Research Ethics, Participant Protection and Good Clinical Practice Principles
Distinguish research governance requirements.
What you will learn
- Distinguish research governance requirements.
- Explain voluntary informed participation.
- Assess risks fairness and vulnerability.
- Protect data and biological materials.
- Describe GCP roles and reliable records.
- Manage amendments safety concerns and reporting.
Course content
6 lessons + final assessmentSelect a lesson to view its details.
01Approval before activityNot started
O1
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02Consent as a processNot started
O2
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03Risk benefit and fairnessNot started
O3
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04Data and samplesNot started
O4
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05GCP principles and responsibilitiesNot started
O5
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06Changes safety and integrityNot started
O6
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18 questions · 30 minutes · Pass: 15 correct
Who this course is for
Assessed introductory knowledge of research ethics and GCP principles.
Prerequisite: Course 37 recommended.
Scope and professional boundaries
Assessed introductory knowledge of research ethics and GCP principles. This is not automatically an employer-accepted GCP qualification, NHRA research-assistant training, ethics approval or authority to conduct a trial.
References
- Zambia NHRA Authority to conduct research ↗
- UK HRA What approvals and decisions do I need ↗
- NHRA Frequently Asked Questions ↗
- Medicines and Allied Substances Act No 3 of 2013 Zambia ↗
- WMA Declaration of Helsinki 2024 ↗
- ICH E6 R3 consolidated guideline June 2026 including Annex 2 ↗
- OHRP Withdrawal of Subjects from Research Guidance 2010 ↗
- AIUM Prudent clinical use and safety of diagnostic ultrasound revised May 2024 ↗
- DICOM PS3.15 2026d Attribute confidentiality profiles E.2 ↗
- DICOM PS3.15 2026d Clean Pixel Data Option E.3.1 ↗
- NHRA Guidelines for Transfer of Biological Materials for Research and Quality Assurance Purposes in Zambia August 2019 ↗
- EMA ICH E6 good clinical practice implementation dates ↗
