Quality of Decision-Making Orientation Scheme (QoDoS) tool
Goal/purpose
Assess and improve decision-making processes and practices
Overview
The Quality of Decision-Making Orientation Scheme (QoDoS) tool is designed to assess the quality of decision‑making practices at both individual and organisational levels. It explores behaviours, attitudes, and procedural elements that influence how decisions are made, communicated, and documented within regulatory authorities, HTA agencies and industry. By identifying patterns that support or hinder high-quality outcomes, QoDoS enables organisations to strengthen consistency, transparency, and robustness in their decision-making processes. Results can inform targeted training, leadership development, and organisational change programmes.
Who the tool is for
Regulatory authorities, HTA agencies and industry.
How the tool works
The QoDoS tool is implemented as a questionnaire completed by individuals – such as reviewers, managers, committee members – and analysed by CIRS to assess implementation of the 10 Quality Decision Making Practices (QDMPs). The tool measures how individuals implement QDMPs into their decision making, as well as their perception of the organisation/department/committee.
Practical global experience
The QoDoS tool has been completed by over 15 regulatory agencies in Asia, Africa, North and South America, Australia, and Europe. The results provided a basis for discussion of decision-making issues within teams and the broader organisation. They also demonstrated how agencies have implemented QDMPs and led to recommendations for improvement across reviewers in pre- and post-market departments, decision-making committees, regulatory management, and senior leadership. Companies and HTA agencies have also used the tool (Bujar et al., 2020) to enable a global analysis of stakeholder decision-making practices.
WHO Global Benchmarking Tool (GBT) indicators supported by the tool
- GBT RS02.02: Channels of communication and decision‐making are clearly established among the structures, institutions, and departments forming the NRA
- GBT MA04.01: Documented procedures/tools are implemented for the assessment of the different parts of the application and for the assessment of specific requirements of specific classes of medical products (quality, safety, and efficacy)
Resources
- Donelan R, Walker S, Salek S. The development and validation of a generic instrument, QoDoS, for assessing the quality of decision making. Front Pharmacol. 2016;7:180
- Bujar M, McAuslane N, Walker S, Salek S. The reliability and relevance of a quality of decision-making instrument, Quality of Decision-Making Orientation Scheme (QoDoS), for use during the lifecycle of medicines. Front Pharmacol. 2019;10:17
- CIRS publications on decision making
- CIRS R&D Briefing 87: Roadmap for Regulatory Strengthening: CIRS Tools for Measuring and Optimising Regulatory Performance to support practices in line with the World Health Organization (WHO) Global Benchmarking Tool (GBT) indicators