An Introduction to Good Clinical Practices (cGCP) – Part 1
Description:
Good Clinical Practice (GCP) is an international ethical and scientific quality standard provided by International Council for Harmonisation (ICH) for the design, conduct, performance, monitoring, auditing, recording, analyzes and reporting of clinical trials that involve the participation of human subjects. 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.
Curriculum for this course:
Introduction
| Overview | 1 min 10 secs |
| Learning Objectives | 54 secs |
| Who Should Take This Course? | 1 min 04 secs |
| Course Modules | 1 min 30 secs |
Module 1: Overview
| What is GCP? | 1 min 10 secs |
| History of Ethical Guidelines | 1 min 05 secs |
| The Nuremberg Code | 45 secs |
| Declaration of Helsinki | 50 secs |
| The Belmont Report | 1 min 20 secs |
| International Guidelines for Biomedical Research Involving Human Subjects | 1 min 07 secs |
| The Principles of ICH-GCP – Part 1 | 1 min 34 secs |
| The Principles of ICH-GCP – Part 2 | 1 min 42 secs |
| Knowledge Check | 1 min |
Module 2: Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs)
| What is the IRB/IEC | 1 min 20 secs |
| Composition of the IRB/IEC | 1 min 10 secs |
| Major Responsibilities of the IRB/IEC | 1 min 32 secs |
| Working Procedures | 1 min 17 secs |
| Maintenance of Records | 1 min 46 secs |
| Knowledge Check | 1 min |
Module 3: An Overview of Investigators Responsibilities
| Who Can Be an Investigator? | 1 min 07 secs |
| Responsibilities: Resourcing | 1 min 18 secs |
| Responsibilities: Medical Care of Trial Subjects | 1 min 29 secs |
| Responsibilities: Ethical Approval | 1 min 36 secs |
| Responsibilities: Compliance with Protocol | 1 min 42 secs |
| Responsibilities: Investigational Medicinal Products (IMP) | 58 secs |
| Responsibilities: Randomization | 1 min 50 secs |
| Responsibilities: Records and Reports | 51 secs |
| Responsibilities: Safety Reporting | 1 min 25 secs |
| Responsibilities: General Responsibilities | 1 min 31 secs |
| Knowledge Check | 1 min |
Module 4: Informed Consent
| Informed Consent and its Importance | 1 min 21 secs |
| Informed Consent Process | 1 min 35 secs |
| Informed Consent Form | 1 min 17 secs |
| Revisions to Informed Consent | 1 min 52 secs |
| Knowledge Check | 1 min |
Conclusion
Final Assessment
Certification
Revision History
| Course updated to v2.0 on 3/22/2023 to fix assessment functionality and rearrange course content | Version 2.0 |
| Course updated to v2.1 on 4/5/2023 for minor text change | Version 2.1 |
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-901 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes -
version: 2.1 -
Effective Date: 05/04/2023
Reviews:
A perfect introduction to the world of Good Clinical Practices.
Love this style of learning, the informed consent section was very useful to me.
A must do course for anyone entering the field of clinical trials.
We’ve incorporated this course into our induction training for new hires.
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How to Manage Deviations in a GMP Environment – Part 2
Corrective and Preventive Actions (CAPA)
Laboratory Investigations & Deviations
How to Write Effective Standard Operating Procedures (SOPs)
How to be an Effective GMP Auditor – Part 1
Good Manufacturing Practices (cGMP)
Risk Based Equipment Qualification
Sources of Contamination in a GMP Environment
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