For Researchers
This page provides investigators and personnel involved in human subjects research links to key guidance and resources for conducting research, from study initiation to study closure.
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
ED/SBS IRB
Getting Started
HS/MR IRB
Information for New Investigators
Protocol Development
HS/MR IRB
Protocol Guidance
Other Links
ICTR Clinical Research Toolkit ("Before You Begin a Study" tab)
ICTR Protocol Development Office
Informed Consent Development
ED/SBS IRB
Informed Consent Guidance
Research with Minors Guidance
HS/MR IRB
Informed Consent Guidance
Informed Consent Templates
Informed Consent Model Language Samples
Vulnerable Populations Guidance
Other Links
Informed Consent Requirements (video)
Effective Consent Forms and the Process (video)
Strategies for Improving the Process (video)
OHRP: General Informed Consent Requirements (video)
Informed Consent Wizard
Combined Consent HIPAA Wizard
ICTR Clinical Research Toolkit (Before You Begin a Study tab)
Research with Vulnerable and Underrepresented Populations (panel discussion)
IRB Submission
ED/SBS IRB
Initial Review Application Help
Top Ten Tips
Checklist to Avoid Delays
HS/MR IRB
ARROW Initial Review Help
Protocol Guidance
Application Type Guidance
Other Links
Practical Regulatory Issues in Human Subjects Research (video)
The next step is conducting the study as approved, periodically re-assessing and making changes when needed.
Screening and Recruitment
ED/SBS IRB
IRB Guidance: Qualitative Research
HS/MR IRB
Subject Recruitment and Screening Procedures
Other Links
Recruitment and Retention of Research Participants (panel discussion)
Data Sharing
ED/SBS IRB
IRB Guidance: Data Release Agreements
HS/MR IRB
Sending or Receiving Specimens/Data/Images Guidance
Decision Tree for Sharing Data, Samples, or Images with Non-UW Site
ClinicalTrials.gov
HS/MR IRB
Requirements for Registering with Clinicaltrials.gov
Other Links
Support for Clinical Trials Registration & Results Reporting
Reportable Events
ED/SBS IRB
Reportable Event Guidance
HS/MR IRB
Reportable Event Guidance
Other Links
Preventing Noncompliance
Investigating the Cause of Noncompliance and Implementing Corrective and Preventive Action (CAPA) Plans
Changes of Protocol
ED/SBS IRB
Application
Process
Review Types & Timing
HS/MR IRB
Guidance on Presenting Changes of Protocol to IRB
Expedited Change of Protocol Guidance
Personnel Change Guidance
Continuing Review
ED/SBS IRB
Application
Process
Review Types & Timing
HS/MR IRB
UW-Madison Purview Enrollment Guidance
Self-Assessment
Other Links
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
Other Links
Post-Approval Monitoring Program
The final step is initiating the IRB closure process and ensuring proper retention of study records.
Study Closure & Data Retention
ED/SBS IRB
Post Project Procedures & Data Retention Guidance
End of a Study Guidance
HS/MR IRB
Protocol Closure Guidance
How to Close Studies
Other Links
Campus Policy on Data Stewardship, Access, and Retention
Lab Close-Out Checklist
UW Archives and Record Management