Checklists. Some people hate them; some people love them. There have been whole books written about them. Some checklist fans say they live by their checklists. Cynics may see checklists as long, tedious, ineffective, bothersome, or just plain wrong. And, well, that’s sometimes true.

So what makes a good and effective checklist?

I divide checklists into two types:  Process Checklists and Review Checklists.

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”[1], Atul Gawande calls these “Read-Do” checklists; you Read each step, and then you Do it.

Some tasks that I do involve many 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. The Process Checklist frees me from having to remember what to do, and keeps me from making errors or leaving out key steps. Particularly in a regulated industry like ours, it’s important that each step be done correctly and in the proper order.

Besides keeping me organized and attempting to get things right, checklists keep me from wasting time. They speed me through my routine tasks so I can get on to the more interesting parts. 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.

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. 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. Then I will know that they have a checklist that will help them get the job done right.

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.  Checklists can help ensure that this happens.

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.

Tips for Process Checklists

Here are some tips for creating and using Process Checklists:

  • Number each step, or use checkboxes for completing paper checklists
  • Include a single action at each step, not multiple actions
  • If you use color, use it very sparingly; avoid creating a confusing “rainbow”
    • Consider “graying out” deleted steps if you may want to add them back later
    • Consider color-coding similar steps, or critical steps, if that is helpful

Review Checklists are different. 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. Dr. Gawande calls this a “Do-Confirm” checklist; you do these tasks from memory, then check or confirm that all of the steps were completed.

Examples of Review Checklists

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.

Close-out checklist:

To me, a project close-out checklist is even more important than a startup checklist. 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. It may be more inconvenient and more costly to remedy than if you found it at the outset, but it would likely have been found and addressed. In contrast, close-out tasks such as signing final forms and filing completed documents may never be completed if someone forgets to do them before moving on to the next project. Unlike in startup, there may be no natural check to make sure they were done.

It’s a good idea to keep your checklists short; just those handful or so items that are the most critical and would cause the most harm. For example, when I leave my house to buy a box of cake mix and some frosting, I want to make sure that I have my wallet (to pay for the groceries) and my phone (so I can ask my daughter again what flavor she wanted). I don’t worry about remembering my keys, because without them I wouldn’t be able to leave the driveway. So there is no need to put keys on my checklist.

I have two equations that I have relied on over the years:  Change increases Risk, and Rushing leads to Mistakes. Checklists help me lower the risks and reduce the mistakes. They keep me from forgetting steps in stressful situations when we humans are prone to errors of memory and judgment, and in mundane situations where boredom can lead to accidentally leaving out necessary steps. With a clear, efficient checklist, I might even be able to bake an edible cake.

“Besides keeping me organized and attempting to get things right, checklists keep me from wasting time.”

Barry Mirrer, CIPP/E

Barry Mirrer, CIPP/E

Head of Quality Assurance

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[1] Gawande, A. (2014). The Checklist Manifesto: How To Get Things Right. Penguin Random House.