Oracle Clinical OverviewHandsOn CSS 1 OCTraining Oracle Clinical

Oracle Clinical Overview/Hands-On CSS 1 OCTraining

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 CSS 2 OCTraining

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

Oracle Clinical Overview What Can I Do in Oracle Clinical? ® Administration 4 ® ® CSS 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 4 OCTraining

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 5 OCTraining

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 6 OCTraining

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

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

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

These modules are used to set up (or design) new studies. this includes identification of the study, patients, visits, sites, and treatment patterns. Set up Clinical Studies 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 10 OCTraining

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

Hands-On CSS 12 OCTraining