An Introduction to Good Clinical Practices (GCP) – Part 2

Description:

This course explores the relevance of Good Clinical Practices (GCP) in clinical research and trial programs. It covers clinical professional roles, clinical trial methodology, study design, protocol preparation, patient monitoring, quality assurance, ethical / legal issues and much more. Upon completion of this module, you will be able to know who a sponsor is, identify the roles and responsibilities of a sponsor and Understand the role of a Contract Research Organization (CRO)

Curriculum for this course:
Introduction
Overview 1 min 01 secs
Learning Objectives 58 secs
Who Should Take This Course? 1 min 11 secs
Course Modules 1 min 10 secs
Module 5: An Overview of the Sponsor’s Responsibilities
Who is a Sponsor 1 min 05 sec
Quality Assurance, Quality Control & Contract Research Organization (CRO) 1 min 10 secs
Medical Expertise and Trial Design 1 min 08 secs
Trial Management, Data Handling, and Record Keeping 1 min 17 secs
Information and Communication and Allocation of Responsibilities 1 min 07 secs
Investigator Selection 1 min 02 secs
Compensation and Financing 1 min 07 secs
Notification/Submission to Regulatory Authority 1 min 09 secs
Manufacturing, Packaging, Labelling, and Coding Investigational Product(s) 1 min 05 sec
General 1 min 14 secs
Module 6: Trial Monitoring
What is Trial Monitoring 1 min 01 secs
Selection and Qualities of a Good Monitor 56 secs
Monitoring Approach – Extent and Nature 1 min 02 secs
Types of Monitoring 1 min 25 secs
Roles and Responsibility of a Monitor 1 min 10 secs
Monitoring Report Structure 1 min 09 secs
Conclusion
Final Assessment
Certification
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