UW Human Subjects Protections Course (Basic Course)

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)

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UW Human Subjects Protections Course (Refresher Course)

Required Modules (learner must complete all)

  • Investigator Responsibilities (ID: 16391)

  • Biomed Refresher 1 – Populations in Research Requiring Additional Considerations and/or Protections (ID: 985)

  • SBE Refresher 1 – History and Ethical Principles (ID: 936)

  • SBE Refresher 2 – Assessing Risk (ID: 12624)

  • Biomed Refresher 1 – Informed Consent (ID: 980)

  • University of Wisconsin – Madison (ID: 12133)

Elective Modules (learner must complete at least 2)

  • International Research – SBE (ID: 509)

  • Biomed Refresher 2 – Genetics Research (ID: 518)

  • Biomed Refresher 2 – FDA-Regulated Research (ID: 524)

  • Recognizing and Reporting Unanticipated Problems Involving Risks to Subjects or Others in Biomedical Research (ID: 14777)

  • Unanticipated Problems and Reporting Requirements in Social and Behavioral Research (ID: 14928)

  • UW-Madison Human Subjects Research Infrastructure (ID: 16392)

  • Introduction To Community-Engaged Research (CEnR) (ID: 16994)

  • Introduction to Community-Based Participatory Research (CBPR) (ID: 16995)

  • Biomed Refresher 1 – Research Involving Children (ID: 974)

  • SBE Refresher 1 – Research in Educational Settings (ID: 940)

  • SBE Refresher 2 – Privacy and Confidentiality (ID: 12622)

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Good Clinical Practice for Drug/Device Researchers (Basic Course)

  • 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)

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Good Clinical Practice for Drug/Device Researchers (Refresher Course)

  • International Council for Harmonisation (ICH): GCP Requirements (ID: 21995)

  • Sponsor Responsibilities and GCP (ID: 22001)

  • Investigator’s Responsibilities and GCP (ID: 21996)

  • Informed Consent (ID: 21997)

  • Conducting Clinical Investigations of Devices (ID: 17205)

  • Review of U.S. FDA Regulations for Investigational Devices (ID: 17206)

  • Informed Consent and Exceptions to the Requirement for Obtaining Consent for Clinical Investigations of Devices (ID: 17208)

  • Oversight of Clinical Investigations of Devices (ID: 17209)

  • Reporting Requirements for Clinical Investigations of Devices (ID: 17210)

  • Additional GCP Standards for International Clinical Investigations of Devices (ID: 17207)

  • Investigational Product (Drug) Management (ID: 21999)

  • Safety Management (ID: 21998)

  • Audits, Inspection, and Monitoring of Research Studies (ID: 22000)

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GCP – Social and Behavioral Research Best Practices for Clinical Research (Basic Course)

  • 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)

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GCP – Social and Behavioral Research Best Practices for Clinical Research (Refresher Course)

Required Modules

  • When a Social and Behavioral Research Study May be Considered a Clinical Trial (ID: 17652)

  • Overview of ICH E6 GCP for Behavioral Interventions and Social Science Research (ID: 17653)

  • Investigator’s Role and Responsibilities in Behavioral Interventions and Social Science Research (ID: 17654)

  • Informed Consent in Behavioral Interventions and Social Science Research (ID: 17655)

  • Monitoring, Audits, Inspections, and Data and Safety Monitoring of Behavioral Interventions and Social Science Research (ID: 17656)

  • In-Depth Review of ICH E6 and TransCelerate Minimum Requirements (ID: 17659)

Supplemental Modules

  • Methods and Risks in Behavioral Interventions and Social Science Research (ID: 17657)

  • Social Media in Behavioral Interventions and Social Science Research (ID: 17658)

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