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a very basic question

Dear all, apologies if this seems a rather elementary question.

When assigning a CRF to an event in OpenClinica there is a setting for “Required” or not.

I’ve never been sure exactly how this affects the running of a study in practical terms. So say you have an event defined a s “scheduled” with two CRFs - one required, one not - what does that actually mean for the study? Does it affect how the event is marked as complete?

And does it have any critical implications for the extracts/analysis?

And in fact, does the definition of the event (scheduled, unscheduled or common) have a material impact in any way?

Michael


Michael Hannah
Trial Database Manager
Tayside Medical Science Centre
Residency Block
Level 3
Ninewells Hospital & Medical School
Dundee
DD1 9SY

Phone: 01382 383954

The University of Dundee is a registered Scottish Charity, No: SC015096
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