Training Detail

Course Title : Training Course on Good Clinical Practice (GCP)

Duration: 23 Aug, 2020 - 25 Aug, 2020


Hosted by : icddr,b

Published On : 04 July, 2020

Close Date : 16 August, 2020

Location : Zoom online Platform View Detail

Training Course on Good Clinical Practice (GCP)(Online)

Date: 23-25 August 2020

Venue: Zoom Online Platform

 

Introduction

Good clinical practice (GCP) is a global quality standard for conducting clinical trials that is provided by International Council for Harmonisation (ICH); an international body that defines a set of standards for clinical trials involving human subjects. It provides a framework of principles which intend to ensure the safety of research participants and the integrity and validity of data. This three-day online course aims to provide the researcher with the basic principles of GCP and how these principles can be applied practically in the research setting. The course is aimed at all those involved in clinical research.

 

Learning objectives

At the end of the course the participants will be able to

  • Understand the principles underlying GCP.
  • Understand the resources required to design GCP compliant clinical trial.
  • Understand how to conduct GCP compliant clinical trial.
  • Understand roles and responsibilities of different players in clinical trial.
  • Understand the documentation required to run GCP compliant clinical trial.

 

Course contents

  • Overview of ICH-GCP
  • Clinical trial- design, registration, protocol development and Investigator’s Brochure
  • Ethical principle in clinical research
  • Roles and responsibilities of different players in clinical trial (Ethics committee, investigator, sponsor, clinical trial monitor)
  • Informed consent and documentation
  • Clinical Safety monitoring and reporting
  • Confidentiality and data integrity
  • Audit, legal aspects, regulatory process and DSMB at icddr,b and Bangladesh
  • Supply and handling of the investigational product(s)

 

Training modality

The training will be conducted online via Zoom platform. Participants will need to have a computer with high speed internet connection. Participants are requested to install Zoom and Microsoft Office Suite into their computer on their own.
 

Training facilitation

Resource persons are from icddr,b and from outsides who have long experience will facilitate this course.

 

Target participants and participants’ selection

Staff members from the scientific track of icddr,b  at GS4 to NOB level involved in clinical training/research.  However, preference will be given to current/past PI’s involved in clinical research at different levels; researchers who don’t have GCP certification yet or certificate received more than two years ago, but intend to involve in clinical research and female applicants.

 

Course duration and timing

The course will be conducted for 3 days. Sessions will be conducted from 0830 to 1700 hours. But at times it may continue beyond this.

 

Course fee and course fee submission procedure

USD 225 (Two Hundred and Twenty Five Dollar) to be supported by SIDA through Research Administration (RA), icddr,b. The course fee includes tuition fee, training materials and certificate of participation. During application, all applicants should use the budget code 27214322. Upon acceptance, applicant will receive an email with a memorandum. Applicant should FORWARD the mail to his/her supervisor to obtain email approval. There is no need to edit or sign the memorandum. Only written 'Approved' in the mail body will suffice. The approval mail with the memorandum should be forwarded to rahat@icddrb.org. Once the whole process is complete, the participant will receive an email of enrollment confirmation. 

 

Registration and application

All interested participants must apply for registration through online.

 

Certification

Each participant will be awarded with a certificate only after successful completion of the course. As per the decision of SLT, no certificate will be issued without 100% participation.

 

 Last date of application: 10 August 2020

 

For further information, please contact:

Dr. Shakila Banu

Training Physician

Technical Training Unit

Email: shakila@icddrb.org 

 

For submission of course fee using memorandum, please contact:

Mohammad Asaduzzaman

Admin Assistant

Technical Training Unit

E-mail: mohammad.asaduzzaman@icddrb.org

Mobile: +880175 562 8427