Curriculum
- 7 Sections
- 20 Topics
- 16 Weeks
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- Section 1: Human Research Ethics Overview4
- 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 Groups2
- Section 4: Risk and Benefit Assessment4
- Section 5: Privacy and Confidentiality8
- 5.1Privacy and confidentiality
- 5.2Quiz: Privacy and confidentiality2 Questions
- 5.3PDPA related to medical research
- 5.4Quiz: PDPA related to medical research2 Questions
- 5.5Laws and regulations related to research
- 5.6Quiz: Laws and regulations related to research2 Questions
- 5.7Data sharing and material transfer agreement
- 5.8Quiz: Data sharing and material transfer agreement2 Questions
- Section 6: Reporting4
- Section 7: Good Clinical Practice (GCP)14
- 7.1Overview of International Council for Harmonisation (ICH)
- 7.2Quiz: Overview of International Council for Harmonisation (ICH)2 Questions
- 7.3Sponsor responsibilities / Sponsor obligations in FDA-regulated research
- 7.4Quiz: Sponsor responsibilities / Sponsor obligations in FDA-regulated research2 Questions
- 7.5Audits, inspection, and monitoring of research studies
- 7.6Quiz: Audits, inspection, and monitoring of research studies2 Questions
- 7.7Investigator’s responsibilities
- 7.8Quiz: Investigator’s responsibilities2 Questions
- 7.9Data governance
- 7.10Quiz: Data governance2 Questions
- 7.11Essential documents
- 7.12Quiz: Essential documents2 Questions
- 7.13Managing investigational agents according to GCP requirements
- 7.14Quiz: Managing investigational agents according to GCP requirements2 Questions