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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
Investigator and Reliance Manuals

Protocol Development

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

Informed Consent Development

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

IRB Submission

Investigator Manual
ARROW Guidance

Other Links

Professional Research Education Program (PREP) training videos

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

Screening and Recruitment

Investigator Manual
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)
Remote Consent 101 (video)

Data Sharing

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

ClinicalTrials.gov

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

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

Investigator Manual
Expedited Change of Protocol Guidance
Personnel Change Guidance

Continuing Review

UW-Madison Purview Enrollment Guidance

Self-Assessment

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

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