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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, including funding agency and data management guidelines.

DMPTool
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.

Additional study design resources

Biostats4you
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. 

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

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.

Contact

For questions or to schedule a consultation:

CTSI Research Navigator