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Specific rules for medicines A trial protocol is required for the application to the Medical Products Agency Allocating roles and responsibilities in accordance with Good Clinical Practice Set up systems for data collection, data processing and data
Last modified: 2022-01-03 14.37
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Specific rules for medical devices Design of a medical device study Medical device aspects on ethical review Should the study be reviewed by the Swedish Medical Products Agency? Medical device studies abroad An adapted clinical investigation plan is
Last modified: 2021-09-01 17.07
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Application 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
Last modified: 2022-01-03 15.14
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Specific rules for medicines Applying for authorisation for a medicine study Visa mer Visa mindre Applying for authorisation for a medicine study The purpose of clinical studies involving the investigation of a new medicine may be to discover or
Last modified: 2022-01-03 14.44
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Specific rules for medical devices Notification and application to the Swedish Medical Products Agency Visa mer Visa mindre New rules apply within the EU from 26 May 2021, additional rules apply in Sweden from 15 July 2021. Notification and
Last modified: 2022-01-03 14.48
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Execution 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
Last modified: 2021-09-03 11.14
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Specific rules for medicines Producing trial files Implementing monitoring Reporting side effects Ensuring that all data are complete and correct Summarising an annual safety report Reporting that the study is completed Visa mer Visa mindre Producing
Last modified: 2020-07-06 11.12
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Specific rules for medical devices Medical device perspectives on consent from study participants Summarise documentation in study folders Initiation visit Handling of medical devices in clinical investigation Safety reporting of device deficiencies
Last modified: 2021-09-01 17.08
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Analysis 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
Last modified: 2021-07-08 16.50
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Specific rules for medical devices Medical device with a therapeutic purpose Medical device with a diagnostic purpose Visa mer Visa mindre New rules apply within the EU from 26 May 2021, additional rules apply in Sweden from 15 July 2021. The
Last modified: 2021-09-01 17.08
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Your search resulted in 31 hits
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Development initiatives
The regional nodes that collaborate within Clinical Studies Sweden identify joint national challenges. The nodes collaborate in ‘development initiatives’ to find solutions to these. The development initiatives, funded by the
Office for Clinical Studies Committee for Clinical Studies Regional nodes Cooperation Development initiatives Clinical Studies SwedenLast modified: 2021-11-17 -
Development initiatives
Regulations, research ethics and Good Clinical Practice (GCP) – training for managers on clinical research There has been a need of a training for managers about the regulations regarding clinical research. The initiative was based on the Karolinska
Last modified: 2021-11-24 -
Development initiatives
National network for research nurses – pilot study The aim of the prestudy was to investigate needs and prerequisites for a national network for research nurses. Background Research nurses are important players in clinical studies; for the study
Last modified: 2021-10-25 -
Development initiatives
The aim was to complement the website kliniskastudier.se with neutral, quality assured information on all aspects of clinical studies on medical devices. There would also be summarised information on
Last modified: 2021-10-21 -
Development initiatives
The purpose of the development initiative was to contribute to increased quality and effectiveness in the implementation of clinical studies by establishing collaboration between the
Last modified: 2021-10-21 -
Development initiatives
he purpose was to develop a national standard for R-RCT (Register-based Randomised Clinical Trials) that facilitates and increases the number of register-based randomised clinical studies. The number of randomised clinical
Last modified: 2021-10-21 -
Development initiatives
The purpose was to evaluate the need for support and training from regional node s for researchers carrying out clinical studies with medical devices. Background The regulatory framework for
Last modified: 2021-10-21 -
Development initiatives
he aim was to improve long-term access to good and purposeful statistics, as well as to safeguard continuous analysis and reports on clinical studies. Background Several reports have pointed to the lack
Last modified: 2021-10-21 -
Development initiatives
The aim was to facilitate and shorten the agreement process for researchers, clinics and industry by creating a standardised agreement process (prerequisites, rights and obligations of all parties involved) and in this
Last modified: 2021-10-19 -
Development initiatives
he aim was to develop a national research subject survey. The results of compiled surveys was going to provide statistical data for improvement work at research clinics and to enable adaptations of studies according to the
Last modified: 2021-10-19
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