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.

• Elements of a Clinical Research Protocol
   

• Suggested Language for Select Protocol Sections
   

• Tips for Writing Human Subject Research Protocols
   

• ICF IRB Policy 15.1 pdf
   

• IRB Policy 10.3 pdf

If you need assistance modifying a template based on your study design or have questions about how to get started, please contact David Avery at 501-686-7093, DAAvery@uams.edu or John Seng at 501-686-5961, JESeng@uams.edu.



Project Team Unit Staff:

• David Avery, Project Team Manager, 501-686-7093

• Cindy Witkowski, Project Manager (Winthrop P. Rockefeller Cancer Institute),
   501-526-6990 ext. 8026

• John E. Seng, Ph.D., Project Manager,  501-686-5961