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Human Subjects Protections Modules
Required Modules (learner must complete all)
- Populations in Research Requiring Additional Considerations and/or Protections (ID:
16680) - History and Ethical Principles – SBE (ID: 490)
- Defining Research with Human Subjects – SBE (ID: 491)
- Assessing Risk – SBE (ID: 503)
- Informed Consent – SBE (ID: 504)
- Investigator Responsibilities – EDSBS (ID: 16391)
- UW-Madison Human Subjects Research Infrastructure (ID: 16392)
- University of Wisconsin – Madison (ID: 12133)
Elective Modules (learner must complete at least 2)
- Research with Children – SBE (ID: 507)
- Research in Public Elementary and Secondary Schools – SBE (ID: 508)
- Consent and Subject Recruitment Challenges: Therapeutic Misconception (ID: 17259)
- Consent with Subjects Who Do Not Speak English (ID: 17260)
- Research with Decisionally Impaired Subjects (ID: 16610)
Good Clinical Practice Modules by Course
Good Clinical Practice for Drug/Device Researchers:
- The CITI Good Clinical Practice Course for Clinical Trials Involving Drugs and Devices (ID: 1350)
- Overview of New Drug Development (ID: 1351)
- Overview of ICH GCP (ID: 1352)
- ICH – Comparison Between ICH GCP E6 and U.S. FDA Regulations (ID: 1354)
- Conducting Investigator-Initiated Studies According to FDA Regulations and GCP (ID: 1355)
- Investigator Obligations in FDA-Regulated Research (ID: 1356)
- Managing Investigational Agents According to GCP Requirements (ID: 1357)
- Overview of U.S. FDA Regulations for Medical Devices (ID: 1358)
- Informed Consent in Clinical Trials of Drugs, Biologics, and Devices (ID: 1359)
- Detecting and Evaluating Adverse Events (ID: 1360)
- Reporting Serious Adverse Events (ID: 1361)
- Audits and Inspections of Clinical Trials (ID: 1363)
- Monitoring of Clinical Trials by Industry Sponsors (ID: 1362)
- Completing the CITI GCP Course (ID: 1364)
GCP – Social and Behavioral Research Best Practices for Clinical Research:
- Introduction (ID: 17531)
- Research Protocol (ID: 17532)
- Recruitment and Retention (ID: 17533)
- Informed Consent Communication (ID: 17534)
- Privacy and Confidentiality (ID: 17535)
- Participant Safety and Adverse Event Reporting (ID: 17536)
- Quality Control and Assurance (ID: 17537)
- Research Misconduct (ID: 17538)
- Conclusion (ID: 17539)