2. Training Requirements for PI and Research Staff
Training for Investigators and Research Personnel

3. True or False?
In order to gain access to iRIS, an investigator or study personnel only needs to complete their training on CITI
In order to gain access to iRIS, an investigator or study personnel must complete their trainings on CITI and their financial disclosure
FALSE

4. Which of the following trainings is not available on CITI?
Biomedical Investigator Course: Research Investigators, Research Personnel, and IRB members
Clinical Research Coordinator Course: Research personnel who are working in coordinator role
Introduction to the Principles and Practice of Bioethics
Conflict of Interest course.
The following trainings are available on CITI:
Biomedical Investigator Course: Research Investigators, Research Personnel, and IRB members
Clinical Research Coordinator Course: Research personnel who are working in coordinator role
Conflict of Interest course
Good Clinical Practices
Shipping and Transport of Regulated Biological Materials

5. True or False?
All investigators and research staff are required to renew their Biomedical Investigator Training and Clinical Research Coordinator Training at least once every 3 years, and the Conflict of Interest every 4 years. Financial disclosure must be completed on an annual basis.
All investigators and research staff are required to renew their Biomedical Investigator Training and Clinical Research Coordinator Training at least once every 3 years, and the Conflict of Interest every 4 years.
TRUE

6. CITI Instructions for Initial Registration
Go to
Select “Register”
Then select “Texas Tech University Health Sciences Center”
Continue by establishing your Username and Password
On the registration page select the
Biomedical Investigator Course
Clinical Research Coordinator Course
Conflict of Interest Course

7. Adding a Course on CITI https://www.citiprogram.org/
Go to
Log in with your Username and Password
Go to “My Learner Tools for Texas Tech University Health Sciences Center”
Select “Add a Course”
Respond to the questions on the page that pops up
Select “Submit” at the bottom of the page
The new course should now be added to your list of courses

8. Financial Disclosure Instructions
Go to
Read the disclosure form and click on “Next Page”
Select the type of disclosure
Initial Disclosure
Updated
Change in Status
Enter your demographics and select your campus and employment status
Ensure that you’ve reviewed HSCEP OP 73.09
Review and select from the list provided of significant financial interests
Enter your eRaider
Select “Next Page”
Review your submission

9. Conflicts of Interest
“In accordance with the TTUHSC Conflict of Interest in Research Policy, all research personnel are required to disclose any financial conflicts of interest as outlined in the policy. These disclosures are to be made at least annually, and are to be updated more frequently as circumstances change.” “If a project is submitted for IRB review and it is determined that a financial conflict of interest exists, the issue must be referred to the Conflict of Interest in Research Committee (COIRC)...The IRB will not continue the review of a submission until the COIRC has met and made its recommendations, and the investigator has adequately addressed these.” “All TTUHSC El Paso investigators and study personnel are bound to the policies...Unaffiliated investigators may also be bound to these policies if their own institutions do not have internal conflict of interest policies.” “Non-financial conflicts of interest (conflicts of commitment, nepotism, etc.) may also interfere with objective conduct of research activities.”

10. Packaging and Shipment of Infectious Materials
“Shippers of dangerous and regulated materials including packers must receive initial and recurrent training. This training may be provided by a commercial shipping training program, or presented or coordinated through the Safety Services Department. Copies of certifications and training programs will be maintained by the Safety Services Department, Clinical or laboratory managers/supervisors shall forward a copy of training certificates from non-HSC programs to HSC Safety Services.”

11. Packaging and Shipment of Infectious Materials
We currently use the hazardous material shipping training from Mayo Clinic

12. Safety Services Training Programs
Current Employee Refresher Training
New Employee Safety Orientation Program – NESOP Level I
New Employee Safety Orientation Program – NESOP Level II
Laboratory Safety Essentials
Fire – OP 75.16B
Emergency Preparedness

13. Sponsored Research Study-Specific Training
Training usually occurs during the Site Initiation Visit
Training can be composed of:
Electronic Data Capture system training
Equipment training
Study-specific procedure training
Training on drug dispensing
Training on how to obtain specific data
And more…
Training can also be provided by way of CDs, DVDs and web-based training modules that the sponsor or CRO provide

14. Investigator Initiated Study-Specific Training
Training should occur prior to study initiation
Training should be provided by PI or designee with PI oversight
Training can be composed of:
Electronic Data Capture system training
Equipment training
Study-specific procedure training
Training on drug dispensing
Training on how to obtain specific data
And more…
A training log and Delegation of Authority log should be maintained for record keeping purposes

15. Keep in Mind…
Other forms of training may need to occur in order to prepare study staff for subject visit, for example:
Electrocardiogram (ECG) training
Training on how to obtain vital signs
Training on how to perform certain diagnostics such as NIH Stroke Scale, Alzheimer’s MMSE, etc…
There may even need to be training on the collection or preparation of certain samples
Study personnel may even get training in phlebotomy for study purposes

16. What about When Dealing with Controlled Substances and Lab Apparatus?
“PIs must register with the federal Drug Enforcement Administration (DEA) and the Texas Department of Public Safety (DPS) to obtain the appropriate license or registration for the controlled substances to be used, prior to initially obtaining and using controlled substances.” “All licensed PIs and their authorized users shall complete the TTUHSCEP Controlled Substances Training Module every three (3) years. Authorized Users are individuals identified by the PI to conduct work with controlled substances, and who have completed all required training in the use of those materials and the applicable federal and state rules.”

17. What if I’m trying to get my Study Approved Through IBC?
The only training that is mandatory for IBC approval is Safety Services’ Laboratory Safety Essentials Training.
The following trainings are available on CITI for IBC related work:
Initial Biosafety Training
NIH Recombinant DNA Guidelines
OSHA Bloodborne Pathogens
Shipping & Transport of Regulated Biological Materials
Biosafety Retraining
Remember that one IBC approval is obtained, the approval must be posted in the lab where samples are being processed for the specific study.

18. Is there any other training I can do?
Introduction to the Principles and Practice of Clinical Research (IPPCR)
NIH Protecting Human Research Participants
SOCRA Certification Program for Clinical Research Professionals
ACRP Clinical Research Coordinator Certification
ACRP Principal Investigator Certification
ACRP Clinical Research Associate Certification
YES!

19. Summary
In order to gain access to iRIS study personnel must complete CITI training, Financial Disclosure, and request an iRIS account at
CITI training must be renewed every 3 – 4 years and Financial Disclosures must be submitted annually
Packaging and shipment of infectious materials should be completed prior to shipping procedures
Complete and maintain your safety services training
Document all study specific and non-study specific training
When in doubt, review operating procedures when dealing with controlled substances and apparatus

20. Resources
TTUHSC El Paso HRPP Manual:
CITI Program
TTUHSC EP Financial Disclosure
Mayo Clinic Dangerous Goods Training
Safety Services Program Training
IBC Webpage
TTUHSC EP OP
TTUHSC EP OP

21. Questions?