The Hypothetical Patient Posted on November 21, 2007 Take an imaginary participant through the steps of a program, suggests Victoria J. Grochocinski (bio), and you might be able to avoid some data disturbances.

If you wrote your research methods and your human subject sections very specifically, then you’re way ahead of the game in terms of planning for data management. You should know all the data that you’re collecting, but there’s always something missing. And so what you can start to do is review every piece of data.

Take a hypothetical patient through the process. What are you going to do at screening? Will that patient call? Do you want to record that call? How do you want to record that call? What will the IRB allow you to record, and if the patient says, “Yes, I’m interested,” what happens next? Do you make an appointment? Will that get recorded somewhere so that you know if they didn’t show up, you can follow up? And so on down the line. What happens when that patient comes in? I’m going to send them over for a medical exam.

Well, who’s going to schedule that medical exam, and what if there’s a backlog over there and you can’t get the patient in for another week? So these are all things that you can anticipate by running through with that hypothetical patient all of the procedures, and then you will find out what people require.

We have forms that we have to fill out if we want to make patient payments. We have forms that have to be filled out if we’re going to be dealing with pharmacy, so there’s a lot of administrative paperwork that I have never seen written down all in one list, “Do this, do this, do this, do this.” So you have to make your own list because your study is going to be different from everyone else’s.

And ask the people around you for help. Some of the people who can be most informative are assistants working in the office. Maybe they’re greeting patients, and maybe they also do a lot of the paperwork. They’re going to be able to tell you, “This takes this long,” or, “I’m going to send it here and then so and so in that other department always drags their feet,” and find out what the red tape is in your area in the different departments that you’re working with.

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