Investigator Training Checklist - Biomedical

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NOTE: This checklist is provided as a guide to facilitate training for investigators working in a biomedical setting. University-required
training is identified with asterisks in the applicable activities’ description. In some instances the required training elements are
study and/or role-specific; please eliminate and/or insert training elements as required (additional training resources for your
consideration are available in OHSP’s “Study Team Member Training & Resource Reference List” document). In the event that you
are unsure whether the element is required, please contact the element’s department/division directly (e.g., if you are unsure
whether HIPAA Privacy and Security training is required, please contact the Research Privacy Officer directly). If you would like
guidance on developing departmental and/or study team training standards, contact Kelly Unsworth at (585) 275-5244 or
[email protected]
Investigator Basic Training Checklist – Biomedical Research
Employee Name:
Job Title:
Job Code:
Supervisor:
Department/Division:
Activity/Resource
Human Subjects Research Training (CITI Program)
Hyperlink
Link
* Required prior to conducting any human subjects research
OHSP Education & Training Framework
 OHSP Orientation to Conducting Human Subject Research
 OHSP Research Boot Camp
 OHSP Core Training Module 2: PI Oversight
 OHSP Core Training Module 3: Financial Management
 OHSP Core Training Module 6: Informed Consent
 OHSP Core Training Module 7: Investigational Products
Link
(Note that this module consists of ORPA Blackboard Course CT-01 and
ORPA’s Clinical Research Studies Financial Training.)
 OHSP Core Training Module 8: Subject Safety
 OHSP Core Training Module 10: Quality Management
ROSS (RSRB Online Submission System) Training
Link
Training modules are provided on the OHSP website. Alternatively classroom training
is available the 3rd Monday of every month from 2-3pm in the OHSP Office (contact
Suzanne Flanigan at x53050 on global to sign up)
ORPA Blackboard Course: Overview of Clinical Research Billing Policy
and Standard Operating Procedures (Course CT-01)
ORPA Blackboard Course: UR Conflict of Interest Policy (Course UR
ORPA COI Policy)
ORPA’s Clinical Research Studies Financial Training
Link
Link
This training consists of a combination of online videos and work group sessions.
Contact [email protected] to register for the in-person work group
sessions and for instructions on accessing the online material.
HIPAA Privacy and Security Training
Link
* HIPAA Privacy and Security training may be required based on an employee’s role
within the University. Requirement information can be found here: Link
Orientation Requirements for FDA Investigational New Drug
Applications & Orientation to Medical Devices and the Requirements
for FDA Investigational Device Exemption Applications (CTSI FDA
Page 1 of 2
8/24/2015
Link
Date
Completed
Trainee’s
Initials
Training)
* Required for investigators prior to any IND or IDE submissions (training is optional,
but strongly recommended for study team members working on FDA-related aspects
of the study
Radiation Safety Training
Link
* Required for all prospective users of radioactive material.
Environmental Health & Safety: OSHA Required Training
* Required for all staff working in labs or supervising lab personnel (customized
training for Clinical Lab Personnel, Phlebotomists & Clinical Study Coordinators and
Research Lab Personnel)
Page 2 of 2
8/24/2015
Link
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