- Ten Quality Decision-Making Practices (QDMPs) have been identified, based on semi-structured interviews with 29 key opinion leaders from pharmaceutical companies and regulatory agencies.1
- Participants at the June 2017 CIRS Workshop reorganised these ten practices, grouping them as
- those that establish who, why and how decisions are made (Practices 1,2 and 3),
- those that ensure decision quality, relevance and importance (Practices 4, 6 and 7),
- those that consider decision alternatives and impact (Practices 5 and 8) and
- those that involve decision transparency and communication (Practices 9 and 10).
- Participants further agreed that documentation is a key marker of quality decision making and specified that documentation for practices 1, 2 and 3 should include documentation of the decision-making framework and weighting criteria and the decision-making standard operating procedures (SOPs), including a rigorous documentation of the roles and responsibilities of decision makers. These decision makers should be accountable for adherence to the SOPs and decisions should reflect their perspectives.
- Documentation of practise 4, 6 and 7 should include documentation of the framework used for evaluating biases, uncertainties that were considered and fully defined triggers for the re-evaluation of the decision.
- Documentation for practices 5 and 8 should include documentation of the alternatives to the decision that were considered and the template that was used to perform an analysis of the impact of the decision.
- Finally, documentation for practices 9 and 10 should include a template to be used for the communication of the decision.
- Donelan R et al. Factors influencing quality decision-making: regulatory and pharmaceutical industry perspectives. Pharmacoepidemiol Drug Safety. 2015;24:319-328.
From Walker S et al. “Quality decision-making practices.” Netherlands: Off Page, 2017. Available at www.cirsci.org/wp-content/uploads/2018/01/CIRS-Book-Quality-Decision-Making-Practices.pdf
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