WP6 is responsible for the operational management of the CVS. Partner ECRIN will work closely with the Sponsor and the lead CTU (both UKSH), the clinical leads, the CKI-TF, the technology partners, WP8 (especially around the topic of informed consent) and WP9 (especially around the issues with alignment with legal and data protection, and regulatory requirements). ECRIN will inform on the conditions for regulatory, ethical and data protection authorization, as well as the insurance / indemnification requirements (taking into account the changes in the clinical study and the medical device regulations), according to the final design and protocol of the CVS, the regulatory status of the study in the Sponsor country (Germany) and the other participating countries (i.e. Austria, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Spain, UK). ECRIN, in collaboration with the Sponsor, will define a monitoring plan in line with appropriate regulations, and prepare all the study documentation pack for the relevant national submissions to ethics and regulators as necessary. This includes all necessary translations of patient facing documents, such as participant information sheets (PIS) and Informed Consent Form (ICF). We will ensure that (i) all national required authorizations are obtained and in place before recruitment starts, (ii) a Sponsor-ECRIN task delegation agreement is signed, (iii) a site initiation is conducted and (iv) routine scheduled study monitoring as per the monitoring plan is performed. ECRIN will conduct the operational management and ensure oversight of the CVS, including local monitoring and support adverse event reporting by local sites, on the national level in the participating countries, linking this to the central coordination by the Sponsor.
Objectives
Planning and operational management of the multi-national, multi-centre clinical validation study
O6.1 Ensure regulatory compliance of the Clinical Validation Study (CVS) in participating countries.
O6.2 Ensure effective operational management for the CVS across all participating countries.
O6.3 Provide support and services for the management of the CVS, according to ICH-GCP guidelines and national and international regulations.
Deliverables
D6.1 First version of the clinical validation study protocol
D6.2 Finalised master documents in English for ethical/regulatory submissions, including study protocol & PIS/ICF for clinical validation study
D6.3 Final version of the Monitoring Plan for the clinical validation study
D6.4 First study subject approvals package of the CVS
D6.5 Midterm recruitment report of the CVS D6.6: ‘Report on status of posting results’ of the CVS
