Services do NOT include
The submission in sponsor country and clinical trial conduct services (after the authorisations) are not included in this TNA.
Submission and follow-up with the regulatory authorities and ethics committees.
Sample Requirements - input of users
The user/sponsor of the trial will have to provide the master study documents necessary for the submission (e.g. Protocol, Informed consent, financial contracts, etc).
Description of service
ECRIN will provide consultancy and TNA services for human vaccines clinical trials development. In particular ECRIN will provide all the necessary information regarding the regulatory and ethical requirements necessary for a specific clinical trial (Scheme 1).
ECRIN will provide access to methodological experts for advice and the review of the clinical protocols. Consultancy will also be offered for the development of funding applications and especially for all aspects regarding the organisation of the management and logistical aspects of multinational clinical trials. ECRIN provide actual services, through its national scientific partners, encompassing the management of the clinical trials and in particular the regulatory and ethical submissions in multiple countries as TNA service.
Scheme 1 – Global Clinical Trial Process. In TRANVAC II, ECRIN will provide consultancy support to the:
Clinical trial Methodology;
Planning of clinical trial operations;
Preparation of a proposal for funding, specifically in what regards clinical trial operations;
Preparation of study documents; These services do not include actual preparation of documents – only consultancy advice.
ECRIN will submit the clinical trial dossier to the several Competent authorities and Ethical Committees in different countries involved in the trial;
This service will be provided for free. Services related to the set-up towards the completion of the trial (initiation, management, monitoring and close-out) are out of the scope of this call, but upon funding/payment ECRIN can provide these services