• Call For Abstract Is Open. Closing Date: 31 August 2018

  • Organized By Selangor Central Zone Cluster Hospitals CRC : CRC Klang, CRC Shah Alam & Hospital Banting

  • Call For Abstract Is Open. Closing Date: 31 August 2018

  • Organized By Selangor Central Zone Cluster Hospitals CRC : CRC Klang, CRC Shah Alam & Hospital Banting

Copyright 2018 - Selangor Central Zone Cluster Hospitals - Empowering Cluster Through Reserach.

ISR

Course Description

The Fundamental of Clinical Research & Practice Course is an introductory training that provides the fundamental information to understand clinical research. It includes Overview of Drug Development, Non-Clinical study, Trial Phases involved and the objective of every phases. The course will also cover the most important guideline in conducting clinical research, Principles of Good Clinical Practice and brief discussion of Roles and Responsibilities of players in clinical research (Institutional Review Board/ Independent Ethics Committee, Investigators and Sponsor).

Course Objective:

At the end of the course, the participant will acquire knowledge and understanding the following:

  • Define what is drug/product
  • Describe phases of drug development
  • Describe 4 phases of clinical research
  • Describe the Principles of GCP guidelines
  • Identify IRB/IEC, investigators and sponsor roles and responsibilities
  • Define what is Essential Documents in clinical research
  • Describe investigational product/drug management

 

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