Transcript Data_Extraction_2bc_OPEN_CONF_20080917

Clinical and Meta Data Extraction
Tasks 2c
OPEN Development Conference
September 17, 2008
Phoebe Whitefield
Senior Systems Analyst
Repeating Questions
• Terminology borrowed from Oracle Clinical, used in
CDISC - ODM
• Form (CRF) is designed as a collection of Modules
• Module is collection of logically related Questions
– A Module’s questions belong together medically and are
normally answered together during a clinical visit
• Module can be repeating or non-repeating
• Repeating module is the one that contains questions that
repeat
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Non-Repeating Module
• Non repeating module is the one that contains the
questions that are to be answered once
• Ex. Demographics module containing questions such as
Birth date, Ethnicity, and Sex
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Non-Repeating Module- Example
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Repeating Module
• Repeating module is the one that contains one or many
questions for which multiple responses are possible.
• Wherever tabular data is to be collected repeating
modules are used.
– Ex. concomitant medication, adverse agents
• When multiple values are allowed for a question,
repeating module is used.
– Ex. race
• Repeating module allows unlimited number of rows of
responses within the module.
•
Each row is identified with a number called Repeat_sn
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Repeating Module- Example
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Repeating Module
Cont’d
• The Repeating module design jives well the concept of
CDEs. Each column in a tabular structure is identified by
the CDE and the valid values of the CDE become the
allowable response.
• More info available, in the Repeating Question Group (
Oracle Clinical name for Module) document in your
binder
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Identifying the Repeating Module From
Metadata
• Repeating attribute is Yes for repeating module
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ItemGroupRepeatKey in ClinicalData
• ItemGroupRepeatKey identifies the row within the clinical data for
repeating module.
• Within the same row, all the questions have the same
ItemGroupRepeatKey
• A method for extracting the max (itemGroupRepeatKey) for a given
Repeating module in a clinical data file is available.
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Steps for Task 2c
•
Open RegistrationNSABPB42.java
•
Review the code that extracts data for repeating Questions
•
Modify the code to extract data for
–
–
Comments corresponding to Hypertension under Cardiac History
module
All the data from concomitant medications module corresponding to the
agent category Lipid Lowering Drug
•
Set the OpenResponse and OpenRegistration attributes similar 2b.
•
Add code to output result to the console
•
Run OPENPortalProxy.java to verify the data extracted correctly.
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