For researchers

For researchers

The “For researchers” pages are primarily aimed at researchers who want to conduct or learn more about clinical studies. Here you can find information about the study process, different study types and the laws and regulations that

Clinical studies - step by step

For researchers

The pages in “Clinical studies – step by step” are aimed in the first instance at persons working within healthcare and research who want to know more about the study process, and what needs to be considered when

Idea

For researchers

When you have an idea and want to find out whether it is sound, it is a good idea to start by making an inventory of what is already documented in the area. By carrying out a literature search and a review of registers and databases, you can map

Planning

For researchers

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. Page contents: Page contents: The design and method of the

Application

For researchers

It is easier to apply for authorisation for a clinical study if thorough preparations have been made and there is a well worked out and detailed research plan. Once the research plan is completed, you must apply for authorisation from the

Execution

For researchers

Once the approvals required for your clinical study have been obtained, the practical work on the study can start. Page contents: Page contents: Study participants need to give written consent Collecting and managing study data What applies

Analysis

For researchers

It is a good idea to consult a statistician already during the planning phase to enable the production of correctly analysed data and publication of the result. Early preparation is crucial for producing a good study design, the correct

Publication

For researchers

Once the results of the study are complete, it is time to start writing your report or article for publication in a scientific journal or other forum. Page contents: Page contents: Writing a scientific article Selecting the journal

Archiving

For researchers

When a clinical study is completed, research materials including data and documentation need to be prepared for long-term storage. It is important to research documents are stored and archived in a structured way in order to enable scrutiny