What is happening in the development initiative? Implementation of cooperation on quality systems and work processes
Ulrika Logren was a project manager within the development initiative “Implementation of cooperation on quality systems and work processes”. The initiative was recently concluded, and in the interview below she tells us what the work resulted in.
Why have we had a quality initiative relating to the implementation of cooperation on quality systems and work processes?
In 2016, a mapping exercise was made of the quality systems that exist in the various node organisations, and a proposal for collaboration on processes, written procedures and templates was produced. The goal of the implementation initiative that was carried out during 2018–2019 was to further develop and implement a number of the proposals to increase efficiency and contribute to achieving the right quality when conducting clinical studies. The templates and support documents produced can be used by all who consider them a help when conducting a clinical study.
What was the outcome of the development initiative?
A QA function has been appointed within all nodes, and a national QA network has been put in place. We have produced a task description for the network, which describes how the new QA network is to work and collaborate, for example. We have carried out more than 20 interviews with researchers, clinics and organisations working with clinical studies, which has provided the basis for a needs analysis of the various templates and support documents requested to make the work easier. Based on this analysis and as a first step, we have produced six templates and support documents linked to medicine studies, which are available to all who may find them helpful.
During the course of the work, we have already seen many positive efficiency gains in the collaboration between the nodes’ QA functions. We avoid work duplication, and we have seen several examples of how nodes can disseminate information more efficiently about changes introduced during the course of the work.
What happens next?
The national QA network is in place, and we have planned two meetings for next autumn, to continue working on producing more templates and support documents based on the requests and needs that have emerged. The QA network will collaborate with other organisations and networks to take the next step and work together to help produce and administer good national templates and support documents and to contribute to spreading knowledge and information. For example, we have contacted the Swedish Medical Products Agency and we will continue our work together with them to find efficient collaboration formats that may make things easier for all.
Templates and support documents produced to date:
- Process overview for medicine studies
- Sponsor responsibility - Checklist
- Investigator responsibility - Checklist
- Contents list investigator folder (ISF) - Template
- Contents list sponsor folder (TMF) - Template
- Study protocol with help text - Template