1. Goals and documentation of quality decision-making practices
From Walker S et al. Quality decision-making practices. Available at
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:
From Walker S et al. “Quality decision-making practices.” Netherlands: Off Page, Available at