Clinical studies - step by step

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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

Specific rules for medicines or medical devices
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The design and method of the study are important

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

Statistical analysis plan

Information to study participants before consent

Find out what insurance cover is available for the study participants

Study budget for all the costs in the project

Is a health economics evaluation of the study needed?

Checklist to help plan studies on human

Specific rules for medicines or medical devices
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Applying for an ethical review

Applying for authorisation from a radiation protection committee

Setting up a biobank or getting access to biobank samples

Finding out what applies for handling of personal data

Registering your study before the study begins

SKR and LIF – agreements and templates for clinical studies

Specific rules for medicines or medical devices

What must be submitted to the Swedish Medical Products Agency and the Swedish Ethical Review Authority?

What happens to my notification or application?
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Study participants need to give written consent

Collecting and managing study data

What applies for changes to the study protocol after approval?

Specific rules for medicines or medical devices
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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 medicines or medical devices
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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

Specific rules for medicines or medical devices
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Screening of personal data

Specific rules for medicines or medical devices

How long should the study documentation be kept?

Specific rules for medicines

Producing trial files

In clinical medicine studies, Trial Master Files (TMF), one for the clinical investigator and one for the sponsor, shall be produced at the start of the study and be updated continuously. The trial files shall include the necessary documents for initiating a study, and working documents generated during the process of the study. EMA has recommendations on what TMF should include (pdf, 279 kB) External link, opens in new window.. After conclusion of the study, it shall be possible to reconstruct the study based on the documentation in the TMF. The clinic file shall include all the documentation that is important for the own clinic, and the sponsor file shall include the overall documentation for all participating clinics. Please note that information that may identify patients must not be included in the sponsor file.

Templates for table of contents for sponsor- and clinical investigator trial master files are available here. External link, opens in new window.

Implementing monitoring

Monitoring is a requirement for clinical studies of medicines. The monitoring is carried out by a monitor who is employed by the sponsor or the clinical investigator. A monitor may not be involved in the practical implementation, but must have scientific and/or clinical prior knowledge about:

the product being tested
the protocol
study participant information
the sponsor’s procedures
GCP
regulatory requirements

The monitoring is carried out as a quality control. The monitor shall ensure that the protocol is followed, that laws and regulations are complied with, and that data are correctly registered in the patient’s data collection form (CRF).

Reporting side effects

The clinical investigator in a clinical study of a medicine is responsible for registering and reporting any side effects continuously. The study protocol defines clearly how this is to be done. The definitions and the process differs between medicines and medical devices. As the side effect reporting is important both for the persons participating in the study and for future patients, procedures for side effect reporting must be in place before the study starts.

Ensuring that all data are complete and correct

Once the data collection in a clinical medicine study is completed, the sponsor responsible must go through and ensure that all data input into the database and the data collection forms (CRF) are complete and correct. This shall be documented with the clinical investigator’s signature on each form. In the event of any uncertainty, the clinical investigator should be questioned. The database is declared a “clean file”, once all the data have been checked, supplemented and corrected. After this, no changes can be made to data collected for the study in question, and statistical processing can start.

Summarising an annual safety report

A safety report including a summary of side effect reports (SAE) shall be produced annually for clinical studies of medicines (“Development Safety Update Report, DSUR). The report shall be sent to the Medical Products Agency and to the Ethical Review Authority.

ICH’s guidelines for Development Safety Update Report (pdf, 216 kB)
External link, opens in new window.Medical Product Agency's template for Development Safety Update Report (in Swedish) External link, opens in new window.

Reporting that the study is completed

No later than 90 days after a clinical medicine study has been completed (usually when the last patient has left the study), a common EU document (pdf, 26 kB) External link, opens in new window., End of Trial Notification, shall be sent to the Medical Products Agency, and the study shall be reported as concluded in the same database as the one it was registered in, EudraCT External link, opens in new window..

The study results shall be summarised in a report and be sent to the Medical Products Agency no later than 12 months after the conclusion of the medicine study. If children have taken part, the report must be sent within 6 months of the conclusion of the study. Guidelines are available on EMA’s website at “Structure and Content of Clinical Study Reports” (pdf, 370 kB) External link, opens in new window..