Working with the Clinical Research Center

Please include this checklist when submitting your documentation to the Clinical Research Center Administration Office.

CRC requires the following training and documentation from all investigators and staff who use the CRC:

1. CITI - Completion of the Biomedical Research or Social & Behavioral Research Track (as appropriate to the research being conducted) of the Collaborative Institutional Training Initiative (CITI) Course in the Protection of Human Research Subjects. Additional information, including course access instructions are available. 
2. HIPAA Privacy Protection Training - Several options are available: 
   • Through the CITI program: https://www.citiprogram.org as an optional course 
   • Provide documentation of HIPAA training from another source for example hospital or other training course 
3. Good Clinical Practice 
   • Provide documentation of Good Clinical Practice training from another source for example a sponsor or other training course 
   • Through the CITI program as an optional course. 

For investigators and staff conducting research at the University at Buffalo:

The UB Institutional Review Board (UBIRB) requires researchers and their staff to complete in-person Good Research Practice training. Check upcoming sessions or register.

The following are required for investigators and staff depending on the activities that you plan to perform within the CRC.

• Training for the preparation and shipment of dangerous goods: 
  • Through any IATA (International Air Transport Association) approved course. Multiple sites/courses are available.
  • One free site that will comply with requirement: 
    • i. http://www.mayomedicallaboratories.com/education/onl ine/dangerousgoods/index.html 
• Exposed to Blood Borne Pathogens (i.e., handling blood of body fluids) 
  • Training on the epidemiology, symptoms and transmission route 
  • Multiple sites are available for training. 
    • UB Classroom
    • Current documentation from hospital or other training course 
• Using Radioisotopes/Radiopharmaceuticals
• Basic Life Support/CPR/AED Training: 
  • At least one member of the research staff in attendance during subject visits utilizing a medication or invasive intervention must have a current certificate in CPR/Basic Life support. 
    • Documentation of training required. 
  • Read the CRC policy and procedure “Medical Emergency Procedures within the Outpatient Clinical Research Center"
• Use of the CRC laboratory:
  • Read the Lab Training Module 
  • Take the Lab Training Post Test with a passing score of 80%.
•  Job specific training provided by sponsors: 
  • Submit copies of pertinent training certificates for each of the research staff who completed protocol specific training provided by the sponsor or principal investigator in the form of investigator meetings or on-site training. 

Each of these documents will be kept on file in the CRC and thus will need to be completed just once (with some requiring periodic renewal as per the IRB Office).