CDM, Oracle Clinical Database Course Content

(Clinical Research & Clinical Data Management):

• Introduction to Clinical Research and Clinical Data Management
• Introduction to Oracle Clinical Database
• Different Phases of clinical trials
• INDA, NDA Applications
• ICH-GCP Guidelines
• IRB
• IB
• 21 CFR part 11
• SOP
• Responsibilities of Clinical Trial Team and CDM
• Protocol and Informed Consent Forms
• Clinical Data Management Process and Life cycle
• Data Management Plan
• Case Report Forms, Types of CRFs, contents
• Designing of CRFs
• CRF Annotation
• Data Capture Methods and EDC
• Data Entry – First pass and Second Pass Entry
• Edit Check Specifications
• Data Validation Procedures
• Discrepancy Management
• Data Clarification Forms (DCFs)
• Database Locking and Freezing
• Data Coding and Medical Dictionaries
• SAE Reconciliation
• CCG with live example

Oracle Clinical Database Syllabus

• Introduction to OC window
• Subsystems in OC
• Defining Programs and Projects
• Defining Organization Units
• Defining Regions
• Defining Planned Studies
• Easy Study Design
• Creating Intervals
• Creating Events
• Creating Investigator, Site Records and Assignments
• Creating Patient Positions and Assignments
• Creating Questions
• Creating Question Groups
• Creating and Maintaining DVG's
• Creating DCM's, DCI's & DCI Books
• Test a Study
• Test Data Entry
• Initial Login
• Key Changes
• First Pass Entry
• Second Pass Entry
• Comparison Reconciliation
• Update
• Browse
• Patient Enrollment
• Data Validation(Batch validation)
• Discrepancy Management
• Data Clarification Forms (DCFs)
• Locking and Freezing

RDC (Remote Data Capture):

• Data entry in RDC
• Discrepancy Management in RDC
• CRFs in RDC
• Features
• Resume preparation
• Assignments
• Assessments
• Interview Questions
• Mock Interviews
• End to end Project
• Direct Access to CDM Database