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
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
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
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
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