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Course Introduction
Globally most of the Companies representing IT, Pharmaceutical, Biotechnology, SMO and Contract Research Organizations (CRO) have relied on Oracle Clinical to conduct Clinical Trials, making it the market-leading Clinical
Must be at college level skills in reading, writing, and mathematics (i.e. no remediation needed) and have had high school computer literacy or equivalent.
Life Science Professionals handling complex global clinical trials who –
· Need to rapidly implement electronic data capture software
· Want to run more effective trials and lower/optimize costs
· Do not want to incur the cost nor manage the complexity of IT infrastructure
· Always want current technology and training
· Need world-class data safety, quality, and uptime
· Need to rapidly implement electronic data capture software
· Want to run more effective trials and lower/optimize costs
· Do not want to incur the cost nor manage the complexity of IT infrastructure
· Always want current technology and training
· Need world-class data safety, quality, and uptime
Oracle Clinical & Oracle Remote Data Capture (OC/RDC)
Week 1
· Introduction to Biomedical Informatics: Clinical Trial concepts and definition
· Clinical Trial process, design and protocol
· Clinical data flow and management
· Role of Clinical Trial Teams and key functions.
· Clinical Data Management and clinical programming
· Technology in clinical trials.
· Case Study 1: Clinical Trial Study Case
Week 2
· Introduction to Pharmaceutical business and drug discovery process.
· Drug development process and introduction of phases
· Clinical research & development overview in pharmaceutical industry
· FDA regulation & guidelines & data standards
· Good clinical practices.
· Introduction to data Management and clinical programming.
· Introduction to DBMS and Oracle Clinical.
· Logging into Oracle Clinical and basic menu options.
Week 3
Brief introduction to OC architecture
Explanation of three tier structure
Explanation and brief discussion about relational databases.
· Design and definition of a clinical study in OC
· Use Oracle Clinical to set up studies
Week 4
· Introduction to use of Global library objects.
· Design and definition of DCM and DCI
· Creation of character layouts and screens
· Handover of sample CRF’s for DCM/DCI creation for class practice
· Hands-On Case Study: Set Up a Study Environment and Design a Clinical Study
Week 5
Introduction to creation of CPE’s and Intervals
Role and importance of study sites and investigators
Creation of patient positions and association with study sites.
Creation of default OC views.
Introduction to RDC and graphic layouts.
Week 6
Review of DCM’s and Data entry
Introduction to the validation procedures
Explanation of inner workings of the validation procedures.
Differences in the functionality of online/offline procedures.
Explanation of the working of cursors in the validation procedures
Introduction to the derivation procedures.
Programming of Validation Procedures.
Correlation of QG’s
Use of CPE’s in Validations
Editing generated code for VP’s
User variables in programming of VP’s.
Use of custom code.
Programming techniques for derivation procedures.
Week 7
Review of VP/DP programming
Detailed discussion of OC extracts.
Use of key template and view template in view programming.
Changing the default sequence in view programming.
Customization of OC views.
Introduction to CDISC and SDTM.
Consideration in CDISC programming.
Current interpretation of SDTM 3.1.2 and its impact on clinical trials
Week 8
Clinical Data Management Processes
Case Report Form Design
General Data Flow
Tracking and Logging-in
Preparation of Data Entry
Use Oracle Clinical for Data Capture
Electronic Data Entry Technology
Data entry through RDC
Data Review and Validation/Queries
Week 9
A role of a Clinical Data Management in data verification
Identifying and developing data checks
Data Queries
Using Oracle Clinical to do Discrepancy Management
Data Clarification Forms and its generation using OC
Quality Process
Quality Assurance Audits
Clinical Study Report
Database Release Processes
Using Oracle Clinical to facilitate “Locking” of the study
Statistical Review considerations
Week 10
EDC and its advantage
Current Processes and Technology
Site Source Document verification and approval
Working with the sites on EDC
Explanation of other functionalities of RDC and their importance in Data management.
Use Oracle RDC to manage remote Clinical Data Capture
· Introduction to Biomedical Informatics: Clinical Trial concepts and definition
· Clinical Trial process, design and protocol
· Clinical data flow and management
· Role of Clinical Trial Teams and key functions.
· Clinical Data Management and clinical programming
· Technology in clinical trials.
· Case Study 1: Clinical Trial Study Case
Week 2
· Introduction to Pharmaceutical business and drug discovery process.
· Drug development process and introduction of phases
· Clinical research & development overview in pharmaceutical industry
· FDA regulation & guidelines & data standards
· Good clinical practices.
· Introduction to data Management and clinical programming.
· Introduction to DBMS and Oracle Clinical.
· Logging into Oracle Clinical and basic menu options.
Week 3
Brief introduction to OC architecture
Explanation of three tier structure
Explanation and brief discussion about relational databases.
· Design and definition of a clinical study in OC
· Use Oracle Clinical to set up studies
Week 4
· Introduction to use of Global library objects.
· Design and definition of DCM and DCI
· Creation of character layouts and screens
· Handover of sample CRF’s for DCM/DCI creation for class practice
· Hands-On Case Study: Set Up a Study Environment and Design a Clinical Study
Week 5
Introduction to creation of CPE’s and Intervals
Role and importance of study sites and investigators
Creation of patient positions and association with study sites.
Creation of default OC views.
Introduction to RDC and graphic layouts.
Week 6
Review of DCM’s and Data entry
Introduction to the validation procedures
Explanation of inner workings of the validation procedures.
Differences in the functionality of online/offline procedures.
Explanation of the working of cursors in the validation procedures
Introduction to the derivation procedures.
Programming of Validation Procedures.
Correlation of QG’s
Use of CPE’s in Validations
Editing generated code for VP’s
User variables in programming of VP’s.
Use of custom code.
Programming techniques for derivation procedures.
Week 7
Review of VP/DP programming
Detailed discussion of OC extracts.
Use of key template and view template in view programming.
Changing the default sequence in view programming.
Customization of OC views.
Introduction to CDISC and SDTM.
Consideration in CDISC programming.
Current interpretation of SDTM 3.1.2 and its impact on clinical trials
Week 8
Clinical Data Management Processes
Case Report Form Design
General Data Flow
Tracking and Logging-in
Preparation of Data Entry
Use Oracle Clinical for Data Capture
Electronic Data Entry Technology
Data entry through RDC
Data Review and Validation/Queries
Week 9
A role of a Clinical Data Management in data verification
Identifying and developing data checks
Data Queries
Using Oracle Clinical to do Discrepancy Management
Data Clarification Forms and its generation using OC
Quality Process
Quality Assurance Audits
Clinical Study Report
Database Release Processes
Using Oracle Clinical to facilitate “Locking” of the study
Statistical Review considerations
Week 10
EDC and its advantage
Current Processes and Technology
Site Source Document verification and approval
Working with the sites on EDC
Explanation of other functionalities of RDC and their importance in Data management.
Use Oracle RDC to manage remote Clinical Data Capture
Oracle clinical certification
CLINICAL PROGRAMMER, STATISTICAL PROGRAMMER, CLINICAL SYSTEMS ANALYST
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