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