By the end of this course, you will be able to
An overview of the purpose, scope, and legal basis of GCP, and framework of principles that aim to ensure the safety of research participants and validity of data.
The key elements such as informed consent, investigational products handling, safety reporting, and trial-specific documentation, including data integrity key principles.
The principles of GCP, how they can be applied practically in the research setting, and learn why and how clinical trial activities are performed and documented.
Course details
- 1 h 42 m/19 lessons
- Last updated: 18/12/2019
- 9 Quiz
- 3 learning resources
- Course completion certificate
Course Content
Course Overview
Module 1: General Introduction
The Importance Of Clinical Trials
Course Overview
Module 1: General Introduction
The Importance Of Clinical Trials
Clinical Trial: The Process
Regulatory Authorities - MENA
International Council for Harmonisation (ICH)
Module 2: 13 ِEthical GCP Principles
Module 3: IRB & IEC
Module 4: Investigator's Responsibility
Randomization
Research Staff
Safety Report
Module 5: Sponsor Responsibility
Clinical Research Associate CRA
Module 7: Investigator's Brochure
Module 8: Essential Documents
Module 9: ICH GCP Updates
Module 10: Regulatory Inspection
Module 11: Investigator Initiated Trial
About this course
Conducting a successful clinical trial just got easier! This course is intended for professionals in all life science industries using human subjects in investigations, whether they're planning, conducting, monitoring, managing, analyzing, or otherwise supporting human clinical trials. This program is especially valuable for onboarding any employee involved directly or indirectly in clinical trial planning and execution to ensure alignment on GCP culture and fundamentals within your organization before engaging in work that impacts GCP compliance.
Course requirements and prerequisites
There are no requirements for this course. Your interest in the topic and your commitment to learning are all you need to achieve the utmost benefit from this course.
Mentor
Walaaeldin Ahmed
Medical Affairs And Clinical Research Manager
453 Learners
1 Course