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Have CDISC Standards Changed the Way We Collect Data

Case report form CRF

CDISC Standards have drastically changed the way we collect data. How many times have we heard that the adoption of standards is a long, slow process? I'm here to tell you - I have seen the result of all of this talk about standards, and it looks like that ocean blue oasis is just peeking over the horizon.

Remember all those comments on paper case report forms?

In 1989, I worked on a clinical study where all the patients were HIV positive and had Pneumocystis Carinii Pneumonia (PCP). The data was vast and messy for every patient. There were pages of concomitant medications, adverse events and labs. The medical history alone was a nightmare to data enter - make that - double data enter nightmare since it was a paper-based study.

Some of the case report forms (CRFs) had a specific spot at the bottom of the page for ‘comments,' and sites were told that comments shouldn't be written elsewhere. However, these CRF pages came to us with study coordinator notes everywhere - in the margins, running outside of text boxes and sometimes up the side of the page.

Many clinical studies have dedicated comment CRF pages. As a data manager in the 1990's I remember thinking that it was important to give the sites a way to tell us things that were not asked for implicitly on the forms. Working as a SAS programmer, I really came to recognize how worthless these comment fields are. Data that can't be tabulated isn't very useful in a submission.

Source: BioClinica Express

I've been involved with developing the CDISC standards since the first CDASH call for participants in 2006.I've been working with databases and standards in some form for a long time. As the joke goes, standards are wonderful, especially since there are so many to choose from!

We have come a long way....

According to the CDASH Standard "It is better to ask specific questions through creation of well-defined data collection fields rather than inconsistently capturing information within general comments data collection fields."

In my poll of forms designers, I learned that over the past few years, out of the hundreds of studies, fewer than 10% used a comment form. This is a big change from studies done 15 or 20 years ago.

Time to Celebrate!

I am convinced that CDISC has influenced companies to stop collecting these comment fields simply by putting it in writing that it is OK to stop collecting this type of data. It gives the clinical programmers an industry-accepted reference that supports their claim that comments are not meaningful data.

What has happened to the need for all these comments? Where did they go? Are we missing something by not collecting these comments? Have we really been able to design forms that collect all necessary relevant data? Do the monitors catch anything missed on the CRFs? Or do they catch anything by reviewing the source? I invite you to share your CDISC and CRF comments and stories with me.


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