September 22, 2015
Jane Q. Investigator
Case Western Reserve Univesity School of Medicine
Department of Gastroenterology
Cleveland, OH 44106-XXX
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 10040 – MSN 7710
Bethesda, MD 20892-7710
Re: National Institutes of Health Requirement for Training and Education of Key Personnel
Dear XXX:
This is to notify the National Institutes of Health that all key personnel who are responsible for the
design and conduct of the project, [insert project title and number], have been trained in the protection
of human subjects. This project is scheduled for funding in FY 2001 or later. There are currently four (4)
individuals properly characterized as key personnel and fitting the definition as provided in the instructions
section of Public Health Services Form 398. They are listed below along with a brief description of the
training each has received.
Jane Q. Investigator, MD – Principal Investigator
☐ Currently certified through CWRU’s Continuing Research Education Credit (CREC) Program.
This program currently requires researchers to complete CITI BASIC Training to enter the program and
achieve initial certification. To maintain this certification a researcher must earn 12 credits every three
years through education and training in human subject protections. Information about the program can
be found at crec.case.edu. Attached is a copy of their current training certificate.
1.
Ken M. McInvestigator, PhD – Co-Investigator
☐ Currently certified through CWRU’s Continuing Research Education Credit (CREC) Program.
This program currently requires researchers to complete CITI BASIC Training to enter the program and
achieve initial certification. To maintain this certification a researcher must earn 12 credits every three
years through education and training in human subject protections. Information about the program can
be found at crec.case.edu. Attached is a copy of their current training certificate.
2.
Kim Personnel, RN – Nurse Coordinator
Received training by completing the education requirements of the Cleveland Clinic. These
requirements include the completion of CITI BASIC with continuing education through CITI Refresher
Course(s).
3.
☐
Carolyn Manager, M.B.A. – Project Manager
Received training by completing the education requirement of the University of Michigan. See
attached letter confirming such education.
4.
☐
This letter is intended to serve as documentation that the key personnel have been properly trained.
Sincerely,
Jane Q. Investigator
Responsible Investigator
Bob I. Official
Institutional Official