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Applications to incorporate projects onto the platform

What kind of studies can be presented to SCReN?

Multicentre clinical trials that are of scientific interest for both the National Health Service and the population in general, and in which more than one Clinical Research and Clinical Trial Unit (UICEC) participates.

Projects can be submitted at any stage of development.

When applicable, the relevance of including other types of projects that fit into the procedures and objectives of the platform will be assessed. These could include experimental studies about different interventions of medicinal products or medical devices and studies about medicinal products, different interventions of medicinal products or medical devices of alternative designs to that of the clinical trial, provided they are:

  • Research projects promoted by scientific societies or scientific groups.
  • Research projects evaluated positively in competitive Calls for funding with public funds.
  • Research projects that pose situations in which the experimental design is not feasible and there is a reasoned scientific uncertainty about the effectiveness and safety of medicinal products in the postauthorization period and under conditions of clinical practice.
  • Research projects that pose situations where there is a high probability of problems of use with the medicinal products, and these problems of use influence the effectiveness and safety of the medicinal products and have a high impact on the health system.

Who can present research projects?

If your centre has a Clinical Research and Clinical Trial Unit (UICEC) from the platform, please contact the person in charge of the unit. Together you can work on the application form for incorporating a project in SCReN.

If your centre is not linked to SCReN, please contact a person in charge of a Clinical Research and Clinical Trial Unit (UICEC) of Scren.

When can you present the project?

If the project is to be presented to a public Call for funding, you must submit the application which you have worked on with a Clinical Research and Clinical Trial Unit (UICEC) at least three weeks before the close of the Call.

If the project is not subject to a Call the application can be presented at any moment.

What documents do I need?

Together with the corresponding Clinical Research and Clinical Trial Unit (UICEC) you must complete:

  • Application Form of Projects to SCReN
  • Annex 1 (Only for projects requesting Pharmacovigilance)
  • Brief summary of the project, including:
    1. Background and justification (no more than 200 words)
    2. Hypothesis
    3. Principal and secondary objectives
    4. Evaluated strategy
    5. Principal and secondary variables
    6. Screening criteria of the study population (definition of the target population)
    7. Sample size expected and recruitment time planned
    8. Planned follow-up of the subjects (incorporating a time line)

Project evaluation process

Why are the projects evaluated?:

To check the scientific validity of the project

• To verify the feasibility

• And to review the platform's criteria for priority

Other frequent questions and answers

  • How to interpret the criterion?: "Reasonable project duration in accordance with the SCReN objectives"?

    Data to consider:

    • Initially, the execution time of the SCReN Platform ends on 31 December 2017
    • SCReN is evaluated annually
    • Trial duration is rarely less than 2 or 3 years.

    Based on these points:

    Projects with durations that exceed December 2017 will be accepted, however the commitments acquired will be reviewed to ensure:
        a) The economic conditions under which the project will be supported
        b) Any other structural change in the organization of the project

  • What is the best way to start the application process?

    Before the researchers apply for funding before the relevant agency, we recommend that they:

    • Contact the centre’s Clinical Research and Clinical Trial Unit (UICEC)
    • Calculate and draft the budgets and the proposal
    • Inform the MRP Assistant (ask the Clinical Research and Clinical Trial Unit (UICEC) for contact details)
  • When is the most effective moment to submit the application to SCReN?

    Once the project funding has been granted by the relevant agency. We believe that this procedure route simplifies the work of Clinical Research and Clinical Trial Units (UICECs), thereby reducing the administrative burden prior to the presentation to external Calls.

    Another useful way to expedite the process is by submitting the protocol together with the application documents, as it will shorten the evaluation process.

  • Can single-centre studies be presented to SCReN?

    The studies conducted in a Clinical Research and Clinical Trial Unit (UICEC), if they are ECRIN or EU-funded and are also conducted in other countries, will be undertaken by SCReN. Any other case would have to be clearly justified and will only be included as an exception.

  • Can studies that evaluate health products or medical devices be presented?

    Yes.

  • Can the project evaluators organize a teleconference to make a joint evaluation?

    Yes. This can be requested by contacting the Technical Secretariat.

  • When the project has been validated by the programs involved, what does the review by the evaluators provide?

    The evaluation carried out by the Evaluation Team is intended as a participatory activity involving the whole network of Clinical Research and Clinical Trial Units (UICECs) that form the platform, to provide different viewpoints with the aim of evaluating how the feasibility of the project fits in with prioritization criteria defined by SCReN.

  • What types of projects require a scientific evaluation by the Evaluation Team?

    A scientific evaluation by the Evaluation Team is required for projects that have not been presented to a competitive Call, that is, those that have not had a prior peer review.

  • Can I ask SCReN for 'collaboration-only' in a program?

    Single program activities can be requested in the case of the Monitoring and Regulation Program (MRP); any other request must also include MRP activities.