Multisite Research Support Service

Reliance and Navigation Team (RELIANT)

The HRPP Reliance and Navigation Team (RELIANT) assists researchers with collaborative research issues, including single IRB review, ceding IRB review, and working with external personnel. They facilitate the process for executing reliance agreements when needed as well as supporting researchers working with a commercial IRB or the NCI CIRB. Collaborative research issues and reliance arrangements can be complex, so we encourage you to consult with us (irbreliance@wisc.edu) early in your grant preparation and/or study design process.

UW’s IRB Reliance Manual

Visit UW-Madison’s Reliance Manual, designed to guide you through policies and procedures related to human research overseen by the institution’s IRBs when it serves as the reviewing IRB for external individuals or institutions. This manual also provides guidance on when the institution relies on an external IRB. 

SIRB Training: Lead Study Team Education Module

A detailed slide presentation that provides step‑by‑step guidance for lead study teams serving as the single IRB (sIRB) of record for multicenter research. Intended Audience: Lead study teams, coordinating center staff, and research administrators responsible for managing or supporting single IRB (sIRB) review for multicenter studies. A recording of this presentation is also included.

SIRB Training: Relying Site HRP Education Module

A detailed slide presentation offering step‑by‑step guidance for relying study teams involved in multicenter research using a single IRB (sIRB) model. Intended Audience: Relying site investigators, study coordinators, and regulatory staff involved in sIRB site onboarding and approval for multicenter studies. A recording of this presentation is also included.

SMART IRB is a platform designed to ease common challenges associated with initiating multisite research and to provide a roadmap for institutions to implement the NIH Single IRB Review policy (effective date: January 25, 2018). Freely available for institutions and investigators, SMART IRB is an integrated, comprehensive platform that allows flexibility in the size and scope of collaboration to enable IRB reliance for multisite studies across the nation, regardless of funding status.

You can find the following on the SMART IRB Website:

• SMART IRB Agreement to streamline IRB review
• Online Reliance System for your studies
• SOPs, Templates, and Checklists
• Access to Expertise across the Nation

IRB Reliance Exchange (IREx)

IREx is a freely available, web-based portal supporting single IRB review documentation and coordination for multi-center clinical trials. IREx supports reviewing IRBs and Lead Study Teams/Coordinating Centers in tracking cede decisions and agreements completion; capturing site-specific local considerations and sIRB approvals for relying sites; and coordinating site readiness for sIRB review, facilitating submissions, and sharing approvals.

See TIN’s IREx Workflow and sIRB Lessons Learned, IREx’s Introducing Single IRB Review video, and IREx Overview for Lead Study Teams/Coordinating Centers for helpful tips.

Manual of Procedure (MOP) Templates

• NIA Multisite MOP Template
• NIAMS Multisite MOP Template

Site Initiation Visit (SIV) Template

Project Management Plan

This document provides an adaptable project management structure to support the overall management of clinical research studies throughout the study’s life cycle.

You can also find downloadable project management template tools below:

• Project Tracker Template
• Free Project Management Plan Templates
• Free Timeline Templates for Google Sheets, Docs, and Slides

Multisite Roles and Responsibilities Table 

This document outlines the responsibilities of a Program or Project Manager versus a Research Coordinator on a multisite trial.

Communication Plan Template

This document outlines the communication and escalation pathways between members of a Project Team to improve the efficiency of the implementation of the trial. It should be tailored to meet the specific needs of a given project.

RACI Matrix

The RACI Matrix is a tool that can be used to help identify roles and responsibilities and to set expectations early on in a project. This template is adapted for study teams at Clinical Coordinating/Data Coordinating Centers, but can be modified for broader use.

A Guide to Managing a Trial Master File

This 7-minute, interactive eLearning module provides a brief, high-level overview of how to manage a Trial Master File (TMF), specifically from the perspective of an Academic Research Organization (Utah DCC). Learning objectives include: 1. Explain the function, importance, and components of a TMF 2. Create a list of Essential Documents needed for a study 3. Recognize how monitoring of essential documents relates to the risk-based monitoring plan.

Risk-Based Monitoring Plan

A risk-based monitoring plan (RBMP) is a document that outlines the strategy, activities, responsibilities, and requirements for monitoring a study. It is customized to the specific study and focuses monitoring efforts on mitigating significant and likely risks to data and processes critical to participant protection and trial integrity.

Investigator Regulatory Binder Sections & Table of Contents Template

Guide / template for organizing the investigator binder that contains essential site level clinical trial regulatory documents.

Multisite Feasibility Assessment Survey 

This form is designed to support site feasibility assessment and may be distributed to prospective sites for completion. Please tailor the survey to align with the specific needs of the study by modifying or removing questions as appropriate.

Trial Innovation Network (TIN)

The Trial Innovation Network (TIN) supports site selection for multisite clinical trials by leveraging its national network and local expertise to identify well‑matched, high‑performing sites. Investigators seeking assistance with site selection are encouraged to contact the Multisite Research Support Service for assistance.

Mastering Multi-Site Clinical Trials: Strategies, Challenges, and Best Practices

Ali Moellner, MPH and Theresa Lins, MS, PMP, ICTR’s Multi-Site Project Managers presented on best practices for planning and managing successful multisite clinical trials, from budgeting to communication strategies.

The Multi-Site Manifesto: A PI’s Field Guide to High-Impact Collaborative Research

Adam Gepner, MD, associate professor of Cardiovascular Medicine at UW–Madison shared “The Multi-Site Manifesto”—a practical roadmap for PIs looking to expand their research footprint. Whether you are currently planning a multi-center study or looking to optimize an existing network, this seminar offers real-world lessons on managing the complexity of distributed clinical research.

Clinical Trial Budgeting: What Every PI Should Know

UW’s Data Coordinating Center

The DCC supports investigator-initiated NIH or industry-sponsored randomized controlled trials (RCTs) by providing expertise in statistical methodology and support for data management, quality control and assurance, study monitoring and communications using clinical trials data management system and other information systems. Contact Kelly Miller with questions: kamiller@biostat.wisc.edu

ICTR Data Monitoring Committee

The DMC helps investigators ensure subject safety, research integrity, and compliance with federal regulations and local policies. The DMC also makes recommendations to the PI that could include actions of continuation, modification, suspension, or termination.

Clinical Trial Institute (CTI) Central Monitoring Service

UW Principal Investigators may contract with the CMS to monitor the progress of FDA-regulated, investigator-initiated clinical trials, and verify that the study is conducted, recorded, and reported in accordance with the protocol, standard operating procedures, and applicable regulatory requirements.