EDC, RDE, OCR: We speak the same language–or do we?


Applied Clinical Trials

Applied Clinical TrialsApplied Clinical Trials-02-01-2002

Readers share their experiences

The other day I was talking with a colleague of mine across the pond about the current state of technology in clinical research. We started talking about terminologyabout the meanings and pronunciation of words, the way some people pronounce a certain nut peacan and others say pihcahn.

Pronunciation makes little difference when talking about pecan pie. But in the world of clinical research, with its continual flow of new technologies with unique sets of terms and definitions, differences in pronunciation and meanings can cause problems in our clinical projects. Such problems are rarely as amusing as that created in a room full of cardiologists when an Austrian colleague, who had trouble saying palpate correctly, used the term feel it up. Or theres my friend in France for whom the phrase we have to focus never comes out quite sounding like he meant it to.

Effective communication is one of the three Cs that are key enablers for all relationships (the other two are collaboration and culture). When working with other people its important to know that communication styles differ from culture to culture; the way things are phrased and the timing of conversations are different. In Italy, for example, you use first names only with good friends, and in Japan you never use first names. In the Netherlands you may talk about international affairs but not religion, and in Poland decision making is slow and deliberate. In Texas, it is pihcahns, not peacans. When you understand issues of that sort, youve got it wired!

Recently, I saw a name listed incorrectly next to a Site ID on one of our forms. I repeated several times, No, the name should be Juan to the database administrator (DBA) in charge of entering the names of clinical research associates and their corresponding sites into our electronic data capture system. He finally wrote the number 1 after the Site ID to prevent me from repeating myself a sixth time. Only then did I realize that the DBA was not hearing the name Juan. Accents can trigger miscommunication. Our DBA heard me saying one.

People bring their own expectations, languages, and cultures to an interaction. Keeping this in mind is crucial as we speak with our clients and colleaguesand as they speak with us about their needs and concerns. We must consider the perspective from which they approach our projects and avoid assuming that we understand.

As I continue to work and learn in this new technology environment, Im sometimes perplexed by all the terms people throw around. To some developers, ASP stands for application service provider; to others it means active server page. And dont confuse ASP with ISP (internet service provider). As long as I mentioned developers, Ill lend this other tidbit of advice: They dont call themselves programmers anymore. As when speaking a foreign language, what you hear and what you conceptualize can be two completely different things.

I spent many years traveling back and forth between Austin, Texas, and Europe on business. One of the areas that I tried to improve was speaking other languages so that I could communicate better. In France, I once thought I told the person at the hotel, This is my luggage. Can you have someone take it to my room? What I actually said was, I am baggage. Take me to my room. The intent was there but the meaning just didnt quite come out right.

It took months before I stopped thinking cardiopulmonary resuscitation when hearing mention of CPR, which, as it was being used, stands for computer-based patient record. Terms arent always intuitive, so it takes time to catch on and truly understand whats being said. When Im in a room with techies, and I hear talk about downtime, I need to remind myself that theyre not talking about time spent unwinding after a long, hard day in the clinic. With all of these differencespronunciation, enunciation, and meaningI began to wonder if this is one of the reasons why were having difficulty communicating not only here but globally as wellparticularly on new technology projects.

So is it electronic data capture (EDC) or remote data entry (RDE), and, at the end of the day, whats really the difference? Believe me, I spent some time thinking about this (and, yes, I do have a life). In my intellectual pursuit of logical reasoning, I hypothesized that perhaps people consider remote data entry as a function and EDC as the capture of data in an electronic format. Youll be happy to know with all that brainpower spent, when I researched the topic I found that there was no real difference except that EDC is the newer term for the new systems. The terms have been used loosely and interchangeably globally. CDISC (the Clinical Data Interchange Standards Consortium) defines EDC as:

Collecting or acquiring data as a permanent electronic record (e.g. using data collection systems or applications that are modem-based, web-based, optical mark/character recognition, or involve audio text, interactive voice response, graphical interfaces, clinical laboratory interfaces, or touch screens) with or without a human interface. (CDISC Note: permanent in the context of these definitions implies that any changes made to the electronic data are recorded via an audit trail.)

If a distinction is to be made, according to CDISC, it is this: With EDC, data are actually entered at the point of origin (the investigator site), while RDE implies that the data are entered remotelya rather interesting point of view considering that data are actually being entered at the site where the data are gathered.

Effective communication requires more than recognizing differences and memorizing definitions. It requires respect. The terms of the trade (technology in clinical research) are what they are, and how theyre applied relates to you wherever you are on your learning curve. How you write, how you speak, how you present yourself, your respect for differences, your ability to be flexible, your willingness to see the other point of view, and time and patience will prove fruitful.

With all our differences, we have many similarities. We all want to see our patients improve. We all want our projects to run smoothly. We want to be able to spend more time doing the things that matter to us. We want to have technology available that makes sense. And, we dont mind if its called EDC or RDE. Whats crucial is ensuring that as you roll out an EDC project, you and your vendor are always on the same page. Those who have read my previous Notes from the Field know that my mantra is Always stop and ask questions if youre unsure.1-2 Ask for an explanation of any unfamiliar terms. Dont pretend that you understand. By talking and working toward understanding we can have a global community that bridges the worlds of technology and research.

Use your technology vendors as tutors, of sorts. Learn from them about what you need to focus on. I know, were used to looking up and studying what we dont understand. But when the topic is technology, its also important to communicate with your vendor. Its also much easier than trying to sift through all of the books out there on this topic.

Back to my friend across the pond: We still continue to discuss the varying terminology, even for simple items. What I refer to as a cell phone, some call a mobile and others call a handy. As a friend from Germany explained to me, The phone is handy, you get to talk with anyone at any time, and you never have to go anywhere. Besides, you hold it with your hand. Now, thats intuitive.

1. Donna Hellsten, What to Ask EDC Vendors, Applied Clinical Trials, May 2001, 7882.

2. Donna Hellsten, Planning an EDC Clinical Trial, Applied Clinical Trials, October 2001, 6365.

Donna Hellsten*is vice president of Global Client Services, CB Technologies, Inc., 350 Eagleview Blvd., Exton, PA 19341, (610) 280-7400, fax (610) 280-0440, email: d_hellsten@cbtech.com. She would love to hear your miscommunication stories and encourages readers to send her funny, interesting or poignant stories from the field.Bonnie Dansky,PhD, is client services manager for CB Technologies.

*To whom correspondence should be addressed.

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