CR + CDM Theory + Oracle Clinical Software + RAVE

Course Features

• Instructor Live Sessions

  There will be allocated hours of instructor with Live classroom and Simultaneously on Online.
  
• Real-time Case Studies

  Live project based on any of the selected use cases on the above selected Domain. 
  
• Assignments

  Each class will be followed by practical assignments which can be completed before the next class.
  
• 24 x 7 Expert Support

  We have 24x7 support team available to help you with any technical queries you may have during the course and after completion of the course with in a year.
  
• Certification

  Towards the end of the course, you will be working on a project. Covalent certifies you as an course Expert based on the project.
  

Course Curriculum

• CR + CDM theory + Oracle Clinical Database + RAVE Course Content

  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

   

  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

   

  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

Projects

• Projects

  We will provide Real Time Scenarios.

FAQ's

• Can I attend a demo session before enrollment?

  Yes

• What if I miss a class ?

  If you miss a class we can provide recording video for particular session or we can arrange you the back up session. 

• Will I get placement Assistance ?

  Yes

• Do I receive a certificate for training ?

  • Once you are successfully through the course you will be awarded with Covalent's Training certificate.
  • Covalent certification has industry recognition and we are the preferred training partner for many MNCs

• What support is available after the training?

  Doubts clarification up to getting a job

  Resume preparation

  Mock interviews

  Placement Assistance

• What Features do you provide?

  Class Room & Online Live sessions
  Real time projects
  Working faculties 
  Lab facilities
  Placement assistance
  Resume preparation
  Doubts clarification

Certifications

• Course Completion Certificate

  • Once you are successfully through the course you will be awarded with Covalent's Training certificate.
  • Covalent certification has industry recognition and we are the preferred training partner for many MNCs.