Develop Study Design

Find resources to help you design your study.

Research protocol templates

The HRPP Toolkit Library is where the Institutional Review Board (IRB) provides the following research protocol templates and other useful templates:

Study start-up guidance

CTSI Research Preparation Group (RPG)
The RPG Clinical Research Specialists support researchers in each phase of the start-up process; study planning and study activation.

Data management planning resources

Data management plan (DMP)
University of Minnesota Libraries provides information, tools, and direct support consultations, including utilizing the Data Repository for the University of Minnesota (DRUM).

This online application can help you create a data management plans that meets institutional and funder requirements. Log in with your x.500 to save your plans and get University-specific resources.

Dataverse Project
Data management plan best practices, templates, and background information.

Participant Recruitment Planning

CTSI's Recruitment Center
The Clinical and Translational Science Institute's (CTSI) Recruitment Center offers consultations, guidance, strategic plans, and tools to help attract participants -- all at no charge to University researchers.

Additional study design resources

The Biostats4you website provides statistical resources for non-statisticians. The site contains  biostatistical training materials suited for non-statistician medical and public health researchers, including topics such as sample size calculators, hypothesis tests, and power analysis methods. 

Community-Centered Dissemination Toolkit
The Community-Centered Dissemination Toolkit is a resource designed to help research teams incorporate community-engagement principles into dissemination planning.

Improve Diversity in Clinical Research
Resources to create an equitable clinical research environment from the Multi-Regional Clinical Trial (MRCT) of Brigham and Women’s Hospital and Harvard University. Includes the Achieving Diversity, Inclusion, and Equity in Clinical Research Guidance Document.

NIH Division of Human Subjects Research (DHSR) Resources on Human Subjects, Clinical Trials, and Inclusion
A one-page resource to help you find the information you need as you develop your human participants grant application. In this tool you’ll find useful tips like how to use the participant-level data template, an infographic on exempt human subjects research, and a decision tool to determine if your study is considered a clinical trial.

Patient-Centered Outcomes Research Institute (PCORI) Methodology Report
Provides methodology standards for patient-centered outcomes research.

Project Management for Research
The Ohio State University website makes a variety of tools available for managing research projects, including recommendations for general project management software and toolkits to help you and your team manage activities from grant writing to implementation and project closeout.

Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Statement
Protocol design recommendations, and a 33-item checklist of scientific, ethical, and administrative elements to include in a clinical trial protocol.

University Survey and Assessment Services (USAS)
Specializes in providing survey research, evaluation, and assessment services. Uses a variety of ways to contact participants and collect data, from longitudinal, to multi-mode projects, including online, mail, focus groups, and paper surveys.

World Health Organization (WHO) recommended format for a Research Protocol


For questions or to schedule a consultation:

CTSI Research Navigator