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What is happening in the initiative: Cooperation on quality systems and work processes

2017-11-15

Ulrika Logren has been project manager for the development effort Cooperation on quality systems and work processes. The initiative is now completed and you can read more about what the outcome has been and what will happen next in the interview with Ulrika below.

Ulrika Logren

Why did we invest in an initiative on cooperation on quality systems and work processes?

Good quality systems with thoughtful work processes (SOPs) and templates are a prerequisite for being able to conduct clinical studies efficiently and with good quality. By spreading and sharing good examples of these practices and documents, between nodes and other partners, we can contribute to improved quality and effectiveness in the execution of clinical studies.

The aim of the development initiative was therefore to get information on the quality system of the node organizations, to disseminate this information and to formulate proposals for collaboration on processes, written procedures and templates based on a needs analysis.

What was the result of the development initiative?

Based on the survey, a needs analysis was carried out and proposals were made for activities and follow-up projects that could contribute to increased quality and efficiency. The proposals included to:

  • set up local ”QA functions” on all nodes
  • start a quality network/QA network
  • provide examples of SOP:s, work processes, and templates
  • conduct an in-depth analysis of needs in data management and statistics
  • continue working with common documents and routines related to monitoring
  • perform a separate needs analysis to identify needs that may simplify for other clinics and external parties

What happens next?

It has recently been decided by the Committee for Clinical Studies that an initiative including planning implementation of the proposals can start. Representatives from the nodes will be appointed by the end of 2017 and the work is scheduled to be completed in 2018.

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