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University of Wisconsin–Madison

Education and Training

Download and read the overview of Human Subjects Research Infrastructure (PDF), which provides a description of the various components of research infrastructure at the University of Wisconsin–Madison. Use it as a guide to help determine which training, compliance, and oversight mechanisms at UW apply to your research.

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Training Matrix

Required Training: The training matrix below describes some of the minimum training requirements to conduct human subjects research at the University of Wisconsin-Madison. Follow the links provided for information about the specific trainings. Note: Depending on the type of research being conducted, there may be other applicable training requirements. Please review the Research Infrastructure presentation above to see how your research may trigger additional training requirements.

Training requirements for investigators and research staff
  Investigators Research Staff that interact with subjects Research Staff that do not interact with subjects
Human Subjects Protections training YES YES YES
Good Clinical Practice training YES (if FDA-regulated*) YES (if FDA-regulated*) NO
HIPAA Privacy and Research training Check HIPAA Link Check HIPAA Link Check HIPAA Link

*Human Subjects Training Snapshot in ARROW will indicate when Good Clinical Practice training is required.
Current training can be checked via the VCRGE Research Certification Look-Up or the PI Portal.

Optional Training: The table below is a collection of general trainings that touch on many aspects of the human subjects research process. Target audience is merely suggestive.

Target audience key: A = FDA regulated research; B = Non-FDA regulated biomedical research; C = Education/Social/Behavioral Research

Optional training
Target Audience Link Description
A, B Basics of Conducting Clinical Research at UW Health This course builds off of HSP and GCP courses provided through CITI. Though it was developed specifically to address clinical research within the UW health environment, most content is applicable to all clinical research.
A, B, C Office of Research Integrity: The Research Clinic Interactive role-playing video. IRB Chair, PI, and Coordinator scenarios are appropriate for clinical researchers. Research assistant scenario is appropriate for social and behavioral researchers.

Additional Resources to Conduct High-Quality Research

High quality research starts with the proper training. The tables below present the most common resources, organized by the stage of the study and topic, that supplement the trainings listed above.

Pre-Study / Study Initiation

The first step is the development of a plan to conduct the research. In addition to the IRB application, this plan could include creation of  documents such as the protocol, the consent form(s), study data collection instruments, and instructions (e.g. standard operating procedures).

Additional learning resources
Topic Campus Policy ED/SBS IRB Guidance HS/MR IRB Guidance Other Links
Protocol Development     Protocol Guidance ICTR Clinical Research Toolkit (Before You Begin a Study tab)

ICTR Protocol Development Office
Informed Consent Development HRPP Policy on Obtaining and Documenting Informed Consent Informed Consent Guidance Informed Consent Guidance

Informed Consent Templates

Informed Consent Model Language Samples

Informed Consent Requirements  (video)

Effective Consent Forms and the Process (video)

Strategies for Improving the Process (video)

Informed Consent Wizard

Combined Consent HIPAA Wizard

ICTR Clinical Research Toolkit (Before You Begin a Study tab)
IRB Submission HRPP Policy on Initial Review: Submission and Review Policy  Initial Review Application Help

Top Ten Tips

Checklist to Avoid Delays
ARROW Initial Review Help

Protocol Guidance

Application Type Guidance
Practical Regulatory Issues in Human Subjects Research (video)
Research with Vulnerable Populations HRPP Policy on Research Involving Vulnerable Populations

HRPP Policy on Research with Adult Participants Lacking Capacity to Consent
Research with Minors Guidance Vulnerable Populations Guidance  Research with Vulnerable and Underrepresented Populations (panel discussion)
Data Storage and Data Sharing HRPP Policy on Protecting Research Participants Privacy Interests and Confidentiality of Data

Campus Policy on Data Stewardship, Access, and Retention
IRB Guidance: Data Release Agreements Sending or Receiving Specimens/Data/Images Guidance (decision tree)(PDF)  
ClinicalTrials.gov Support for Clinical Trials Registration & Results Reporting   Requirements for Registering with Clinicaltrials.gov

ClinicalTrials.gov Consent Form Language
 

Study Conduct

The next step is conducting the study as approved, periodically re-assessing and making changes when needed.

Study conduct resources
Topic Campus Policy ED/SBS IRB Guidance HS/MR Guidance Other Links
Informed Consent Process HRPP Policy on Obtaining and Documenting Informed Consent Informed Consent Guidance Informed Consent Guidance OHRP: General Informed Consent Requirements (video)

Effective Consent Forms and the Consent Process (video)

Screening and Recruitment   IRB Guidance: Qualitative Research Subject Recruitment and Screening Procedures Recruitment and Retention of Research Participants (panel discussion)
Reportable Events HRPP Policy on Noncompliance

HRPP Policy on Unanticipated Problems
Reportable Event Guidance Reportable Event Guidance Preventing Noncompliance

Investigating the Cause of Noncompliance and Implementing Corrective and Preventive Action (CAPA) Plans
Self-Assessment       Developing an Internal Quality Assurance (QA) Program Guidance

Post-Approval Monitoring Program Self-Assessment Tool (PDF)

ICTR Clinical Research Toolkit (Self-Assessment & Audit Prep tab)
Changes of Protocol Changes in Research Activities: Submission and Review Application

Process

Review Types & Timing
Guidance on Presenting Changes of Protocol to IRB

Expedited Change of Protocol Guidance

Personnel Change Guidance
 
Continuing Review Continuing Review: Submission and Review Application

Process

Review Types & Timing
UW-Madison Purview Enrollment Guidance  

Study Closure

The final step is initiating the IRB closure process and ensuring proper retention of study records.

IRB closure process
Topic Campus Policy ED/SBS IRB Guidance HS/MR Guidance Other Links
Study Closure  HRPP Policy on Study Closure Post Project Procedures & Data Retention Guidance

End of a Study Guidance
Protocol Closure Guidance

How to Close Studies
Lab Close-Out Checklist
Data Retention Campus Policy on Data Stewardship, Access, and Retention Post Project Procedures & Data Retention Guidance  Protocol Closure Guidance UW Archives and Record Management