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  1. File/document Specific rules for medicines

    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

  2. File/document Specific rules for medical devices

    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

  3. File/document Application

    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

  4. File/document Specific rules for medicines

    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

  5. File/document Specific rules for medical devices

    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

  6. File/document Execution

    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

  7. File/document Specific rules for medicines

    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

  8. File/document Specific rules for medical devices

    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

  9. File/document Analysis

    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

  10. File/document Specific rules for medical devices

    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 18 hits

  1. / English / Good examples / Successful regional research

    Good examples

    – due to luck or infrastructure? Johan Styrke is a researcher and urology specialist at Sundsvall Hospital. Thanks to support from Clinical Studies Sweden among others, he is conducting decentralised research in urology

    Last modified: 2021-08-27
  2. / English / Good examples / Network women’s clinics wants to raise quality clinical research

    Good examples

    Network of women’s clinics wants to raise the quality of clinical research SNAKS is a network involving all women’s clinics in Sweden, and wants to improve the opportunities to conduct clinical multi-centre studies of high quality. Verena Sengpiel,

    Last modified: 2019-10-28
  3. / English / Good examples / Clinical research needs to pay more attention to the fact that human beings are complex

    Good examples

    Clinical research needs to pay more attention to the fact that human beings are complex Foto: Erik Andersson Ulrika Sandén is an author and researcher in innovation technology at the Faculty of Engineering (LTH), Lund University. Through of her own

    Last modified: 2019-10-22
  4. / English / Good examples / Healthcare – a hidden goldmine that can lift clinical research

    Good examples

    Healthcare – a hidden goldmine that can lift clinical research Ola Andersson is a consultant neonatologist at Skåne University Hosptail, and a researcher at Lund University. His research into the advantages of delayed cord clamping of newborns has

    Last modified: 2019-07-05
  5. / English / Good examples / HOPE – unites healthcare and research to benefit children with cancer

    Good examples

    HOPE – unites healthcare and research to benefit children with cancer Every year, 300 children in Sweden are diagnosed with cancer. Thanks to research and new therapies, the majority recover, but still around 20 per cent die from different types of

    Last modified: 2019-07-05
  6. / English / Good examples / KTA Prim increase clinical studies primary care

    Good examples

    KTA-Prim wants to increase clinical research in primary care Malin Frank is a specialist in general medicine and school physician in Stockholm. One day a week, she works as a clinical investigator at KTA-Prim, a reception center where she meets

    Last modified: 2018-11-28
  7. / English / Good examples / Cancer scientist with one foot in the lab and the other in the clinic

    Good examples

    When Eva Hellström Lindberg was a newly appointed doctor, she met a number of patients with a mysterious blood disease that had no name at the time. It wakened her curiosity and

    Last modified: 2018-11-28
  8. / English / Good examples / We build research infrastructure for the future

    Good examples

    Emma Larsson at Gothia Forum in Gothenburg has worked with the research project SCAPIS for almost five years. She is responsible for coordinating work between the six participating cities, which means

    Last modified: 2018-11-28
  9. / English / Good examples / We need more scientific studies that include children

    Good examples

    Children and adults digest and react to medicines in different ways. Despite there being differences, many medicines have not been studied in children, and knowledge about long-term effects and

    Last modified: 2018-11-28
  10. / English / Good examples / Linköping's SCAPIS-project got most yes replies

    Good examples

    Linköping’s SCAPIS project got most “yes” replies It was a challenge to gain acceptance of the SCAPIS project throughout the organisations at both Linköping University and Region Östergötland. However, in June 2018, the last study participants will

    Last modified: 2020-02-18
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