Questions & answers

Most asked

Do sites need to be defined at the Letter of Intent stage?

Sites must at least be identified at the Letter of Intent stage.

Can PRISM fund a randomised controlled trial that has already started as a pilot study?

No. A randomised controlled trial that has already started as a pilot study is not eligible for support under this call. The same applies to a pilot study already running at one or two sites whose proposal expands its objectives and scales up to a larger number of sites: it remains ineligible. Applicants should therefore submit studies that have not yet started.

What is considered an eligible site?

Sites recruiting participants. These can be hospitals as well.

Does the 30-month duration include study start-up?

The maximum study duration is 2.5 years (30 months), covering all phases from study start-up to completion of the close-out visit.

Who submits the application?

Only one submission is made per project, by the main Principal Investigator, on behalf of the whole consortium.

Eligible study types and design

Are medical device studies eligible?

Yes, medical device studies are eligible.

Ongoing and pilot studies

Can PRISM fund a randomised controlled trial that has already started as a pilot study?

No. A randomised controlled trial that has already started as a pilot study is not eligible for support under this call. The same applies to a pilot study already running at one or two sites whose proposal expands its objectives and scales up to a larger number of sites: it remains ineligible. Applicants should therefore submit studies that have not yet started.

Is a pilot study already running at one or two sites eligible if the proposal expands its objectives and scales up to 15 sites?

No, it is not eligible.

Disease scope

How is a rare disease defined?

For this call, rare diseases are those with a prevalence lower than 5 per 10,000 people.

Sponsor, applicant and consortium

Who submits the application?

Only one submission is made per project, by the main Principal Investigator, on behalf of the whole consortium.

Is there a PRISM partner-finder tool?

No.

Sites and countries

Do sites need to be defined at the Letter of Intent stage?

Sites must at least be identified at the Letter of Intent stage.

What is considered an eligible site?

Sites recruiting participants. These can be hospitals as well.

Is a minimum of three countries required?

Yes. Studies recruit in 3 to 6 countries.

Are the mandatory service packages limited to ECRIN countries?

No. The service packages are not limited to ECRIN countries: TNA services are open to all eligible countries.

Budget and costs

When are the payment milestones expected?

This information will be provided in the Stage II guidelines.

More information on financial aspects (budget, indirect costs, cost of the service packages) will be provided in a follow-up Q&A in the coming days.

Timeline, selection and process

Does the 30-month duration include study start-up?

The maximum study duration is 2.5 years (30 months), covering all phases from study start-up to completion of the close-out visit.

How many projects will PRISM fund?

PRISM expects to fund 2 to 3 projects.

Who can I contact while preparing my Letter of Intent?

The PRISM Joint Call Secretariat: call2026@prismeu.org. The full call text and the application platform are available on the Calls page.

Patient and public involvement

Is patient and public involvement expected in the design of the study?

Patient and participant engagement is recommended.