Navigating the critical path to site activation

Site activation rarely goes as planned – ethics committees delay reviews; study coordinators forget to send critical documents; contracts get stuck in legal review; and so on. These delays can potentially derail a successful study before it even gets started, which is why planning and setting your sights on each critical path process is imperative. Even if your end goal moves, you can still hit a bullseye.

The critical path is the expected “plan” and is defined by core milestones. In site activation, these milestones include site selection, site essential document collection, EC submission and approval, contract and budget execution, and IP release. Without the execution of these processes you cannot get sites open, and therefore cannot enroll patients.

Just keeping the end goal in mind, however, is not enough. Many organizations understand the need for planning key activities and milestones, but then they tend to forget them once they’re set. Progress of critical path milestones should be tracked against what was originally expected to help identify bottlenecks, as well as trends for future studies.

Creating and maintaining a risk mitigation log helps anticipate as many plausible delays as possible. For example, if it’s known that a given site’s IRB always defers review of a study for weeks, then an early submission for that site can be planned. Or if a site’s internal process for reviewing changes to site agreements are always causing a risk to meeting deadlines, then maybe developing a Master Study Agreement (MSA) could streamline the number of required steps.

Most delays should be foreseen, but some cannot, which means planning never stops until the last site is activated. When any milestones are re-projected, particularly those that are on the critical path to site activation, there are other important milestones downstream that will be impacted by a delay or study change and those too must be re-planned.

The key lesson is don’t fly blindly. Visibility into planning, re-planning, and progress will help proactively resolve challenges and make for a more successful study start. To learn more strategies to accelerate site activation read about inVentiv Health’s vision and Jen Goldsmith’s June 2016 Applied Clinical Trials article, “A New Approach to an Old Problem – Speeding Study Startup.”