Tripack

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

• Cinical Research, CDM & Pharmacovigilance 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 Enrollment
  • 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

   

  Pharmacovigilance/ Drug Safety  theory:

  • History and overview of Pharmacovigilance
  • Regulatory Authorities country wise
  • Pharmacovigilance in India
  • Spontaneous reporting
  • Active pharmacovigilance
  • Cohort Event Monitoring
  • Adverse Events and its types
  • Drug Safety in clinical trials and post marketed drugs
  • Different sources of Adverse Events reporting
  • Different types of AE Reporting Forms
  • Expedited reporting and its timelines
  • Aggregate reporting
  • Different departments working on Pharmacovigilance
  • Business workflow of Pharmacovigilance
  • Minimum criteria for the case
  • Causality assessment of the adverse event
  • Expectedness assessment of the adverse event
  • Seriousness assessment of the adverse event
  • MedDRA and WHODD coding
  • SAE narrative writing and Templates
  • PBRER/PSUR and its submission timelines
  • E2A-E2F Guidelines
  • PADAR
  • Explanation of Safety Signals, Signal Detection at UMC
  • Signal publication and communicating signal
  • Risk management

   

  Practical Hands-on Training on Oracle Argus Safety Database :

  Argus Console:

  • PV Business process
  • Introduction to Oracle Argus Safety Database
  • Family, Product and License creation
  • Clinical Study configuration
  • Access management : Sites, users and Groups creation
  • Workflow Configuration
  • Case priority Configuration
  • Case Numbering
  • LAM case Numbering
  • Field Validation
  • Code list Configuration
  • Field label Configuration
  • Auto narrative Configuration

  Argus Safety Module:

  • Different icons used during the case processing and their purpose.
  • Different tabs used in case processing
  • Case Bookin and Data entry
  • Case Processing of ICSR
  • Case Triage
  • Performing Validation
  • Case Routing Based on workflow
  • Case Quality check, Medical review
  • Duplicate case check or verification
  • Report Generation for Regulatory Submission
  • Expedited Reports and Aggregate Reports
  • Creating PSURs, CTPRs, NDA and IND reports
  • Creating Case data analysis reports
  • Unblinding the clinical trial cases
  • Locking and unloking Case
  • Follow Up for Case
  • Query generation : Action Items
  • Resolving queries using contact Logs
  • Case Bookin in LAM and Routing to Central Safety database
  • MedDRA coding and WHO DD coding
  • Narrative Writing

Projects

• Projects

  We will provide Real Time Scenarios on CR & CDM & PV.

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