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University of Wisconsin–Madison

For Researchers

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

Getting Started

Information for New Investigators

Protocol Development

Protocol Guidance
ICTR Clinical Research Toolkit ("Before You Begin a Study" tab)
ICTR Protocol Development Office

Informed Consent Development

Informed Consent Guidance
Informed Consent Templates
Informed Consent Wizard
Combined Consent HIPAA Wizard
Informed Consent Model Language Samples
Vulnerable Populations Guidance 
How to Write an Informed Consent Form (video)
Informed Consent Requirements  (video)
Effective Consent Forms and the Process (video)
OHRP: General Informed Consent Requirements (video)

IRB Submission

ARROW Initial Review Help
Protocol Guidance
Application Type Guidance

Other Links

Strategies for Improving the Process (video)
ICTR Clinical Research Toolkit (Before You Begin a Study tab)
Research with Vulnerable and Underrepresented Populations (panel discussion)
Practical Regulatory Issues in Human Subjects Research (video)
Study Initiation--Using the Clinical Research Infrastructure and Resources (video)
Single IRB Review (video)
HIPAA Implications in Research (video)
Developing Standard Operation Procedures (SOPs) (video)
Developing Data Collection Tools for Investigator-Initiated Clinical Trials (video)

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

Screening and Recruitment

Subject Recruitment and Screening Procedures
Recruitment and Retention of Research Participants (panel discussion)
Study Recruitment: What do "real people" recommend? (video)
Recruitment: Building Trust Between Minorities and Researchers (video)
Oneida Nation of Wisconsin and the Alzheimer's Disease Research Center: A Model of Engagement That Worked (video)
Research Recruitment Methods and Regulatory Considerations Across Study Populations (video)

Consent Process

HRPP Policy on Obtaining and Documenting Informed Consent
Informed Consent Guidance
How to Obtain Informed Consent (video)
Effective Consent Forms and the Consent Process (video)
Capacity to Consent Considerations in Research  (video)

Data Sharing

Sending or Receiving Specimens/Data/Images Guidance
Decision Tree for Sharing Data, Samples, or Images with Non-UW Site

Requirements for Registering with
Support for Clinical Trials Registration & Results Reporting
Introduction to the new Service Line

Reportable Events

Reportable Event Guidance
Preventing Noncompliance
Investigating the Cause of Noncompliance and Implementing Corrective and Preventive Action (CAPA) Plans
IRB Reportable Events and How to Prevent Them (video -- password Prep2020)
Identifying, Documenting, and Reporting (Serious) Adverse Events (video)

Changes of Protocol

Guidance on Presenting Changes of Protocol to IRB
Expedited Change of Protocol Guidance
Personnel Change Guidance
Changes of Protocol: IRB and Study Team Guidance (video--password Prep2020)

Continuing Review

UW-Madison Purview Enrollment Guidance


Developing an Internal Quality Assurance (QA) Program Guidance
Post-Approval Monitoring Program Self-Assessment Tool
ICTR Clinical Research Toolkit (Self-Assessment & Audit Prep tab)

Post-Approval Monitoring

Post-Approval Monitoring Program

Other Links

Internal Quality Assurance (QA) Procedures
Ensuring Patient Safety and Ethics in the Trenches


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

Study Closure & Data Retention

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