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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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