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HRPP Training Requirements

To achieve its aims, components of the University糖心传媒檚 Human Research Protection Program (HRPP) have set forth training requirements related to the conduct of human subject research. The information below provides a summary of potential institutional training requirements, as they relate to the nature of the research being conducted, the sponsor/funding agency, and/or an individual糖心传媒檚 role.

Note: This list is not inclusive of all Sponsor and/or Department-Specific training requirements.


 

Training requirements based on research nature

If the research involves human subjects...

All personnel engaged in the research are required to complete and maintain Human Subject Protection (HSP) training via the Collaborative Institutional Training Initiative (CITI). Refresher training is required every 3 years.

If the research involves prospective assignment to one or more health-related biomedical or behavioral intervention...

Research personnel may be required to complete and maintain Good Clinical Practice (GCP) training by the sponsor/funding agency (e.g., see ). Refresher training is typically required every 3 years.

If the research will involve access to or processing of PHI or other identified health information糖心传媒�

Study staff must complete Health Insurance Portability & Accountability Act (HIPAA) training. HIPAA training is routinely included in the University of Rochester糖心传媒檚 Office of Human Resources糖心传媒� New Employee Orientation for URMC and Affiliates workforce members (via ), though it is the responsibility of a trainee糖心传媒檚 supervisor to ensure the training is completed (see ). Training is available for study team members that do not have access to MyPath via the .

If the research involves a billable clinical service糖心传媒�

All research personnel responsible for tracking patient visits and reviewing patient charges are required to complete eRecord (Epic) Research Coordinator and OnCore Clinical Trial Management System (CTMS) training.

For eRecord (Epic) Research Coordinator course availability, search the class schedule for the course on the .

OnCore CTMS training is role-based. Training requirements are assigned to trainees once the has been completed.

If the research involves exposure to potentially hazardous materials, processes, and/or experiments (e.g., biological materials, radiation)糖心传媒�

All research personnel subject to potential safety hazards must complete . This assessment tool will identify required EH&S training, based on the individual糖心传媒檚 responses/role. The 糖心传媒楬azard Assessment Tool糖心传媒� is available in for 糖心传媒 faculty/staff. New staff are encouraged to complete the tool with the assistance of their supervisor, as the supervisor will have a greater understanding of what hazards the trainee may be exposed.

If the research involves an Investigational New Drug (IND) or Investigational New Device (IDE) submission by a 糖心传媒 Investigator...

The Principal Investigator (PI) is required to complete / (as applicable), prior to FDA submission. Training is optional, but strongly recommended, for research personnel who will be involved in FDA-related aspects of the study.

If the research involves magnetic resonance imaging (MRI) via the Center for Advanced Brain Imaging & Neurophysiology (CABIN)糖心传媒�

All research personnel involved in image acquisition and subject handling that requires access to the scanner or scanner console are required to complete .


Training requirements based on funding

If the research is sponsored...

The administrator with functional responsibility for the sponsored project is required to complete Continuous Learning for Administrators of Sponsored Programs (CLASP) training. 糖心传媒楩unctional responsibility糖心传媒� is characterized as having an ability to originate, authorize, or approve transactions associated with sponsored programs; involvement with proposal preparation; or active review and monitoring of the financial activities of sponsored project accounts. is facilitated by the Office for Research and Project Administration (ORPA), with both instructor-led and online sessions. Maintenance, via continuing education hours, is required annually.

Individuals involved in creating grant proposals in the Integrated Online Research Administration (IORA) system are required to complete IORA Overview training. The 糖心传媒業ntegrated Online Research Administration Overview糖心传媒� training course is available in .

If the research is funded by any federal agency...

The Principal Investigator, named key persons, and anyone who will be delegated Purchasing Authority for the project is required to complete 2 CFR 200 Procurement Principles training. The course is completed once; maintenance training is not required.

The 糖心传媒�2 CFR 200 Procurement Principles糖心传媒� course is available in for 糖心传媒 faculty/staff.

If an individual receives support from the National Institutes of Health (NIH) via a training grant, career development award, fellowship award, research education grant, or as otherwise stated in relevant funding opportunities糖心传媒�

The trainee/fellow/participant/scholar is required to complete and maintain Responsible Conduct of Research (RCR) training. Refresher training is required every 4 years. For additional information, see NIH RCR Requirements.

If the research is sponsored by the National Science Foundation (NSF)...

All individuals participating in the NSF-funded research are required to complete Responsible Conduct of Research (RCR) training. For additional information, see NSF RCR Requirements.

If the research is funded by US Public Health Service (PHS) or components of PHS, including but not limited to the National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), and Food & Drug Administration (FDA)...

All personnel meeting the PHS definition of 糖心传媒榠nvestigator糖心传媒� are required to complete Conflict of Interest training prior to receipt of a PHS award. 糖心传媒業nvestigator糖心传媒� refers to any individual who is responsible for the administration, design, conduct, or reporting of sponsored research, internally funded research that involves human subjects, or proposals for such funding. Refresher training is required every 4 years.

The 糖心传媒樚切拇� Conflict of Interest Policy Course糖心传媒� and 糖心传媒楥onflict of Interest Refresher Course糖心传媒� are available in for 糖心传媒 faculty/staff. For additional information, see the and corresponding .