Implementation of cooperation on quality systems and work processes

The purpose of the development initiative is to contribute to increased quality and effectiveness in the implementation of clinical studies by establishing collaboration between the Quality Assurance (QA) functions in the nodes, and spreading good examples of well-functioning work processes between nodes and other collaborative partners.


Well-functioning quality systems with deliberate work processes and templates are a prerequisite for being able to conduct clinical studies efficiently and with good quality. In order to contribute to this, a previous development initiative was carried out in which the following proposals were made:

  • Initiate local QA functions on all nodes
  • Build a QA network to collaborate and drive work on quality issues and written routines
  • Identify needs and develop examples of SOPs and templates
  • Perform in-depth analysis of needs regarding work processes and written routines for identified areas
  • Collaborate on written routines and templates regarding monitoring
  • Implementing needs analysis linked to written routines and templates that can help and simplify for external partners


The aim is to further develop and implement the above proposals, including providing suggestions on how the nodes will work with QA, how national collaboration will be carried out, and how to make competence available to other clinics, researchers and partners. In addition, it includes getting a functioning QA network for the node organizations in place.

Time plan

The project started in March 2018 and is expected to be completed in Q2 2019. The initiative is divided into the following steps:

  1. Plan the work
  2. Prepare proposals for working methods for QA networks
  3. Needs’ analysis external parties
  4. Develop examples of prioritised written routines and templates
  5. Identify/establish local “QA function” on all nodes, QA networj in place
  6. Report and account for the development initiative