We provide expertise, guidance and education on development of a clinical or master protocol for investigator-initiated research.

Regulatory consultations are available to guide and support you as you design protocols and navigate through the scientific review process.

Services include:

• Education on protocol development
• Review and feedback on clinical or master protocols
• Guidance with Scientific Review Committee (SRC) review process
• Recommendation of suitable protocol template
• Facilitate referrals for statistical assistance

Links and guidance documents to help in developing a research protocol

• CTTI Recommendations: Quality by Design
• CTTI Principles of a Quality Protocol Document
• NIH-FDA Clinical Trials Protocol Template
• Protocol Template for Behavioral and Social Sciences Research Involving Humans
• Learn about the CTTI Quality by Design project at www.ctti-clinicaltrials.org
• CTTI Recommendations: Efficient and Effective Clinical Trial Recruitment Planning
• Presentation (Nov 2, 2018): Designing Your Research Study: Essential concepts, Best practices, Pitfalls, Speedy IRB approval (Presenter: Paul W. Stewart, PhD)
• Clinical Protocol Development Series (see below)

Resources

• Protocol Builder by BRANY (protocolbuilderpro.com)
• UNC Scientific Review Committee (SRC)
• Online NIH Protocol Tool
• Spirit checklist
• Living Textbook of pragmatic clinical trials — a collection of knowledge from the NIH Health Care Systems Research Collaboratory
• For biostatistical consultations on study design and statistical analysis plans for clinical protocols, visit Biostatistics

Clinical Protocol Development Series

This two-day series provides researchers with knowledge, tools, and resources to aid in the development of a scientific protocol for a clinical research study. Recorded sessions for day one and day two (Spring 2023) are available below.

View slides: Day One (pdf)

View slides: Day Two (pdf)