The Project Team Unit reviews investigator-initiated human research protocols and informed consent documents to determine the presence of basic elements and the coherency of objectives, design, and methodology. If necessary, based upon their professional experience, the staff will provide constructive comments/suggestions to the Principal Investigator and research staff. The staff is also available to assist with protocol development, including the provision of templates and IRB required language. The Project Team Unit facilitates the involvement of the other RSC units when needed to promote high quality FDA and non-FDA clinical research projects.


Protocol Templates

Which template should I use?

FDA Research Protocols
• FDA Protocol Template
• FDA Protocol Template Instructions
• Tips for Writing FDA Protocols


Non-FDA Research Protocols
• Non-FDA Protocol Template
• Non-FDA Protocol Template Instructions
• Tips for Writing Non-FDA Protocols

If you need assistance modifying a template based on your study design or have questions about how to get started, please contact Dr. Ricki Helm at 501-686-5961 or HelmRickiM@uams.edu.



Project Team Unit Staff:

• Ricki Helm, PhD, Project Team Unit Manager, 501-686-5961

• Amy Jo Jenkins, Project Manager, 501-686-5939

• Cindy Witkowski, Project Manager (Winthrop P. Rockefeller Cancer Institute),
   501-296-1504, extension 1664