During 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

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ACT-EU is the stakeholder fora and groups within the European medicines regulatory network (EMRN) 

Published by ACT EU

Clinical TrialCTAGNetworkRegulatory

A list of stakeholder fora and groups within the European medicines regulatory network that are involved in the clinical trial lifecycle. Detailed information is published on each group or forum, along with a visual representation of their interactions.

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Patient Engagement Resource Center

Published by EATRIS

Patient EngagementPatient InformationResearch and Drug Development

The Patient Engagement Resource center is an easy to navigate platform to help researchers get started with patient engagement in research. This toolbox provides helpful resources to help researchers understand the basics of patient engagement, and guide them through the different phases of patient engagement, from planning to conducting and evaluating.

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Short guide on patient partnerships in rare disease research projects

Published by EJPRD

Patient EngagementPatient InformationResearch and Drug Development

This guide has been developed with the help of a working group comprising of patient representatives and research funders. Its main goal is to encourage fruitful, sustainable and enduring partnerships between scientists and patient organisa tions, co-leading the way for systematic patient-centered research. It also aims to foster a partnership culture and contribute to an improved understanding of the added value of patient engagement and involvement in basic, pre-clinical, translational and social research for the Rare Disease Community in Europe and beyond.

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Clinical trials – Regulation EU No 536/2014

Published by EMA

Clinical TrialRegulation

The Regulation will ensure a greater level of harmonisation of the rules for conducting clinical trials throughout the EU. It introduces an authorisation procedure based on a single submission via a single EU portal, an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, and transparency requirements

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The European Medicines Agency publishes scientific guidelines on human medicines that are harmonised by the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

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Rare Diseases Clinical Research Network (RDCRN)

Published by NCATS

Clinical DevelopmentNCATSNetworkRDCRN

The RDCRN program is designed to advance medical research on rare diseases by providing support for clinical studies and facilitating collaboration, study enrollment and data sharing. Through the RDCRN consortia, physician scientists and their multidisciplinary teams work together with patient advocacy groups to study more than 200 rare diseases at sites across the nation.

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Rare Diseases Registry Program (RaDaR)

Published by NCATS

Patient Registry

RaDaR, formerly known as the Global Rare Diseases Registry Data Repository program, aims to define best practices for patient registries. RaDaR also strives to identify and adopt standards to support high-quality registries for rare diseases therapeutics development.

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