Cover image for Understanding Oracle Clinical

Book description

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.

Table of Contents

  1. Understanding Oracle Clinical
    1. General Architecture
      1. TEST and PROD mode
      2. Modes and Tables
      3. RESPONSES
      4. Received DCMs
      5. Received DCIs
      6. RDCI_HISTORY
        1. Verification
        2. Locking
      7. DCI_BOOK_PAGES
    2. GLIB
      1. Domains
      2. Questions
        1. Qualifying questions
        2. Extended attributes
        3. Online question-level help
      3. Question Groups
      4. Discrete Value Groups
        1. DVGs for qualifying questions
        2. Thesaurus DVGs
        3. Alpha DVGs
      5. Global Librarian
    3. Building a Study
      1. DCMs
        1. Screen layouts
        2. Question group attributes
        3. Question attributes
      2. DCIs
      3. Clinical Planned Events
      4. DCI Books
      5. Study Views
        1. View templates
        2. Union and cross-study views
        3. Import views
        4. Removing views
    4. Discrepancies and Derivations
      1. Basic Discrepancy Management
      2. Automatic Checks
      3. Routing in RDC
      4. Online Versus Offline
      5. Batch Validation
      6. Derivation, Procedure, or SAS Check?
      7. Advanced Procedures
        1. View of the cursors
        2. RXC_DATE.CONVERT
        3. UPDATE_PAT
        4. Custom code
    5. Study Maintenance
      1. Mass Changes
      2. Batch Loading
      3. Labs
    6. Other Information Sources
      1. OCUG
      2. MetaLink
      3. Technical Reference Manual
      4. Smoketest
      5. API
      6. CDISC
      7. CDASH
    7. About the Author