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Registries

CIRSE takes an active role in the development and implementation of research in cardiovascular and interventional radiology. The Society carries out registries to help bolster the evidence base upon which our dynamic specialty relies. This is done either independently or in collaboration with our fellow societies. This page provides you with an overview of the CIRSE registry model.

Should you wish to get in touch for more information about our registry model or the currently running registries, please don’t hesitate to contact the Clinical Research Department at research@cirse.org.

 

CIRSE Registry Model: 4 quality principles:

  1. Produce high quality clinical data
  2. Conduct ethical research
  3. Conduct clinical research in an efficient and cost-effective manner
  4. Provide a valuable Member Service

 

1. Produce high quality clinical data
All CIRSE-sponsored research shall collect clinical data sufficiently robust to

  • describe in a clinically useful manner a particular patient population/cohort, answer specific questions to support clinical decision-making and/or investigate hypotheses
  • have clearly defined study objectives (a priori)
  • adhere to Good Clinical Practice standards for data collection, transmission, analysis and storage (ISO14155;2011: “Clinical investigation of medical devices for human subjects – Good Clinical Practice”)
  • form the basis for submission to high-impact journals

 

2. Conduct ethical research
All CIRSE-sponsored research shall

  • manage appropriately the risk to the rights, safety and well-being of patients
  • adhere to highest possible standard according to international Good Clinical Practice standards (ISO 14155;2011)
  • adhere to all national and international regulations
  • be conducted in an independent and unsolicited manner

 

3. Conduct clinical research in an efficient and cost-effective manner
All CIRSE-sponsored research shall

  • be conducted according to CIRSE Registry SOPs
  • be professionally project-managed and staffed
  • generate revenue sufficient to cover the costs of expenditure
  • avoid unnecessary and costly data collection and study processes
  • take advantage of Society synergies to save operational costs and maximise dissemination and impact of study results

 

4. Provide a valuable Member Service
All CIRSE-sponsored research shall

  • seek to maximise utility of conducted research for all involved Members
  • where possible, strive to be conducive to the personal data collection interests of centres/researchers
  • seek to avoid unnecessary burden and ensure that electronic data capturing (EDC), forms, regulatory processes etc. are designed in an easy-to-use manner

 

 

CIRSE Registry Model: Stakeholders & Responsibilities

1. CIRSE Society (scientific sponsor)

  • represented by CIRSE Executive Board
  • responsible for scientific and ethical quality of study
  • delegates essential tasks to appropriately qualified Society members/health care providers

 

2. Primary Investigator & Steering Committee (coordinating investigator, investigators)

  • responsible for investigation plan and scientific decision-making
  • multi-disciplinary Steering Committees encouraged by Society
  • PI(s) must be appropriately senior and qualified individual

 

3. CIRSE GmbH (master administrator)

  • project management by Clinical Research Teams
  • responsible for administrating all registry operating procedures
  • host and manage EDC
  • responsible for financial management
  • contracting partner for funder

 

4. Manufacturer (funder)

  • responsible for financial support of project
  • responsible for sharing relevant information and technical advice