Clinical Research Theory :
• Introduction to Clinical Research
• INDA, NDA, ANDA applications
• Types, Designs and Phases of Clinical Trials
• ICH GCP guidelines (ICH E6)
• Roles and Responsibilities of Investigator and CRA
• Roles and Responsibilities of Sponsor and CRC
• Contract Research Organizations-CRO
• Case Report Form and its Contents with live example
• Contents of protocol
• Explanation of Research protocol with live example
• Informed Consent Form
• Institutional Review boards(IRB)/IEC
• Participant safety and Adverse events reporting
• Safety definitions and reporting requirements
• Monitoring of Study at participating sites
• Source Data Verification
• Investigator's Brochure (IB)
• Standard operating procedures
• Essential documents
• Data Coding using MedDRA and WHODD
• CRF Design Guidelines
• SAE/AE Reconciliation
Clinical Data Management Theory :
• Introduction to Clinical Data Management
• Clinical Data Management Process and Life cycle
• Explanation of Study Start Up / Set up
• Explanation of Study Conduct
• Explanation of Study Close out
• Clinical Data Management Plan with Example
• Case Report Forms, Types of CRFs
• Designing of CRFs
• CRF completion Guidelines(CCGs) with Example
• CRF Annotation
• Data Capture Methods and EDC
• Data Entry – First pass and Second Pass Entry
• Edit Check Specifications
• Data Validation Procedures
• Discrepancy Types (Univariate, Multivariate, Manual and Indicator)
• Discrepancy Management
• Query Resolution
• Data Clarification Forms (DCFs)
• Database Locking and Freezing
• Pre closure Checks
• Data Coding and Medical Dictionaries
• SAE Reconciliation
• 21 CFR Guidelines
E-Mail ID: [email protected] Phone: +91-9848733309/+91-9676828080
www.covalenttrainings.com
Practical Hands training on Oracle Clinical Database/RDC :
• 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
• CRF Design
• Creating Questions
• Creating Question Groups
• Creating and Maintaining DVG's
• Creating DCM's, DCI's & DCI Books
• UAT(User Acceptance Testing )
• Test a Study
• Test Data Entry
• Initial Login
• Key Changes
• First Pass Entry
• Second Pass Entry
• Comparison Reconciliation
• Update
• Browse
• Patient Enrolment
• Data Validation(Batch validation)
• Discrepancy Management
• Data Clarification Forms (DCFs)
• Audit Trail
• Locking and Freezing
RDC (Remote Data Capture):
• Data entry in RDC
• Discrepancy Management in RDC
• CRFs in RDC
E-Mail ID: [email protected] Phone: +91-9848733309/+91-9676828080
www.covalenttrainings.com
Medidata RAVE EDC training:
• Introduction to Rave EDC and Understanding EDC
• Logging into Rave EDC
• Benefits of Rave EDC
• Understanding Menus and Icons in tool
• Selecting Study, Site and subject
• Browsing in the tool
• Accessing CRF pages (form layout)
• Understanding subject home page
• Adding New subject
• Task Summaries
• Assessing form pages with open queries
• Discrepancy Management (Query resolution)
• System Queries and Manual Queries
• Query Writing
• Adding Stick notes and protocol Deviations
• Lab and lab ranges Configuration
• Accessing Audit trail
• Auto-coding and manual coding with MedDRA
• Data entry lock and hard lock
• Data review and verification
• Accessing Folders and forms from Grid view
• Accessing and adding the log forms
• Handling missing data
• Electronic Signatures and batch Signature Functionality
• Exercises on Adding subject, accessing CRFs, identifying Discrepancies, resolving
queries, adding additional events and adding log forms
E-Mail ID: [email protected] Phone: +91-9848733309/+91-9676828080
www.covalenttrainings.com
