Aligning Timelines for Better Coordination
Increased complexity of launching and running research protocols means different teams are contributing their expertise to ensure human subject protection, accurate budgets and successful patient recruitment. It also means that, with so many disparate groups involved, the risk of delays increases.
One significant contributor to delays in study start-up is the lack of a common understanding for the overall timeline. Each group may know what it is responsible for, but may not be aware how its actions impacts others. An IRB approval can be in place for months while another team still wrestles with the budget or contract with the sponsor. This disconnection can lead to lengthy study start up times and put an institution at a disadvantage in achieving success in its research programs
These are a few best practice tips for keeping everyone on track:
- Appoint a quarterback. Even if your institution does not have a centralized approach to study start-up, it’s critical that at least one person is responsible for setting the calendar, communicating with different teams and setting expectations. This requires having a general understanding of the processes of different committees, such as the pharmacy or radiation safety committee.
- Create a master calendar. Developing and sharing a master calendar, including dependencies, is a fundamental pillar of successful project management. This should include the schedule of all committee meetings. This kind of “big picture” calendar helps identify if there are risks to the schedule. Ideally key stakeholders in the start up process (Investigator, Coordinator, CRO, Sponsor) will collectively decide on a timeline consistent with industry expectations. Do we want to say suggest a completion date goal and share it w the sponsor?
- Have regularly scheduled check-in meetings. Depending on the volume of your studies, this can be a weekly meeting with representatives of each of the teams or committees to discuss the status of each and identify risks of delay. This gives everyone an opportunity to understand the impact of one team on the whole. As an added bonus, this kind of collaboration across teams can encourage creative problem solving to get past hurdles.
- Schedule regular email updates. Yes, we have too much email. But a weekly, perhaps every Monday morning, email to everyone on each of the teams that outlines what is critical that week, will keep everyone on track. This builds transparency to the process and creates accountability.
- Coordinate with the sponsor. There are times when a sponsor is unaware that a research site has reached a particular timeline milestone, which can impact their ability to provide needed information. Sponsor processes also need to be connected to the timeline.
The two most important factors in ensuring on-time clinical study start-up are transparent communication and team accountability. These coordinated best practices can help to ensure a successful, on-time program.