Curriculum
- 9 Sections
- 30 Topics
- 16 Weeks
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- Section 1: Human Research Ethics Overview8
- 1.1Research Involving Human Subjects
- 1.2Quiz: Research Involving Human Subjects2 Questions
- 1.3History and Ethics of Human Subjects Research
- 1.4Quiz: History and Ethics of Human Subjects Research2 Questions
- 1.5Institutional Review Board (IRB) Composition, responsibility and review process
- 1.6Quiz: Institutional Review Board (IRB) Composition, responsibility and review process2 Questions
- 1.7Types of protocol review
- 1.8Quiz: Types of protocol review2 Questions
- Section 2: Recruitment and Informed Consent Processes4
- 2.1Recruitment process, Informed consent process, Reconsent process, Informed opt-out
- 2.2Quiz: Recruitment process, Informed consent process, Reconsent process, Informed opt-out2 Questions
- 2.3Modifications and waivers of informed consent
- 2.4Quiz: Modifications and waivers of informed consent2 Questions
- Section 3: Research Involving Vulnerable Groups4
- Section 4: Risk and Benefit Assessment4
- Section 5: Research Integrity and Management2
- Section 6: Scientific and ethical considerations in different types of research12
- 6.1Biomedical science: Records-based research
- 6.2Quiz: Biomedical science: Records-based research2 Questions
- 6.3Biomedical science: Hospital-based research
- 6.4Quiz: Biomedical science: Hospital-based research2 Questions
- 6.5Community-based research
- 6.6Quiz: Community-based research2 Questions
- 6.7Laboratory-based research
- 6.8Quiz: Laboratory-based research2 Questions
- 6.9Human genetics
- 6.10Quiz: Human genetics2 Questions
- 6.11Biobank
- 6.12Quiz: Biobank2 Questions
- Section 7: Privacy and Confidentiality8
- 7.1Privacy and confidentiality
- 7.2Quiz: Privacy and confidentiality2 Questions
- 7.3PDPA related to medical research
- 7.4Quiz: PDPA related to medical research2 Questions
- 7.5Laws and regulations related to research
- 7.6Quiz: Laws and regulations related to research2 Questions
- 7.7Data sharing and material transfer agreement
- 7.8Quiz: Data sharing and material transfer agreement2 Questions
- Section 8: Reporting4
- Section 9: Good Clinical Practice (GCP)14
- 9.1Overview of International Council for Harmonisation (ICH)
- 9.2Quiz: Overview of International Council for Harmonisation (ICH)2 Questions
- 9.3Sponsor responsibilities / Sponsor obligations in FDA-regulated research
- 9.4Quiz: Sponsor responsibilities / Sponsor obligations in FDA-regulated research2 Questions
- 9.5Audits, inspection, and monitoring of research studies
- 9.6Quiz: Audits, inspection, and monitoring of research studies2 Questions
- 9.7Investigator’s responsibilities
- 9.8Quiz: Investigator’s responsibilities2 Questions
- 9.9Data governance
- 9.10Quiz: Data governance2 Questions
- 9.11Essential documents
- 9.12Quiz: Essential documents2 Questions
- 9.13Managing investigational agents according to GCP requirements
- 9.14Quiz: Managing investigational agents according to GCP requirements2 Questions