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
Author:
General Info:
-
CEU Credits: 0.1 -
Course code: ELM-902 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
An excellent introduction to the world of GCP and how the whole process works.
Loved the Sponsors Responsibility section clear concise and to the point. We are now rolling this training out as a mandatory course.
Related courses:
An Introduction to Good Clinical Practices (cGCP) – Part 1
Good Laboratory Practices: History and Regulatory Compliance
Private: An Introduction to Good Manufacturing Practices (cGMP)
Combination Products (Drugs, Devices and Biologics) – Part 1
Contamination Control Strategies in a GMP Environment
Data Integrity Awareness: ALCOA+
Data Integrity Awareness: Good Documentation Practices
Talk to us
Find out how we can help you bring your life science training to the next level.