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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

Investigator and Reliance Manuals
Professional Research Education Program (PREP) training videos

Protocol Development

Protocol Templates
ICTR Clinical Research Toolkit ("Before You Begin a Study" tab)

Informed Consent Development

Informed Consent Documents Guidance
Informed Consent Templates
Informed Consent Wizard
Working with Consent Documents
How to Write an Informed Consent Form (video)

IRB Submission

IRB Webpage - "How to Submit"
ARROW Guidance


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

Screening and Recruitment

Screening and Recruitment Guidance
Professional Research Education Program (PREP) training videos

Consent Process

Consent Processes and Documentation
HRP - 090 - SOP - Informed Consent Process for Research 
HRP - 091 -SOP - Written Documentation of Consent
Professional Research Education Program (PREP) training videos

Data Sharing

Sharing Specimens/Data/Images
Decision Tree for Sharing Data, Samples, or Images with Non-UW Site Requirements
Support for Clinical Trials Registration & Results Reporting
Introduction to the new Service Line (video)

Reportable Events

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

Changes of Protocol

Change of Protocol Guidance
Change of Protocol Submission Guidance

Continuing Review

Continuing Review 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

Professional Research Education Program (PREP) training videos


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

Study Closure & Data Retention

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