Human Subjects Protections Course 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)
  • Introduction To Community-Engaged Research (CEnR) (ID: 16994)
  • Introduction to Community-Based Participatory Research (CBPR) (ID: 16995)
  • 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)