Clinical Research and Clinical data management course. Practical hands on training in Oracle clinical with live project. Interview guidance and training material will be provided.

Clinical Data Management(CDM-Oracle clinical Database)

Syllabus (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, ANDA Applications
• ICH-GCP Guidelines
• Responsibilities of Clinical Trial Team
• Protocol and Informed Consent Forms
• Roles and Responsibilities of CDM Team
• CDM Functions
• Clinical Data Management Process and Life cycle
• Data Management Plan and Process
• Electronic Record and Signatures - 21 CFR Part 11
• Case Report Forms, Types of CRFs
• Designing of CRFs
• CRF Annotation and FDA guidelines
• Data Capture Methods and EDC
• Data Entry â?? First pass and Second Pass Entry
• Edit Check Specifications
• Data Validation Procedures
• Discrepancy Management
• Data Clarification Forms (DCFs)
• Database Locking and Freezing
• Data Storage & Archival
• Data Coding and Medical Dictionaries
• SAE Reconciliation

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 treatment patterns
• Creating Investigator, Site Records and Assignments
• Creating Patient Positions and Assignments
• Creating Questions
• Creating Question Groups
• Creating and Maintaining DVG's
• Copy Groups
• Creating DCM's, DCI's & DCI Books
• Validation Procedures
• Derivation Procedures
• Test a Study
• Test Data Entry
• Initial Login
• Key Changes
• First Pass Entry
• Second Pass Entry
• Comparison Reconciliation
• Update
• Browse
• Patient Enrollment
• Missing DCMs
• Data Validation(Batch validation)
• Discrepancy Management
• Data Clarification Forms (DCFs)
• Data Extract and SAS Extract
• Making Mass Changes
• Locking and Freezing
• Lab Subsystem

RDC (Remote Data Capture):

• Data entry in RDC
• Discrepancy Management in RDC
• CRFs in RDC