Defining roles and responsibilities across stakeholders

ERDERA launches online training on managing multinational clinical trials for rare diseases

Training online

ERDERA launches a new, beginner‑level online course today —Management of multinational clinical trials for rare diseases—to help Europe’s clinical research community run better, faster and more inclusive studies for people living with a rare condition.

Designed around the needs of trials in rare diseases, the training tackles real‑world bottlenecks that slow multinational trials and can limit patient access, strengthening trial readiness across Europe.

Anchored in ERDERA’s Training and Education Workstream—and closely linked with our Clinical Research Network and the alliance’s hubs for expertise, data and acceleration—the course is led by ECRIN.

“This course will bring learners to reflect on the steps in the development and planning of rare disease trials. Built on over 20 years of expertise from ECRIN and its national partners in the conduct of multinational trials, the focus is on ensuring that trial teams can identify and troubleshoot the existing bottlenecks”, says Marta del Álamo, Head of Capacity Projects at ECRIN.

What the course covers

This three‑hour programme familiarises investigators and site teams with the specific challenges of initiating and managing multinational rare‑disease trials. It is solution‑oriented, addressing common barriers such as differing national implementations of European clinical research Regulations and ethical requirements.

Participants learn to define roles and responsibilities across stakeholders to ensure good study management and harmonisation between countries. Funding sources and the essentials of budget preparation for multinational settings are also covered.

Learners are provided access to the materials for two weeks and receive proof of completion.

Who should join and how

The course is tailored for principal investigators, sub‑investigators, study coordinators and project managers who need training on the management of multinational rare‑disease trials. It is free of charge, delivered in English, and open as of today—16 September 2025—by registration, with a limited number of licences available on a first‑come, first‑served basis.

By building practical skills where they are most needed, this training advances ERDERA’s pillars of patient involvement, cross‑disciplinary collaboration, and education and capacity building—while supporting international alignment across systems. ERDERA encourages interested teams across Europe to register and share within their networks.

Click here to access the training.

For additional details, visit the ERDERA website, and learn more about the lead organisation, ECRIN.

News & Updates

You might also be interested in

ERDERA’s ethics and regulatory experts are launching a dedicated webinar series to help the rare disease research community navigate two fast-moving areas of biomedical research: Advanced Therapy Medicinal Products (ATMPs) and Artificial Intelligence.
July 24 @ 3:00 pm - 4:00 pm
This webinar will present a theoretical framework for situating ethics across research activities. The framework will then be brought to life through a relevant case study discussion, giving participants a concrete reference point for the episodes ahead.
ERDERA (the European Rare Diseases Research Alliance) has opened its Clinical Trial Call to support multinational early-phase clinical trials in rare diseases. The call will fund studies designed to generate robust clinical evidence, strengthen regulatory readiness and make rare disease trials more feasible across countries.
Call text draft setting out rules, eligibility and staged application process for the ERDERA Clinical Trial Call 2026.