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RE: Question - OpenClinica

Hello, Gabriela -

1. OpenClinica does not have a feature for incomplete dates. If you think that a certain date field will be incomplete in most cases, it may make sense to set it up as the year only (an integer field). However, in the case where the incomplete date is an exception, probably the best way to handle it is to set the date to January 1 of that year, and record a note to file on paper.

2. The handling of this situation, and the double data entry feature in general, has been changed in OpenClinica 2.2. The second person is able to save the data, even though the red warnings appear. A discrepancy note will not appear, but the difference will appear in the log file. The situation needs to be resolved by administrative editing.

In OpenClinica 2.0.1, the second person is not able to save the form . They can enter a discrepancy note for the field and then a study coordinator or a director will be able to view the note. They can then make changes as necessary in Administrative Editing to provide the “correct” value. The user completing initial data entry will not be able to resolve the discrepancy note.

3. To complete a study, it is necessary to lock each event for each patient . Once all the events are locked, the study is completed.

I hope this helps. Please let us know if you have further questions.

Best Regards,

- Jeff

From: Gabriela Prokůpková [mailto:[email protected]]
Sent: Monday, November 26, 2007 10:02 AM
To: Jeff Halperin
Cc: Yufang Wang; [email protected]; Baranníková; Petr Bartík; [email protected]; Lahovský
Subject: Question - OpenClinica
Dear Jeff!

I would like to ask you for answers to my questions mentioned below regarding OpenClinica. We still experience some difficulties during its application.

1) how to enter incomplete date – e.g. in the case only year of diagnosis is known – what to use instead of day/month?

2) how to use Discrepancy management correctly? We would like to employ this procedure especially in double data entry. When the second data entry doesn’t match the initial ones, the discrepancy note (the red warning) will appear. When the corrected record is needed (there is a mistake in an initial data entry) the data entry person has to enter a discrepancy note. What is the right procedure to resolve this situation?

3) How to complete a subject? See the picture below – despite the fact the CRF for all events for both subject are completed and locked the subjects are in a group “discontinued”. Please could you explain the completion of study for a subject (or completion date of the last event)?

Thank you very much for an explanation! I’m sorry to bother you!

Have a nice day!

Best regards
Gabriela

Ing. Gabriela Prokupkova, Ph.D.
Clinical Research Associate
---------------------------------------
A-Pharma s.r.o.
K Ohrade 528/2
155 00 Prague 5
Phone:+420-251 081 244 - personal
+420-251 081 230 - office
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Fax: +420-251 081 247
E-mail: [email protected]
http: www.a-pharma.cz
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