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
ClinicalTrials.gov
Clinicaltrials.gov Requirements
Support for Clinical Trials Registration & Results Reporting
Introduction to the new ClinicalTrials.gov 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
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
How to Submit
Campus Policy on Data Stewardship, Access, and Retention
Lab Close-Out Checklist
UW Archives and Record Management