Understanding Oracle Clinical

Joan M. Johnson

May 23, 2007

Abstract

This Short Cut is written to assist you, an Oracle Clinical Developer, with many of the tasks and decisions you may encounter on an occasional basis. These tasks involve study setup and maintenance, account maintenance, handling discrepancies, preparing data sets for analysis, batch-loading data, altering system-level settings and defining standard processes. A working knowledge of screen setup and procedure coding is assumed.

Remote Data Capture (RDC), which moves data entry from the CRO or pharmaceutical company to the sites, is fast becoming the preferred way to gather and clean data for clinical trails. Thus, RDC, in either Classic or PDF form is frequently discussed here; however, occasionally traditional OC data entry methods will be noted.

Ideally, you will have a general programming background as well as a strong knowledge of clinical trials and PL/SQL.

What You Didn't Learn in OC Training

I was first introduced to Oracle Clinical in a nonvalidated environment in 2001. I had experience with PL/SQL, clinical trials, database design, and clinical trail data systems, but had never seen OC. It was a trial by fire, as I struggled to set up a newly installed system, define processes for our new system, configure the new RDC installation, and learn enough OC to set up studies in a few ...

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