CSS OCTraining 1 Oracle Clinical Overview/Hands-On

CSS OCTraining 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 released in November 1998

CSS OCTraining 3 Oracle Clinical Overview Key Functions Oracle Clinical Admin Global Library Study Design CRF Modeling Procedures Data Entry Batch Load Discrepancy Mgmt Data Extract Labs

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

CSS OCTraining 5 Oracle Clinical Overview What Can I Do in Oracle Clinical?  Model CRFs for a Study 4 Create the Data Collection Modules (DCMs) and Data Collection Instruments (DCIs) 4 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

CSS OCTraining 6 Oracle Clinical Overview What Can I Do in Oracle Clinical?  Enter Data 4 Manually via Data Entry or electronically through the Batch Data Load facility  Extract Data 4 Create standard views of data in Oracle and SAS 4 Define custom views within a study and across studies  Manage Discrepancies 4 Review and resolve discrepancies; update data 4 Create Data Clarification Forms for Site review  Freeze and Lock Data

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

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

CSS OCTraining 9 Pre-Study Set-up, global study categorizations 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.

CSS OCTraining 10 Set up Clinical Studies 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.

CSS OCTraining 11 Oracle Clinical Overview Clinical Study Set-up Programs (Compounds) Project (Indication) Project (Indication) Study Sites Patients Events Investigator

CSS OCTraining 12 Hands-On