Creating CRFs from scratch

Specialties Research

Published

Specializes in MPH Student Fall/14, Emergency, Research.

Hi everyone,

I'm currently in the beginning stages of coordinating a new study. I'm pretty new to this role (just hit 6 months). It's a brand new study (the PI basically just handed me the grant proposal and said here you go, let's get started)

Now that I've hammered down exactly what data points they want to capture and on what days, I need to develop the CRFs. We have lots of CRFs from other studies that I could poach from but I find they are needlessly bloated and I would like to start from scratch.

Can you provide any pointers about creating CRFs and what you do and don't like about the ones you currently use?

This study is observational and will require daily visits to admitted inpatients. I also need an enrollment/baseline package, a discharge package, and a 14-day post-discharge package. I think I will do separate packages for each, and a generic "daily visit" sheet for the other days.

Thanks for your help, Klone (since it feels like it's just the two of us in here sometimes! ;))

ETA: Is MS Word the best Office software for creating paper forms? I'm decently proficient but I'm new to making forms that I will use for hard-copies.

0 Votes
Specializes in Clinical Research.

http://www.amazon.com/Clinical-Trials-Manual-Research-Institute/dp/1405195150/ref=sr_1_1?ie=UTF8&qid=1373760233&sr=8-1&keywords=duke+clinical+trials

I am not affiliated with Duke, but this book is so incredibly helpful. One of our regulatory people found a copy for free as a PDF and posted it online. I have the hard copy, but it's at work right now. I'm pretty sure it has information about creating CRF's. Just look at your endpoints and the data that is needed. Don't forget to put the units of measurement. Some of it seems common sense and then it isn't filled out correctly and you end up with temperature in fahrenheit or celsius and weight in Kg and pounds. It's a little thing, but it drives me crazy when I have to stop to convert. Good Luck! I use word because that's what we have available at work. I'm kind of new to research. I haven't been active on all nurses lately, but I check in every once in a while to see what's posted in research.

0 Votes
Specializes in MPH Student Fall/14, Emergency, Research.

Amazing! Thanks for your help!

0 Votes

When doing CRF's, I don't like having to go on a scavenger hunt through the chart for the pertinent info. For example when information on page 10 of the chart is referred back to several times by the time you get through the whole CRF. I always think "dang man, why couldn't I they just ask for all of this info at once instead of separately throughout." I know it's not always feasible but a little more grouping and less hunting is always appreciated. :)

0 Votes
+ Add a Comment