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Oracle Clinical Overview/Hands-On

Oracle Clinical Overview/Hands-On. Oracle Clinical is a comprehensive Clinical Data Management system developed by the Oracle Corporation. It is based on the Oracle 7 Relational Database and Oracle’s Developer 2000 front-end tools.

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Oracle Clinical Overview/Hands-On

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  1. Oracle Clinical Overview/Hands-On

  2. Oracle Clinical is a comprehensive Clinical Data Management system developed by the Oracle Corporation It is based on the Oracle 7 Relational Database and Oracle’s Developer 2000 front-end tools Version 3.1 production released in April 1998; Version 3.1.1 released in November 1998

  3. Data Extract Labs Discrepancy Mgmt Admin Data Entry Batch Load Global Library Study Design Procedures CRF Modeling Oracle Clinical OverviewKey Functions Oracle Clinical

  4. Oracle Clinical OverviewWhat Can I Do in Oracle Clinical? • Administration • Create users, assign access, set up codelists • Set-up a Study • Assign sites, investigators, patients, events, treatment patterns and regimens • Load or create treatment randomizations • Build the Global Library • Create questions, question groups, discrete value groups, extract macros, extract templates • Organize objects into different domains

  5. Oracle Clinical OverviewWhat Can I Do in Oracle Clinical? • Model CRFs for a Study • Create the Data Collection Modules (DCMs) and Data Collection Instruments (DCIs) • Modify the attributes of the DCMs/DCIs to perform univariate checks and to appear as CRFs • Set up Validation Procedures to perform edit checks across questions/visits • Set up Derivation Procedures to calculate derived questions • Set up Labs, Units and Ranges

  6. Oracle Clinical OverviewWhat Can I Do in Oracle Clinical? • Enter Data • Manually via Data Entry or electronically through the Batch Data Load facility • Extract Data • Create standard views of data in Oracle and SAS • Define custom views within a study and across studies • Manage Discrepancies • Review and resolve discrepancies; update data • Create Data Clarification Forms for Site review • Freeze and Lock Data

  7. Global Set-up Study Set-up Study Conduct Data Entry Design Codelists Batch Data Load Users Treatments Randomization Study/Domain Access Extract Data CRF Modeling Labs & Ranges Discrepancy Management Procedures Global Library Views Database Locking

  8. These modules provide an interface for managing users, security, replication, and customization. Typically controlled by a System Administrator or Global Librarian. System Administrative Functions

  9. These modules are used to set up Global Objects that are used in categorizing studies. Typically a common set is maintained across sites. These values are usually maintained by an Administrator and must be in place before a study can be defined. Pre-Study Set-up, global study categorizations

  10. These modules are used to set up (or design) new studies. this includes identification of the study, patients, visits, sites, and treatment patterns. Typically a common set of these objects is maintained across sites (Symmetric Replication can be used). This module also is used to create, load, and manage randomization information. Set up Clinical Studies

  11. Project (Indication) Project (Indication) Study Study Events Sites Patients Investigator Oracle Clinical OverviewClinical Study Set-up Programs (Compounds)

  12. Hands-On

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