Welcome to the RaPD Resource Library. Below are key resources that we hope will be helpful to you in planning your study. Please reach out if you are looking for any resources not included here.
Templates
ICTR protocol templates: ICTR created several protocol templates, an interventional template and an observational template. Each provides example text to help guide you. We recommend writing N/A in sections that do not apply to you instead of deleting the section and altering the subsequent section numbering.
UW IRB templates: The UW IRB provides templates as well, including a protocol template for registries and repositories and consent and authorization templates.
Recruitment email template: ICTR created this template for recruiting participants by email.
Regulatory
For new projects, start by figuring out what level of IRB review is needed – more information at the IRB new study page and the “different types of research” page and summary provided below:
Non-protocol based application (nPBA): Use this application type for most minimal risk research.
Protocol-based application: This application type is required for more than minimal risk studies, including most clinical trials.
Exemption application: Certain types of studies may be exempt from IRB review. However, you must still submit an exemption application to the IRB “since only the IRB can determine whether the research is exempt from review.”
Multi-site studies: For multi-site studies, contact the UW RELIANT team and review the Reliance Manual.
Quality improvement or program evaluation: “Projects that do not meet the federal definition of research pursuant to 45 CFR 46 do not require IRB review.” You can assess whether your project qualifies as QI or program evaluation here: IRB QI/Program Evaluation Self-Certification Tool. Save a copy of the PDF created by the tool for your records.
Research Registries and Repositories: See IRB guidance and template.
Other kinds of research (including biospecimen and decedent research): More information on these application types is available here
Not research/not human subjects research: See this IRB page for more information.
UW Health/SMPH Research Operations Committee (UROC): UROC reviews the feasibility of proposed studies. View the decision tree to see if you need UROC review.
Scientific Review Committee (SRC): The SRC assesses the scientific merit of investigator-initiated, non-oncology research that has not already undergone peer review. This guidance can help you decide whether SRC review is required.
ClinicalTrials.gov: The UW ClinicalTrials.gov Service has information on what kinds of studies need to register on CT.gov and is available to help you with your registration and questions.
OnCore: “OnCore is a centralized Clinical Trial Management System (CTMS) that allows researchers to use one program to manage various components of clinical research while maintaining consistency and compliance across the institution.” Visit the OnCore Usage Decision Tree to see whether your study needs to be in OnCore.
Data Monitoring Committee (DMC): The DMC helps investigators ensure subject safety, research integrity, and compliance with federal regulations and local policies. Use this guide to determine whether your study needs to use the DMC.
FDA resource: Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD). This site includes templates, educational videos and FAQs about drug and device research.
Guidance for Assessing and Monitoring Adverse Events in Behavioral Clinical Trials: This guidance document provides preparation and guidance for all research personnel to fulfill their role in the safety monitoring required by the UW-Madison Health Institutional Review Board (IRB).
Programs and Services
Biomedical Data Science Program: Complete this request form for statistical support, including from the Biostatistics and Epidemiology Research and Design Core.
SMPH Recruitment Core: “The Recruitment Core’s mission is to utilize data and technology to optimize clinical research recruitment efforts at UW–Madison using the following services.” Contact them about candidate recruitment lists, MyChart recruitment invitations and more.
Wisconsin Network for Research Support (WINRS): WINRS provides consultation on community-engagement strategies and connection to community advisors via standing community advisory groups.
Training and Education
Human Subjects Protections Training: Information on required and optional training including CITI, Good Clinical Practice and HIPAA Privacy and Research Training.
IRB and ARROW trainings: Includes IRB for Beginners, ARROW and reliance training.
UW Professional Research Education Program (PREP): Register for upcoming courses or view recordings of past training on consent, recruitment, IRB, study coordination, and more.
UW Clinical Trials Community of Practice recordings: Watch recorded sessions on a variety of topics including pragmatic trials, multi-site study management, reportable events and more.
UW REDCap training: Links to self-enrolling Canvas courses on basic REDCap setup, project design, user rights training and more.
ICTR Scientific Editing writing training: Recordings, slides and resources on writing grant documents, manuscripts and conference materials. Recording, slides and resources from a 2022 workshop on Fundamentals of Protocol Writing are also available.
Data Management 101 training: Online, self-paced training created by UW Research Data Services.
Funding Opportunities
Other Resources
UW medRISE Grants Library Repository (GLR): The GLR “…is a collection of successfully funded proposals of various types and sponsors. Access to the GLR is available to UW-Madison faculty, investigators, and designated staff with a NetID.” Request access here.
UW Research Cores Directory: Online lookup to find cores (labs, centers, offices, units), resources (equipment, space, software, datasets, etc.) and services (analysis, consulting, training, etc.) The Researcher Toolkit Resource List may also be helpful.
Research and Business Bridging Intelligence Tool (RABBIT): Search University of Wisconsin-Madison faculty and researchers to find potential collaborators and synergies.
UW-Madison Data Storage Finder: UW Research Data Services made this interactive tool to help you rapidly identify options for research data storage.
Data Management and Sharing Plans: UW Research Data Services can assist and advise whether you can use DMPTool, “…which is a free, open-source, online tool that helps researchers structure and draft data management and sharing plans as well as share their plans with others.”