That’s because if you miss a step in the startup process, there is a good chance that it would be noticed at some point during the project. To me, a project close-out checklist is even more important than a startup checklist. When starting a clinical (or any) project, a startup checklist can help ensure that you haven’t missed any critical steps in setting up the project such as creating plans (e.g., project plans, data management plans, safety management plans, clinical monitoring plans), setting up systems (e.g., EDC, CTMS, eTMF), requesting accounts, creating forms and templates, notifying stakeholders, etc. Examples of Review Checklists Startup Checklist: Gawande calls this a “Do-Confirm” checklist you do these tasks from memory, then check or confirm that all of the steps were completed. Instead of using a Process Checklist to perform a task, a Review Checklist is used after task completion to make sure that no steps were missed, or to make sure that all aspects of a review have been completed. Consider color-coding similar steps, or critical steps, if that is helpful.Consider “graying out” deleted steps if you may want to add them back later.If you use color, use it very sparingly avoid creating a confusing “rainbow”.Include a single action at each step, not multiple actions.Number each step, or use checkboxes for completing paper checklists.Here are some tips for creating and using Process Checklists: I keep my Process Checklists in a format that lets me change them easily, should I think of an additional step that needs to be added, or if I discover a better way to organize one of the steps. Checklists can help ensure that this happens.

In full-service CRO such as PROMETRIKA, groups representing many different functional areas ( clinical operations, regulatory, data management, biostatistics and programming, pharmacovigilance, medical writing) interact and coordinate, making it important that each team perform their tasks completely and successfully so that other groups are not negatively impacted. Then I will know that they have a checklist that will help them get the job done right. I always keep in mind that I could share the checklist or hand it off to another member of the team I keep the details specific enough so that someone else can understand them. Particularly at work, I try to write these Process Checklists in a clear way, with enough detail to remind me what needs to be done.

Without a checklist, I might forget to do one of those simple, mundane tasks that later comes back to haunt me and takes valuable time to fix. They speed me through my routine tasks so I can get on to the more interesting parts. Particularly in a regulated industry like ours, it’s important that each step be done correctly and in the proper order.īesides keeping me organized and attempting to get things right, checklists keep me from wasting time. The Process Checklist frees me from having to remember what to do, and keeps me from making errors or leaving out key steps. For these I use a Process Checklist so that I don’t forget any steps, and to make sure I do them in the correct order. Process Checklists are like a recipe for baking a cake: you perform each step as it appears in the checklist. In his book “The Checklist Manifesto”, Atul Gawande calls these “Read-Do” checklists you Read each step, and then you Do it.

Checklist manifesto baking a cake