acceptance criteria.
How to submit your project
This call follows a two-step procedure. In the first step applicants are required to provide a brief letter of intent. For studies admitted to the second step applicants are required to provide a full study protocol.
A Notice to Applicants and Online Submission Portal will be available soon.
For further information, please see: http://www.ecrin.org/index.php?id=417
or refer to your national ECRIN European Correspondent: http://www.ecrin.org/index.php?id=107