Clinical Data Management (Theory)

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

• Clinical Data Management

  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

Projects

• CDM Projects

  We will provide CDM Realtime scenarios.

FAQ's

• Can I attend a demo session before enrolment?

  Yes

• What if I miss a class ?

  If you miss a class we can give backup calss for particular session and same session you have to attend another batch also

• 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?

  • Job Support till getting an Opportunity 
  • Resume preparation
  • Mock interviews
  • Placement Assistance

• What Features do you provide?

  • Classroom & Online sessions with corporate trainers
  • Course Material
  • Real time projects with industry experts
  • Regular Assignments (Tasks)
  • Placement assistance
  • Resume preparation
  • Doubts clarifications

Certifications

• Certification

  • 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.