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Clinical and Meta Data Extraction Tasks 2c OPEN Development Conference September 17, 2008

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

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Clinical and Meta Data Extraction Tasks 2c OPEN Development Conference September 17, 2008

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  1. Clinical and Meta Data ExtractionTasks 2cOPEN Development ConferenceSeptember 17, 2008 Phoebe Whitefield Senior Systems Analyst

  2. 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 Data Extraction – Task 2

  3. 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 Data Extraction – Task 2

  4. Non-Repeating Module- Example Data Extraction – Task 2

  5. 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 Data Extraction – Task 2

  6. Repeating Module- Example Data Extraction – Task 2

  7. Repeating ModuleCont’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 Data Extraction – Task 2

  8. Identifying the Repeating Module From Metadata • Repeating attribute is Yes for repeating module Data Extraction – Task 2

  9. 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. Data Extraction – Task 2

  10. 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. Data Extraction – Task 2

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