A: Your MCC Ambassador is right to caution you against focusing solely on time-based measures. The key to reducing timelines is to remove non-value added work. In other words, avoid protocol amendments, rework, retraining, rescues sites, etc. This is the reason that MCC always recommends a combination of time, cost/efficiency and quality metric types. If you focus on just one, such as cycle time in this case, you may have unexpected consequences on cost and/or quality. For example, when reducing the cycle time to reach a final protocol, you might inadvertently discourage the team from taking the proper time to review the protocol and ensure the best possible quality before study start. This could lead to quality problems, namely avoidable amendments, later in the study with a much larger impact on overall cycle time and cost. The ICH addendum, ICH E6(R2) section 5.0, is very much trying to get the industry to build in quality by design rather than rushing to get started resulting in errors that then need correcting. There are a number of academic studies looking at the costs of poor quality such as the costs of avoidable amendments, non-core procedures, low enrolling sites, subject withdrawals etc. MCC’s Study Quality Trailblazer Work Group developed a Cost of Poor Quality Tool that brings together the available data on these and other costs. It allows you to estimate the costs of quality issues and can be used as a balance to the focus on cycle time. In addition to the Cost of Poor Quality Tool, MCC metrics always include a range of metric types – not just metrics based on time. We recommend implementing more than one metric type to help guard against a sub-optimized outcome.