Once the approvals required for your clinical study have been obtained, the practical work on the study can start.
The execution of a clinical study shall follow the documentation approved by the Swedish Ethical Review Authority. Further study approvals may be needed, depending on the study design, see Planning External link. and Application External link..
Specific laws, regulations and guidelines apply for the execution of clinical studies using medicines and medical devices respectively.
Study participants need to give written consent
In general, a clinical study may only be conducted if the study participants have given their written consent to participate, and prior to this have been informed about what the purpose is and what participation entails. The Swedish Ethical Review Authority may in some cases approve research without written consent, and more information on this is available in Sections 20–22 of the Act concerning the Swedish Ethical Review of Research Involving Humans (SFS 2003:460). The consent shall be voluntary, expressed and defined.
The study participants shall consent to the research to be conducted, to the personal data handling that participation in the study entails, and that any samples are taken and even if they are saved in a biobank.
The consent shall be documented. All study participants have the right to recall their consent at any time with immediate effect, and then also have the right to have samples already taken for the study destroyed or de-identified.
Special rules for consent apply for persons who are under-age and persons incapable of making decisions. The Swedish Ethical Review Authority provides more detailed information on obtaining consent.
Collecting and managing study data
Data shall be collected in a format that can later be analysed, reported and published in a secure way. A data collection form is created based on the approved research plan/protocol, and should be completed in good time before the study begins. Contact your region's IT department for information on secure data management.
For multi-centre studies, it is important to consider the data collection format and to state clearly how data will be generated, by specifying clearly the methods to be used and by defining units and number of decimals, as well as how lack of data shall be registered in order to ensure data is comparable and to facilitate the analysis work. In most cases, the identity of the study participants shall not be shown in the data collection form; instead, names shall be replaced by a unique study code. A list linking the identity of study participants to their unique study codes shall be drawn up in the event it is necessary to link data to patient identity.
What applies for changes to the study protocol after approval?
If you make any significant change to an application that has been approved by the Swedish Ethical Review Authority, you must apply to have this change approved before it is implemented. An application for a change shall describe the planned changed and its purpose. If the change is significant, for example a change to the study design, the study hypothesis or the group of study participants taking part, an entirely new application for ethical review is required. What constitutes a significant change must be determined from case to case.
- Has consent been obtained from the study participants?
- Is the study following the research protocol?
- Is the data being handled correctly?
- If the study is an intervention study involving medication or medical devices, special rules apply for documentation, monitoring, and reporting.
Advanced therapy medicinal products (ATMP) are human medicines, based on genes, tissues or human cells. They offer ground-breaking new opportunities for the treatment of diseases and injuries. More information about advanced therapy: