PRISM opens its Transnational Access call (TNA1) for paediatric multinational investigator-initiated clinical studies.
Academic and non-commercial sponsors can submit a Letter of Intent until 31 December 2026, 17:00 CET, for access to coordinated, end-to-end trial management services for multinational paediatric studies in Europe and Canada.
The PRISM consortium has opened its first Transnational Access call (TNA1). Funded by the European Union's Horizon Europe programme under Grant Agreement No 101292607, the call will select paediatric multinational investigator-initiated clinical studies and provide them with coordinated, end-to-end trial management services, from study start-up to the final close-out visit.
Paediatric investigator-initiated clinical studies address pressing public health needs, but face significant operational and regulatory hurdles when expanding across borders. PRISM addresses this capacity gap by combining the infrastructure services and operational expertise of its partners, to support the feasibility, regulatory compliance and recruitment targets of selected studies.
Who can apply?
- Investigator-initiated clinical studies with a single non-commercial, experienced sponsor located in Europe (European Union, Norway, Switzerland, United Kingdom) or Canada, with a sponsor representative where required.
- Studies recruiting in 3 to 6 countries across Europe and Canada, with a maximum of 15 sites (except cluster randomised controlled trials).
- Study populations from birth to 18 years old: preterm and term neonates, infants, children and adolescents. Maternal-infant studies are eligible if the intervention targets the infant.
- A maximum study duration of 30 months, from study start-up to the close-out visit.
Which studies are eligible?
- Pragmatic, investigator-initiated randomised controlled trials comparing or optimising healthcare strategies, with therapeutic (with or without health products), diagnostic or preventive interventions.
- Prospective observational cohort studies.
- Studies may address any paediatric disease area except oncology and rare diseases. Commercial, industry-sponsored studies, basic, pre-clinical and phase I research, and studies already running are out of scope. The full list of exclusions is provided in the call text.
What do selected studies receive?
Applicants may request a budget of EUR 1.0–2.0 million for interventional studies, or up to EUR 1.0 million for observational studies. The budget covers investigational costs allocated to recruiting sites, project management costs of the sponsor, and the cost of the PRISM service package.
The ECRIN Coordinated Service Package is mandatory. It covers study management and coordination, regulatory and ethical approvals, monitoring, vigilance, data management and data sharing. Applicants are also expected to select at least one additional PRISM service: international collaboration with Canada (MICYRN), epidemiological/statistical analysis (SCTO/USBL), decentralised elements in paediatric trials (ENoLL), digital patient-reported outcome measures (iSPRINT), or a GenAI-enhanced eCRF (AINIGMA).
How to apply
The call follows a two-stage procedure:
- Stage 1 – Letter of Intent: submit a template-based PDF and complete an online questionnaire on the PRISM call submission platform by 31 December 2026, 17:00 CET (11:00 EST).
- Shortlisted applicants will be notified by 22 February 2027 and will receive dedicated support from the PRISM infrastructure to refine their protocol and project proposal.
- Stage 2 – Full proposal: submission by 30 June 2027, followed by an evaluation and an interview with an independent jury in July and August 2027. Selected projects will be announced on 1 September 2027.
- Proposals are evaluated by independent expert reviewers against the three Horizon Europe criteria: Excellence, Impact, and Quality and efficiency of the implementation.
PRISM TNA1 Call Launch webinar – 8 October 2026
An information webinar will present the call requirements, the PRISM service package, and provide an opportunity for participants to ask questions about the call on 8 October 2026, 16:00 CEST (10:00 EDT), on Zoom.
Find out more
Questions: PRISM Joint Call Secretariat – call2026@prismeu.org
Full call text Submission platform