Protocol Development and Finalizing Analysis Plans
How can you get design and statistical support for protocol development and statistical analysis plans?
After you’ve completed project development, the next step in a research project is developing research protocols and finalizing your analysis plans.
The protocol defines all procedures and processes that are a part of your research. Those procedures and processes must be created and approved before beginning any study activities with participants.
Protocols and analysis plans are important to:
- Define your study activities and analyses
- Ensure the study team performs all procedures correctly
- Ensure that your intended analyses are designed and shared before the study is conducted
- Allow other investigators to possibly replicate your work in the future
Tools, templates, and resources exist to help you achieve this step.
Receive Assistance with Developing a Research Protocol
NIH Resources
The National Institutes of Health has tools and templates to help you develop a protocol that is tailored to match your research needs.
UT Southwestern Resources
The UT Southwestern Human Research Protection Program (HRPP) provides a protocol template that can assist you with the development of your protocol for submission to the IRB.
Conducting cancer-related research
All cancer-related clinical and population science studies conducted at UT Southwestern and affiliated health care systems (e.g., Parkland Health and Hospital System, Children’s Medical Center) are subject to review by the Protocol Review and Monitoring System (PRMS) of the Clinical Research Office (CRO) of the Harold C. Simmons Comprehensive Cancer Center. The CRO has resources available to support investigators in the development of materials for this review process.
Get Design and Statistical Support
The Biostatistics, Epidemiology, and Research Design (BERD) Program provides researchers with high-quality advice on study design (including sample size estimations and power calculations), and state-of-the-art analytic methods to maximize interpretability, reliability, and generalizability of data generated by our clinical and translational research projects. It also provides critical methodologies guidance and expertise to clinical and translational investigators at all phases of their research projects, regardless of their level of training.
The success of a project is greatly enhanced by engagement of statisticians and design experts during the planning phase of a study. As protocols and statistical analysis plans are being finalized, the BERD Team can provide consultation and assistance as needed.
Services
The UT Southwestern CTSA Program sponsors a one hour consultation at no charge for researchers at UT Southwestern and our partnering institutions who need study design guidance and statistical support. Investigators with grant support can allocate effort for faculty and staff statisticians on their grants or pay for BERD services.
Support for KL2 Clinical Research Scholars is ongoing and provided free of charge for a variety of purposes including design and conduct of independent research projects, pilot awards, and extramural funding (limited to a total of 4 years from the date of entry into the Clinical Scholars Program or until the Scholar is promoted to Associate Professor, whichever occurs first).
CTSA Pilot Grant Recipients can receive support based on the following fee structure:
- $1,000 for minimal support (about 20 hours)
- $3,000 for midlevel support (20-50 hours)
- $5,000 for in-depth support (more than 50 hours)
Ready to consult with BERD experts?
BERD@utsouthwestern.edu the BERD team to schedule a consultation.