|
|
Protocol Review and Development 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
|
|