Once the problem formulation is completed and you know what questions are to be answered and what data need to be collected and analysed, the planning of your clinical study starts.

  • Health and medical care or clinical research?

    Compare your idea with previous research

    Search for knowledge among systematic analyses

    Search for gaps in scientific knowledge

    Use data found in registers

    Formulate the problem

    Good things to consider

    Specific rules for medicinal products or medical devices

    Links and related information

  • Applying for an ethical review

    Research projects in which study participants are irradiated

    Application for access to biobank samples

    Finding out what applies for handling of personal data

    Register your study before the start of the study

  • Study participants need to give written consent

    Collecting and managing study data

    What applies for changes to the study protocol after approval?

    Please consider

  • Planning before the study begins determines how data is handled and analysed

    Studies with a confirmatory purpose

    Studies with an exploratory purpose

    Data handling when the study is concluded

    Analysis of study data

    Specific rules for medical devices

    Links and related information

  • Writing a scientific article

    Selecting the journal

    Publishing with open access

    Publishing the results in a public database

    Informing study participants of the study results

    To consider

    Specific rules for medicinal products or medical devices

    Links and related information

  • Public documents must be archived

    Screening of personal data

    To consider

    Specific rules for medicinal products or medical devices

    Links and related information

It is possible to get guidance on the planning process from Clinical Studies Sweden’s regional nodes or from specialists at your university if you are a researcher at a higher education institute.

The design and method of the study are important

There are many different methods for answering a research question, and the choice of design and method is something that will later on be of great importance for the scientific value of the study.

SBU scrutinises methods in health and medical care systematically, and has published a handbook. External link. describing how various study designs are valued scientifically.

ICH guidelines have been produced as a guiding document for planning medicine studies, but can also be of help when planning other types of therapy studies. ICH guidelines E9 and E10External link, opens in new window. External link. contain information on factors such as blinding, choice of control group, the difference between a confirmatory and exploratory purpose and the importance of outcome measures.

When you have decided what type of data to collect in order to answer the research question, you also need to decide how to collect the data. One way is to construct a case report form, CRF, and you can read more about this below. You should also consider how data collected (completed CRF, surveys, samples, images, register data, etc.) shall be marked up, and whether, once collection is completed, there is a link between the data collected and the identity of the study participant. If it is desirable to have such a link, the basic rule is that data shall be marked in such a way that only a person with access to a code key can identify the person who has provided the data. If there is a plan for how to collect data, mark it and to which persons the data will be available, then it is also easier to describe your data management to study participants, public authorities, personal data officers and other relevant persons who need information during the course of the study.

A research plan is necessary for ethical review applications, and functions as a handbook

Clinical studies carried out in Sweden require approval from the Etichal Review Authority. The ethical review application shall be accompanied by a complete and detailed research plan (also called a research protocol). The research protocol also forms the basis for an application for approval to any other public authorities (see the section on “Special rules for medicines and medical technology”) and shall function as a handbook, so that all parties involved can ensure uniform implementation, but also to make it possible after completion to follow how study data was generated.

The research protocol/plan must include:

  • the scientific question including specific goals and the purpose of the proposed project
  • a survey that summarises previous research results within the research area
  • a project description accounting for the design, selection of study participants, calculation of population size, procedures, methods and definition of primary and secondary effect variables
  • a brief description of the project’s significance to the research area

The website of the Ethical Review Authority includes guidelines for how the research plan shall be designed (in Swedish)External link. External link..

Statistical analysis plan

For open studies, a statistical analysis plan (SAP) shall be in place before the study starts, for blind studies before the database has been locked (further information on statistical analysis is available in the Analysis step). An SAP shall include:

  • detailed definitions of analysis populations
  • analysis variables
  • general description of the analyses
  • exact analysis methods for each analysis variable

Information to study participants before consent

Before a study participant consents to participate in a clinical study, they shall be given access to all the information that a person may reasonably need to know in order to decide whether or not to take part in a research project. Guidelines for how information to study participants shall be designedExternal link, opens in new window. External link. is available on the website of the Ethical Review Authority.

The information to the study participants shall also be designed to comply with the information requirements in the Biobanks in Medical Care Act (SFS 2002:297) and the General Data Protection Regulation (EU) 2016/679. Biobank SwedenExternal link, opens in new window. External link. has produced a biobank guide (in Swedish) where you can read more about the information to be given to study participants specifically on biobank samples. If the study needs to be reported to the Medical Products Agency, there are further requirements on the information to be given to the study participants, see further under the tabs below.

Find out what insurance cover is available for the study participants

The research principal for a clinical study shall ensure that there is insurance to cover any injury that may arise in conjunction with the implementation of the study. You will need to find out what insurance cover there is for the participants in your study, and check whether supplementary insurance needs to be arranged. The application to the Ethical Review Authority shall state whether the Swedish Patient Injury Insurance is valid, or if separate insurance needs to be arranged for the project.

Study budget for all the costs in the project

The funding of the project needs to be secured during the planning phase. There are a large number of Swedish and international research funding bodies, and researchers can also apply for grants and scholarships for which calls are published within the healthcare regions or by HEIs in Sweden, the Nordic countries or the EU.

In order to carry out a clinical study, you should plan for resources in terms of time, money and personnel. A study budget is a calculation of all the costs in the project. The list of costs shall include items such as personnel, training, applications, agreements, data handling, programming, study medicines/medical devices, laboratory samples, statistical analysis, biobanks and administration. Another item in the budget is monitoring, which is mandatory for clinical studies involving medicines and clinical investigation of medical devices. The budget should be followed up regularly during the course of the project.

Is a health economics evaluation of the study needed?

You should also consider whether to add a health economics evaluation to your study. Such an evaluation discovers whether a medical intervention is cost-effective, that is to say whether there is a reasonable relationship between cost and effect as measured in improved health and increased quality of life, or Health Related Quality of Life (HRQoL).

In SBU’s handbook Assessment of methods in healthcare (pdf, 1796 kBExternal link. External link.), you can read more about health economics evaluation. The Dental and Pharmaceutical Benefits Agency, (TLV), has information about health economics evaluation on its websiteExternal link, opens in new window. External link..

Checklist to help plan studies on human

Clinical Studies Sweden has developed different types of support materials. There is, among other things, a template for research person information and consent in clinical studies on medicines as well a checklist that can be helpful if you are planning a clinical study on human and who do not require a permit from the Swedish Medical Products Agency. The documents are intended as an aid and can be downloaded here (in Swedish) External link.

To consider

  • Is the research plan complete?
  • Is there information to and insurance for the study participants?
  • Has a biobank been contacted?
  • Is there a budget?
  • Does the study need to be registered?
  • Is the study a clinical trial? If so, there are special rules concerning allocation of responsibility and data handling.