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Clinical Data Management (CDM)

Clinical Data Management (CDM)

Overview

The clinical data manager plays a key role in the setup and conduct of a clinical trial. The data collected during a clinical trial forms the basis of subsequent safety and efficacy analysis which in turn drive decision making on product development in the pharmaceutical industry. The clinical data manager is involved in early discussions about data collection options and then oversees development of data collection tools based on the clinical trial protocol. Once subject enrollment begins, the data manager ensures that data is collected, validated, complete, and consistent. The clinical data manager liaises with other data providers (e.g. a central laboratory processing blood samples collected) and ensures that such data is transmitted securely and is consistent with other data collected in the clinical trial. At the completion of the clinical trial, the clinical data manager ensures that all data expected to be captured has been accounted for and that all data management activities are complete. At this stage, the data is declared final (terminology varies, but common descriptions are “Database Lock” and “Database Freeze”), and the clinical data manager transfers data for statistical analysis.

Who can do this course?

Anyone who has Bachelor level degree at any science stream, such as B.Sc, M.Sc, B.Pharm, M.Pharm, BAMS, MBBS, BDS, etc.

Prerequisites

Bachelor level degree at any science stream

Curriculum
  • Chapter 1: Introduction to Drug Discovery & Clinical Trial
  • Chapter 2: ICH-GCP Guidelines
  • Chapter 3: 21 CFR Part 11
  • Chapter 4: CDM Process Overview
  • Chapter 5: Protocol document Understanding
  • Chapter 6: Understanding of Different Documents in CDM
  • Chapter 7: Understanding of Different Documents in CDM
  • Chapter 8: Understanding of Different Documents in CDM
  • Chapter 9: Study Set up
  • Chapter 10: Study Set up
  • Chapter 11: Study Conduct
  • Chapter 12: Data Entry and Data Loading
  • Chapter 13: Discrepancy Management
  • Chapter 14: Query writing
  • Chapter 13: Discrepancy Management
  • Chapter 15: Handling of Third Party Vendor Data
  • Chapter 16: Handling of Third Party Vendor Data
  • Chapter 17: Handling of Third Party Vendor Data
  • Chapter 18: Clinical Coding
Features
Real Life Case Studies

Real Life Case Studies

Projects modeled on select use cases with implementation of diverse technology concepts

Assignments

Assignments

All guided classes and courses are mandatorily followed by useful practical assignments

24x7 Expert Support

24x7 Expert Support

Every technical query is resolved on demand with readily available expert assistance

Instructor-led Sessions

Technical session conducted under the guidance of qualified and certified educationists

Course Info

Course Start Date 02/11/2020
Course End Date 03/29/2020
Estimated Duration 3/4 Weeks
Maximum Students 25
Levels Advanced

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