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

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 http://elpaso.ttuhsc.edu/research/committees/irb/_documents/HRPP%20Manual%20El%20Paso%20September%202015.pdf

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 https://www.citiprogram.org/

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 http://elpaso.ttuhsc.edu/research/committees/irb/_documents/HRPP%20Manual%20El%20Paso%20September%202015.pdf

CITI Instructions for Initial Registration Go to https://www.citiprogram.org/ 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 http://elpaso.ttuhsc.edu/research/committees/irb/_documents/HRPP%20Manual%20El%20Paso%20September%202015.pdf

Adding a Course on CITI https://www.citiprogram.org/ Go to https://www.citiprogram.org/ 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 https://www.citiprogram.org/

Financial Disclosure Instructions Go to https://elpasottuhsc.co1.qualtrics.com/jfe/form/SV_6PhkhvolTTBWMUR 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

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.” http://elpaso.ttuhsc.edu/research/committees/irb/_documents/HRPP%20Manual%20El%20Paso%20September%202015.pdf

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.” http://www.ttuhsc.edu/hsc/op/op75/op7513.pdf

Packaging and Shipment of Infectious Materials We currently use the hazardous material shipping training from Mayo Clinic http://www.mayomedicallaboratories.com/education/online/dangerousgoods/index.html

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 http://www.ttuhsc.edu/admin/safety/training.aspx

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

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

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

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.” http://elpaso.ttuhsc.edu/opp/_documents/73/op7304.pdf

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. http://elpaso.ttuhsc.edu/research/committees/ibc/default.aspx

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!

Summary In order to gain access to iRIS study personnel must complete CITI training, Financial Disclosure, and request an iRIS account at https://ttuep.imedris.net/ 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

Resources TTUHSC El Paso HRPP Manual: http://elpaso.ttuhsc.edu/research/committees/irb/_documents/HRPP%20Manual%20El%20Paso%20September%202015.pdf CITI Program https://www.citiprogram.org/ TTUHSC EP Financial Disclosure https://elpasottuhsc.co1.qualtrics.com/jfe/form/SV_6PhkhvolTTBWMUR Mayo Clinic Dangerous Goods Training http://www.mayomedicallaboratories.com/education/online/dangerousgoods/index.html Safety Services Program Training http://www.ttuhsc.edu/admin/safety/training.aspx IBC Webpage http://elpaso.ttuhsc.edu/research/committees/ibc/default.aspx TTUHSC EP OP 73.13 http://www.ttuhsc.edu/hsc/op/op75/op7513.pdf TTUHSC EP OP 73.04 http://elpaso.ttuhsc.edu/opp/_documents/73/op7304.pdf

Questions?