When planning a multinational clinical trial, you need to consider financial, scientific, regulatory and administrative aspects long before you recruit the first patient. It is necessary to access experts and patients at other sites and countries, but complying with local regulations and requirements, sourcing services, and identifying collaborators can be a challenge. ECRIN is here to guide investigators/sponsors, project coordinators and other stakeholders through the different facets of multinational trial organisation.
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ECRIN’s Data Centre Certification programme is ISO 9001:2015 certified and was developed to audit European, non-commercial data centres using ECRIN IT/DM standards, to confirm their ability to provide compliant, effective, and efficient data management services for controlled clinical trials
View this resource Bookmark this resourceDuring project implementation, ECRIN offers investigators and project coordinators various trial management services, accompanying them all the way from recruitment of the first patient to scientific publication. ECRIN services include:
Submissions to competent authorities & ethics committees: ECRIN can manage submissions to regulatory and ethics authorities in participating countries, ensuring that timelines are respected to avoid delays
Insurance support: ECRIN can provide information regarding multinational trial insurance OR ECRIN can provide quotations for local insurance for multinational clinical trials
Monitoring: All tasks related to monitoring such as training, on-site visits and reporting can be handled by ECRIN across country sites
Adverse event reporting: ECRIN can support local reporting according to national requirements
Data management: ECRIN-Certified Data Centres may be used for data management in multinational trials (learn more about Data Centre Certification)
Recommendations for health product and biosample management: ECRIN can provide contacts for medicine and sample handling across countries
ECRIN Clinical research metadata repository
Published by ECRIN
Clinical Research metadata repositoryECRINThe Clinical Research Metadata Repository is the online tool to help scientific researchers find documents and data linked to a clinical research study, and to obtain information on the accessibility of those results. ECRIN made the Clinical Research Metadata Repository freely available for all scientific researchers, and is updated regularly through collection of data from the most important sources of information worldwide, from New Zealand to The Netherlands and from Japan to Lebanon.
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