Research environment grant within clinical therapy research

You apply electronically in Prisma External link, opens in new window., which is the application system used by the Swedish Research Council. You create your application in Prisma by filling in the text fields, uploading information from your personal account, and attaching the appendices requested.

To enable you to apply, your organisation must have been approved as an administrating organisation Opens in new window. and have created an organisation account in Prisma.

For most items in Prisma, there is a user manual External link, opens in new window. describing all the steps, as well as answers to FAQ External link, opens in new window.. Please refer to these when filling in your application.

Please avoid stating your own or anybody else’s full personal identity number in the application except where specifically requested.

Creating a personal account in Prisma

Before you apply, you must create a personal account in Prisma External link, opens in new window., where you can save your personal and CV data. The information only needs to be entered once, and can thereafter be supplemented or changed as required. As the Swedish Research Council uses foreign reviewers for this call, please use English when entering any descriptive text in your CV data. You can also input your publications for future use. Please note that no publications can currently be uploaded from your account to the application form. This is because the publications function is under development and not yet used in the Swedish Research Council’s calls. You should therefore submit your publications list as an attached PDF file instead (please see instructions under “Publications” below).

Please allow plenty of time to create your personal account. The applications you register in Prisma will be linked to your personal account.

All other persons participating in your application must also create a personal account in Prisma and confirm their participation. Thereafter they can add their data to the application via their personal accounts

Text

Some text fields can be formatted, which means that the font, alignment and font size can be changed, and that tables and symbols can be inserted. If you insert text written using a word processing program (such as Microsoft Word), you may need to use the tools in Prisma to adjust the formatting after insertion. Images cannot be included in the text fields, however. We recommend that you use the fonts Arial, Calibri or Verdana.

All text fields have a limit on the number of characters, and this is illustrated by a character counter. If you use too many characters, the application cannot be registered.

Attached documents and appendices

You will need to attach an appendix to some fields as instructed. The appendix must consist of one file only, and you can only attach documents in PDF format. All appendices are limited as to file size and number of pages. You will not be able to register your application with an appendix that exceeds the stated maximum size.

Signing

Both you as applicant and an authorised representative of the administrating organisation shall sign the application electronically in Prisma. Please see further information under “Registering the application” below

Please refer to the application form in Prisma in parallel with reading the instructions below.

Language

Foreign experts are involved in the scientific evaluation of the applications. To ensure fair and equitable assessment and efficient processing, please therefore complete your application in English.

Sections of the application

The application form includes the following tabs:

• Descriptive data
• Research description
• Call-specific information
• Budget and research resources
• Publications
• Administrating organisation
• Review panels
• Participants
• Cv

Descriptions of the information requested under each tab follow below. Mandatory information is marked with an asterisk (*) in Prisma.

Descriptive data

Under this tab, please fill in the Swedish and English project title, and select SCB codes and key words. Please also fill in the abstract and popular science description as instructed below.

Abstract

The abstract shall include a brief description of:

• what is to be done: what and why
• how the research problem will be studied in a summary project design, including patient sample, choice of variables, data collection and analysis methods, and time plan. Please use PICO (population/intervention/control/outcome) for controlled studies
• what the direct patient benefit is from the planned research

The abstract shall provide a summary guide to the purpose and implementation of the research. Please use wording to ensure persons with another subject specialisation can understand the information.

The description may cover a maximum of 1 500 characters including blank spaces (approximately one third of an A4 page in Arial, font size 11, single line spacing).

Popular science description

Describe the project in such a way that a person who is not familiar with the subject can understand it. Describe what is to be done and why, and explain in what way the new knowledge may be important.

The popular science description is an important tool when we inform about the research financed by the Swedish Research Council. If we grant your application, we reserve the right to use the description for information purposes.

Note: The popular science description must be written in Swedish, unlike the rest of the application.

The description may cover a maximum of 4 500 characters including blank spaces (approximately one A4 page in Arial, font size 11, single line spacing).

Research description

Under this tab, please attach your research plan, describe any ethical considerations and motivate any changes made in the application compared to the outline application.

Ethical considerations

Describe the ethical issues raised by the research and how they are managed in the research work.

Research plan

Please attach your research plan in PDF format. The research plan shall consist of a brief but complete description of the research task. The focus of the research plan shall be forward-looking, and it shall cover a maximum of ten page-numbered A4 pages in Arial, font size 11, single line spacing, including references and any images.

The research plan must include the following headings and information, listed in the following order:

• Purpose and aims Present the research problem and the main purpose as well as a short scientific background that justifies the project. Describe the main research question(s) and the primary endpoints.
• Survey of the field Outline briefly (maximum half an A4 page) the background for the research field of evidence-based knowledge and current clinical practice. Mention briefly systematic reviews, national and international guidelines and/or identify knowledge gaps which justifies the need of more research. Please exclude overview of preclinical and technical data and the burden of disease.
• Research questions Structure the purpose in terms of research questions. What is to be studied, and on whom? Please specify the primary variable (primary outcome) of each research question and of any secondary variables as well. The primary variable should be patient-oriented. In treatment effect studies, the effect variable (e.g. difference or percentage change in the primary variable) should also be specified. Justify any use of surrogate variable (surrogate endpoint).
• Variables and measures Describe how each variable will be measured/recorded, in particular, how the measured values will be used in the description and analysis for example, continuous data, binary, categorical, differences, percentage change. What is the role of the variable: is it a primary, secondary, background or explanatory variable? Variables such as quality of life, pain, etc. are commonly assessed on questionnaires/rating scales of various kinds. Specify the dimensions/sub-variables of multi-dimensional questionnaires, as well as the type of scale-categories (e.g. numeric, verbal, VAS), and also how the data will be used in the study. Please include appropriate reference to the questionnaires/rating scales.

• Study design Summarize the specific objectives of the research project in a well specified project design and justify why the proposed design is the most appropriate for the research question. Plans for any interim analyses shall be stated. For intervention studies, all treatments should be described in detail regarding for example type (s) of treatment, dose, monitoring periods, evaluation etc.For controlled trials (RCTs), PICO (Population / Intervention / Control / Outcome) can be used. In controlled cross-sectional studies describe the treatment for the control group. It is not enough to only indicate the standard treatment. Any differences between the routine treatments of the participating clinics should be clearly described. For cohort/observational studies, possible confounders should be identified. Describe how these confounders should be managed. For crossover studies, where the patient is his/her own control, describe the planning of the different treatment periods and how the risk of "carryover" effect etc. should be taking into account.For longitudinal studies, motivate the choice of repeated follow-up sessions. It should be clear which follow-up session that is related to the main outcome of the study. Describe in detail the data collection for register-based studies where patient data is retrieved from the register. All variables shall be stated. For subjectively-based variables, such as PROMs (Patient-Reported Outcome Measures), it is not sufficient to list the names of the questionnaires. It is important to take into account that the registry data of the same variable could have been registered using different types of measuring instruments/assessment forms, which results in non-comparable data. Please limit the references to maximum half an A4 page.

• Project organisation Describe the project organisation, including county councils/regions and clarify your own and the participating researchers’ roles in the project. Describe the added value of including the respective participating researcher and how their participation strengthens the project.
• Estimated sample size and power Explain and justify the smallest difference in treatment effect/primary outcome variable between control and treatment (or equivalent) that is clinically relevant to detect and estimate the sample size of the study/sub-studies. Specify the estimated drop-outs based on references from previous studies or registries if possible. Calculate the power of the study for the planned sample size taking account of the estimated drop-out and where appropriate planned interim analysis. The distribution of patients at the participating clinics should also be considered in the estimation of sample size. Also describe, where applicable, how patient compliance to treatment can be monitored.
• Material: Patient selection – population, sample Briefly describe the inclusion and exclusion criteria for the patient selection. Also describe how the participating clinics contribute to the patient selection. How are the differences in routine treatments handled that could affect the study results? In the selection of patients from the register, indicate the chosen register and consider the risk of systematic under or over registration of patient groups for the inclusion and exclusion criteria.
• Randomization: Describe the randomization method and specify who is responsible for the randomization. Also indicate for whom (patients, physicians, assessors) the randomization is blinded and justify any exceptions.

• Statistical analysis plan Each research question should be linked to a statistical analysis design that is based on the specified variable selection, the methods for data collection and planned management of data for statistical description. The choice of statistical analysis (hypothesis testing) and/or modelling, quality assurance or similar shall be clearly stated. The criteria for any interim analyses shall be stated. It is not enough to set general concepts such as parametric, non-parametric method, descriptive statistics or standard methods for analysis. Note that the normal distribution can be a possible probability distribution for symmetric quantitative data but never for data from assessments of the questionnaire.
  How will dependent data be handled, for example within the group and/or between groups? Which statistical methods are planned for complex data from questionnaires and other subjective assessments, which generates superior category data? How will longitudinal data and drop-out be handled?
  Specify who is responsible for the statistical analysis plan!
• Specific intermediate objectives Present the specific intermediate objectives to be reported and evaluated 18 months after the start of the project. The purpose of the intermediate evaluation is to make sure the project is on schedule, e.g. that the timetable is respected, the patient recruitment corresponds to the expected level and that the quality of the data set is sufficiently high. Examples of intermediate objectives are: the date of approval of the ethical permit, the number of patients included and/or the share of patients with full baseline data (that is to say the actual sample size).

Provide information on the following points under a separate heading if you consider them relevant to your application:

• Equipment. Describe the basic equipment that you, and the team, will have at your disposal for the project.
• Need for infrastructure. Specify the need for international and national infrastructure within the project. Also specify the need for local infrastructure if such equipment depreciation costs are included in the application. Read more about research infrastructure supported by the Swedish Research Council Opens in new window..
• Other applications or grants. If you are applying or intend to apply for several research grants, you need to clarify how the projects relate to each other. This also applies if you have an ongoing grant from the Swedish Research Council with a grant period that wholly or partly overlaps the one you are applying for. You should also justify why you are submitting one or several further applications. Please account for the relationship with any other applications to or grants from other funding bodies (from you or another researcher) for the same project concept.

Justification of changes in the application

Describe the changes that have been made in the full application based on the feedback the project outline received from the review panel. If the change/changes could not be made, explain why!

The outline may contain a maximum of 4,000 characters, including blank spaces (approximately one A4 page in Arial, size 11, single spacing).

Call-specific information

Clinical benefit and health economic considerations

Describe how the project results – in terms of direct patient benefit – are expected to come into practical clinical use within a relatively short period of time (within five years of the completion of the project). Specify and explain in which way the results are being requested by patients and other stakeholders. Factors such as prevalence, the severity of the disease and the cost to society shall be weighed into the description of clinical benefit.

Describe how the project results may contribute to better use of resources within health and medical care, and any potential gain for society as a whole. Discuss the possible health economics considerations that the project results may lead to.

The description may cover a maximum of 4000 characters including blank spaces (approximately one A4 page in Arial, font size 11, single line spacing).

User involvement/Patient participation

Describe the way in which patient participation has been included in the planning of the study and in the choice of primary outcome variables. In addition to patient groups, the concept of patient participation shall include patient organisations, relatives and others who may benefit from the results of the research. If you or anyone else has prioritised among existing gaps in knowledge within the area with the help of patient participation, please describe this. For further information about prioritising processes using patient participation, please see James Lind Alliance External link, opens in new window.. Even if the researcher question is prioritised by a body such as James Lind Alliance, it is necessary to obtain national patient participation. This ensures that patient viewpoints, and also expressed wishes and needs, are taken into account when selecting the primary outcome variables for the study.

The description may cover a maximum of 4000 characters including blank spaces (approximately one A4 page in Arial, font size 11, single line spacing).

Implementation

Describe how the result of the proposed research can be utilised through being implemented in health and medical care. Include a clear level structure and a time plan for implementation. State also the clinical effect goals that shall be used to measure implementation.

The description may cover a maximum of 4000 characters including blank spaces (approximately one A4 page in Arial, font size 11, single line spacing).

National collaboration

State which Swedish county councils/regions, other researchers and companies will collaborate in the project. Describe also any collaboration with foreign equivalents. Describe the positive effects the collaboration may lead to. These may relate to factors such as ensuring a sufficiently large patient sample, access to high-quality data sources, equipment or specialist competency within several disciplines. In case national medical care is applies, please state so.

The description may cover a maximum of 4000 characters including blank spaces (approximately one A4 page in Arial, font size 11, single line spacing).

Please state the number and names of the Swedish county councils/regions that are contributing to patient recruitment in separate text fields. Please make sure the number of county councils/regions corresponds to the number of names selected for participating county councils/regions.

Clinical position

In order to apply for a grant within clinical therapy research, you must hold a clinical position in Sweden, such as a physician, nurse, dentist or physiotherapist, corresponding to at least 20 per cent of a full-time equivalent. Describe in what way you fulfil this requirement.

The description may cover a maximum of 750 characters including blank spaces in Arial, font size 11.

Budget and research resources

Under this tab, please list personnel costs, other costs and any other funding of the project.

Project staff

State the activity level/dedicated time (per cent of a full-time equivalent) of all personnel active within the project, that is to say yourself, other researchers and other personnel. Your activity level as project leader must correspond to no less than 20 per cent of a full-time equivalent.

Please also state the salary you are applying for, for yourself and/or other personnel active within the project, both as a percentage of a full-time salary and as actual annual amounts (including social security contributions). Please state rounded amounts in SEK.

Other costs

Describe other project-related costs (e.g. rental and property charges, operating costs and depreciation costs). Quote the rounded amounts on an annual basis. Only additional costs in connection with clinical studies are covered by the grant, not other health care costs.

You may include depreciation costs for equipment to be used in the project, provided that:

• the equipment has an economic life of at least three years
• the equipment has an acquisition value exceeding a certain amount (please contact your administrating organisation for information about the amount that applies to your department)
• the equipment needs for your proposed project cannot be satisfied through use of national or international infrastructure open to all.

Read more about research infrastructure supported by the Swedish Research Council. Opens in new window.

You may only include the proportion of depreciation costs that corresponds to the use of the equipment in the proposed project. You may not include depreciation costs for equipment that is wholly financed via other grants. Please contact your HEI for information about what is included in local research infrastructure, acquisition values or how to calculate depreciation costs.

Total project cost

Prisma will automatically add up your budget items listed in a table. The total amount you are applying for shall also include indirect costs. You will have to add these to the table yourself. Here you can also add any additional costs covered by the project (for which you are not seeking funding under this call).

Please contact your HEI for information on what constitutes indirect and direct costs.

Explanation of the proposed budget

Justify briefly each cost applied for in the budget stated. The description may cover a maximum of 4 000 characters including blank spaces (approximately one A4 page in Arial, font size 11, single line spacing).

Other funding

Please state any funding for the project received by you or another researcher, in excess of the amount requested in this application. Please state rounded amounts in SEK.

Publications

Under this tab, please attach your and the participating researchers’ publication lists in PDF format to your respective fields.

Applicant’s publications list

Please attach your publications list drawn up according to the headings and information below. The list shall cover a maximum of five page-numbered A4 pages in Arial, font size 11, single line spacing.

1. Selection of publications, List the maximum ten publications of greatest importance to your application. For each publication, please state how you contributed to it, and its relevance to the research project described (maximum four lines per publication). Highlight your name in bold in the author list.

2. Relevant publications from the last eight years, Sort the publications, with your name highlighted in bold in the author list, under each heading (publication type) in the following order:

• Peer-reviewed original articles
• Peer-reviewed conference contributions, the results of which are not included in other publications.
• Peer-reviewed edited volumes
• Research review articles
• Peer-reviewed books and book chapters
• Other publications including popular science books/presentations

Note: Please sort the publications under each heading in reverse chronological order, so that the latest publication is at the top of the list. Please only include articles or corresponding that are published or accepted for publication at the closing date for the call for project outline applications. The author order in the publications list shall be identical to that of the published work. The application cannot be supplemented with publications after the deadline for the call.

Participating researchers’ publications lists

Attach all participating researchers’ publications lists joined up into one file. The list for each researcher shall include a maximum of ten publications, in the form of the most relevant publications for the research described, and shall cover a maximum of one A4 page. The name of the researcher in question shall be highlighted in bold and also be included in the page header of each list.

The publications shall be of the type: Peer-reviewed original articles, conference contributions, edited volumes, research review articles, books and book chapters, and other publications including popular science books/presentations.

Note: Please only include articles or corresponding that are published or accepted for publication at the time of applying. The author order in the publications list shall be identical to that of the published work. The application cannot be supplemented with publications after the deadline for the call.

Administrating organisation

Under this tab, please state the administrating organisation and the project site. The administrating organisation is the organisation that administers the funds awarded and is responsible for it according to the conditions set. The project site is the organisational unit where the project is carried out. Normally, the administrating organisation and project site correspond to the HEI and the department where the project leader is employed.

To allow you to link your application to an administrating organisation, the organisation must have an approved account in Prisma. Please contact your administrating organisation and ask it to apply for an organisation account External link, opens in new window. with the Swedish Research Council if it does not already have one.

If you cannot find your project site, please contact the person responsible for the organisation account at your administrating organisation. You will not be able to finalise the registration of your application if the project site is missing.

Participants

Under this tab, you shall invite the participating researchers and any participating administrators to your application. A participating administrator is a person who is not necessarily part of the project, but can help you to input and edit information in the application.

When inviting participants, please make sure you use the correct email address linked to the person’s Prisma account. You may invite participants who do not already have an account in Prisma, but in order to participate in your application they must register their own personal accounts in Prisma. All participants must accept their invitation, and participating researchers must upload their CV data to the application before you can finalise the registration of the application.

Once a participating researcher has accepted your invitation, you can allocate authority to him/her to edit the application.

CV

Under this tab, please upload your relevant CV information from your personal account in Prisma. Any participating researchers must upload their own CV information to the application. As project leader, please state your experience from coordinating larger research projects and environments under “Other merits”.

The following information, where available, must always be included in each CV, taking into account the stated limitation in numbers:

• Education: First, second and third cycle higher education and specialist degrees.
• Work: Current employment (including type of employment) and longer relevant employment, postdoctoral visits (also included as employment if relevant), research exchanges relevant to the research described and any longer interruptions in the research that have impacted on your opportunity to gain merits as a researcher.
• Merits and awards: Docentship/associate professorship, supervisees (postdoctoral and doctoral students; state the overall number of each category and list the 10 most relevant to you), up to 10 of your most relevant grants awarded in competition, up to 10 of your most relevant prizes and awards, and up to 20 other merits relevant to the application.
• Intellectual property rights: For example, patents and open access computer programs developed by you; state up to 10 of your most relevant.

Registering the application

The tab “Check and register” shows a summary of the fields in your application that require action in order to register it (such as mandatory fields not filled in, text fields with too many characters, discrepancies from limits on the possible project period or budget applied for). The registration of your application is not finalised until you click on the “Register” button.

Note: Everybody you have invited in your application must accept the invitation before you can register the application. If an invitation is not accepted, it must be deleted. Before registration, all participating researchers must also upload their CV information from their own personal accounts in Prisma.

The registered application can thereafter be found in your personal Prisma account in the tab “Applications and grants”, under the menu choice “Applications”. Until the deadline for the call, a registered application may be de-registered, amended and re-registered again as necessary.

It is your responsibility to ensure the application is complete, that is to say the application form is correctly filled in, the correct appendices are attached and the information requested has been provided according to the instructions. Please only submit material specifically requested. We do not accept any additional information after the deadline date, except when specifically requested.

Signing

When you register the application, it is signed by you as project leader. To ensure the application is deemed complete and included in the review process, an authorised representative of the administrating organisation also has to sign the application. The representative is normally the head of the department where the research will be carried out, but this is dependent on your administrating organisation’s structure.

The applicant’s signature confirms that:

• the information in the application is correct and complies with the Swedish Research Council’s instructions
• secondary occupations and commercial ties have been reported to the administrating organisation and that nothing has emerged that breaches good research practice
• the applicant has not been found guilty of scientific misconduct during the last two years before the deadline of the call
• the permits and approvals required have been obtained before the research is started, such as permits from the Swedish Medical Products Agency or approval from an ethical review board or an ethical committee on animal experiments
• the applicant will comply with all other conditions applicable to the grant.

The signature of the administrating organisation confirms that:

• the research or research-supporting activity described can be given room at the administrating organisation during the period and to the extent stated in the application
• the applicant will be employed by the administrating organisation during the period covered by the application
• the administrating organisation approves of the budget in the application
• the applicant has not been found guilty of scientific misconduct by the administrating organisation signing during the last two years before the deadline of the call
• the administrating organisation will comply with all other conditions applicable to the grant.

The above points shall have been discussed by the parties before the representative of the administrating organisation approves and signs the application.

Note: The authorised representative of the administrating organisation must sign the application in Prisma no later than one week (seven calendar days) after the call deadline date in order for the application to be considered further in the review process.

When you have registered your application and the call closes (at 14.00/2 p.m. on the deadline date of the call), the registration of your application is automatically finalised.

Your registered application is automatically forwarded to the representative of the administrating organisation for signature in Prisma. The application must be signed by the administrating organisation no later than one week (seven calendar days) after the deadline. You will receive an email when the application has been signed.

Thereafter you will find information about the status of the application, registration number and signature of the application in your account in Prisma, under the tab “Applications and grants”.

Decision

Shortly after the grant decision has been made, a notice of the grant awards will be published on the Swedish Research Council’s website. You will thereafter find a notice of the decision and a final statement on your application in your personal account in Prisma, under the tab “Applications and grants”. The statement consists of a grading and, in some cases, written comments.

The following applies for funded grants:

A report shall be submitted to the Swedish Research Council 18 months after the grant decision. No later than six (6) months before the report is to be submitted the Swedish Research Council will provide information about the content of the report. For continued funding after 18 months, approval of the report by the Swedish Resarch Council is required.

The Swedish Research Council asks the applicant to confirm that the study has been approved subsequent to an ethical vetting as well as stating the registration number at REPN/CEPN. If this information has not been submitted to the Swedish Research Council after 60 days following the request, the Research Council may discontinue the grant.

The EU ABS Regulation and due diligence declaration: As from 12 October 2015, users of genetic resources (genetic material of actual or potential value) and traditional knowledge relating to genetic resources, obtained after 12 October 2014, shall comply with the EU ABS Regulation (No 511/2014) by making a “due diligence declaration”. This applies only to grant recipients. Due diligence entails the user being able to show that the genetic resource was obtained according to applicable legislation in the country in question and that the possible benefit of the genetic resource will be allocated in a reasonable and equitable way.

Exceptions apply to research into: the human genome, plant genetic material included in Appendix 1 External link, opens in new window. to the international agreement on plant genetic resources, pandemic influenza virus and genetic material obtained from international waters. If you have any questions about the regulations and due diligence declaration, please contact Naturvårdsverket External link, opens in new window..

The scientific evaluation of the application is carried out by active researchers. These peer reviewers evaluate the application in competition with the other applications on the basis of the evaluation criteria set by the Swedish Research Council.

If an application is not completed according to the instructions, this will be weighed into the evaluation.

Review panel External link, opens in new window.

The Swedish Research Council’s conflict of interest policy Opens in new window.

The Swedish Research Council’s gender equality strategy Opens in new window.

Scientific quality is the fundamental criterion when the Swedish Research Council allocates grants to research. Your application is evaluated in competition with the other applications on the basis of the following evaluation criteria.

Evaluation process

Your application is evaluated by a review panel where the members are international researchers.

All members of the review panel assess and grade your application individually. The entire review panel then meets at a review panel meeting to discuss and prioritise the applications, and finally to make a proposal for a decision to the Committee for clinical therapy research.

Each application receives an individual final statement that reflects the review panel’s discussion and overall assessment of the scientific quality of the application.

The applications for research environment grants in clinical therapy research are assessed according to a two-step procedure. First, applicants are required to submit a project outline for evaluation. Applicants, who pass the project outline evaluation will subsequently be asked to submit a complete application.

Evaluation criteria and guiding questions

The evaluation of the scientific quality of your application is made based on four basic criteria (Novelty and originality, Scientific quality of the project, Merits of the applicant, Feasibility). The purpose of using several components is to achieve a multi-faceted evaluation. In addition to the basic criteria, your application is also evaluated using an additional criterion (Benefit of the research – patient value). Due to the nature of clinical therapy research, the Novelty and originality should be weighted lower than the other criteria.

No grading will however be done for the project outlines. The review panel makes an overall scientific assessment based on the five assessment criteria and give the following scores:

• prioritized and asked to file a full application
• rejected

For the assessment of the full application a seven-grade scale is used for four of the assessment criteria: Scientific quality of the proposed research, Novelty and originality, Merit of the applicants and Benefit of the research – patient value. Feasibility is graded using a three-grade scale.

For each criterion, there are guiding questions to support the panel members’ evaluation of your application. These can also function as guidance for you when you write your application.

Novelty and originality (1–7)

Guiding questions:

• Is there a need of more research in this area in accordance to existing systematic reviews, national and international guidelines and/or identified knowledge gaps?
• Have similar studies been conducted before?
• Will the results of the project fill an existing knowledge gap in the clinic?
• Does the project have the potential to deliver implementable results beneficial to patients and society?

Scientific quality of the project (1–7)

Guiding questions:

• Is the project design sufficiently described according to the guidelines for application?
• Is the main research question(s) motivated and specified?
• Is the primary outcome(s) well defined and the most appropriate?
• Is the proposed project design the most adequate design for the objectives?
• Have the target groups (patient groups, patient organizations, family members and others who may benefit from the research findings) been consulted in the planning of the study and the choice of endpoints?
• Are the variables and measurements/assessments, power calculations, sample size and patient selection convincingly described?
• Has the project a clear statistical analysis design that is linked to the research question?
• Has the project national collaboration that involves several county councils/regions, universities or companies in the medical sector?
• If any, which are the limitations of the project design?

Merits of the applicant (1–7)

Guiding questions:

• Does the team have a track record in carrying out this proposed research?
• Has any team member been involved in critical assessments or guideline establishment?
• Is there any involvement of a clinical trials unit or any trial staff (if applicable)?
• Is there an inclusion of a statistician as an applicant?

Feasibility (1–3)

Guiding questions:

• Does the project include the availability and accessibility of relevant personnel, skills, equipment, facilities/ infrastructures and other necessary resources?
• Is it clear who is responsible for the data management?
• Is the recruitment of patients into the study feasible within the time frame of the call?
• Is the time schedule optimal to carry out the proposed project within the timeframe of the call?
• Is the environment suitable for carrying out the proposed research?

Benefit of the research – patient value (1-7)

Guiding questions:

• May the results of the study proposal be directly implementable into clinical practice within the relatively near future, approximately five years after the project ends?
• Does the applicants have sufficient experience, expertise, and network for implementation of the proposed project?
• Factors such as prevalence, the severity of the disease and the social costs should be weighed in the assessment of clinical relevance.
• May the project findings contribute to a better use of the resources in the healthcare sector and to general societal benefits?

Overall grade (1–7)

The above subsidiary criteria are weighed together into an overall grade, which reflects the review panel’s joint evaluation of the application’s scientific quality.