Training Requirements for Conducting Human Subject Research

Right to Know Basic Awareness with the Global Harmonized System

Required for all faculty, staff & students

• Completed By: Immediately upon employment
• Available: As part of online new employee orientation or at https://www.usg.edu/facilities/resources/training/
• Format: Web-based
• Length: 15 minutes
• Frequency:  Once
• Contact: Division of Environmental Health and Safety @ 706-721-2663

HIPAA

Required for all faculty, staff & students

• Completed By: By assigned completion date
• Available: Via email with 2 weeks of employment state date
• Format: Web-based link provided in email
• Length: 1-1.5 hours
• Frequency: When assigned & during Annual Compliance
• Contact: Audit and Compliance @ 706-721-2663

Collaborative Training IRB Initiative (CITI) Training

Human research protection training required for all research team members listed on Institutional Review Board (IRB) submission:

• Complete By: Must be completed before working on any IRB approved study, complete Learner Group 1 – FDA Regulated Research
• Available: At any time
• Format: Web-based program (www.citiprogram.org)
• Length: 4-6 hours
• Frequency: Recertification required every three years
• Contact: Clinical Research Training Coordinator, Institutional Review Board Office @ 706-721-3110

Human Research Academy

Required for all new research team members conducting human subject research

• Complete By: Within 6 months of employment or being added to a research team
• Available: After completing CITI training
• Format: Classroom Lecture and Didactic training
• Length: 1 week generally ½ day sessions in the morning
• Frequency: Once (offered in April and October each year; 8 a.m. to 12:30 p.m.
• Contact: SVP’s Office – 706-721-6900

Human Research Academy

Required for all new research team members conducting human subject research

• Complete By: Within 6 months of employment or being added to a research team
• Available: After completing CITI training
• Format: Classroom Lecture and Didactic training
• Length: 1 week generally ½ day sessions in the morning
• Frequency: Once (offered in April and October each year; 8 a.m. to 12:30 p.m.
• Contact: SVP’s Office – 706-721-6900 

IRBNet Training

For all new research team members who use the electronic IRB submission system to submit regulatory and other study related documents.

• Complete By: As assigned
• Available: Check with IRB Training Office
• Format: Classroom support training or online documents
• Length: 5 - 2 hours and other times as needed
• Frequency: As needed
• Contact: Clinical Research Training Coordinator, Institutional Review Board Office @ 706-721-3110

Research Team Member Orientation

Recommended for new research team members

• Available: Upon employment
• Format: Informal introductions, discussions, and tour of research administration and Environmental, Health and Safety
• Length: 3 hours
• Frequency: Once
• Contact: SVP’s Office @ 706-721-6900

Initial Biosafety and Blood Borne Pathogen Training

Required for anyone working with hazardous biological materials, including human specimens

• Complete By: Before working with biological specimens or before being involved in an IBC protocol submission or amendment
• Available: Assigned by Biosafety Office
• Format: Online after assignment is made at https://train.augusta.edu/d2l/home
• Length: 2+ hour
• Frequency: When assigned by supervisor and during Annual Compliance
• Contact: Division of Environmental Health and Safety @ 706-721-2663

Initial Chemical Safety Training

Required for anyone working with chemicals in a laboratory

• Complete By: Before working in a laboratory
• Available: Monthly, last Wednesday or Thursday of the month at 1 p.m. (Registration Required)
• Format: Didactic
• Length: 2 hours
• Frequency: When assigned by supervisor and during Annual Compliance
• Contact: Division of Environmental Health and Safety @ 706-721-2663

Shipping of Biological Substances and Support Materials

Required for anyone shipping dangerous good, potentially infectious substances, or using dry ice (Clinical/diagnostic/biological samples, anything on dry ice)

• Complete By: Before shipping dangerous or infectious goods
• Available: As needed
• Format: Online
• Length: 2+ hours
• Frequency: When assigned by supervisor and during Annual Compliance
• Contact: Division of Environmental Health and Safety @ 706-721-2663

Right to Know Hazardous Waste Awareness

Required for chemical users

•  Completed By: Prior to working in a laboratory
• Available: Upon Employment
• Format: Web-based - http://www.usg.edu/facilities/resources/training/
• Length: 15 minutes
• Frequency: Initially and with Annual Compliance
• Contact: Division of Environmental Health and Safety @ 706-721-2663

Radiation Safety Initial Training Course

Required for anyone working with radioactive material or radiation emitting equipment

• Available: Offered monthly on the 2^nd Friday at 8 am (Registration Required)
• Format: Classroom lecture
• Length: 6 hours
• Frequency: Initially and then with Annual Compliance
• Contact: Environmental Health and Safety Office @ 706-721-9826

 

Oncore Training

Required for all Clinical Research Coordinators, there are several classes

• Available: Check Oncore Website
• Format: Classroom lecture – video introductions also available, but must attend the classes
• Length: 1-6 hours, dependent upon course being taken
• Frequency: As needed
• Contact: Oncore@augusta.edu

Regulatory Binder Training

Required for all Clinical Research Coordinators, there are several classes

• Available: Check with CTO Manager
• Format: Classroom lecture
• Length: 2 hours
• Frequency:  Offered about every 6 weeks by CTO 
• Contact: CTO Manager @ 706-721-0193

Study Start-up Training

Required for all Clinical Research Coordinators there are several classes

• Available: Check with CTO Manager
• Format: Classroom lecture
• Length: 5 hours
• Frequency:  Offered about every 6 weeks by CTO 
• Contact: CTO Manager @ 706-721-0193

Audit Findings Review

Required for all Clinical Research Coordinators, there are several classes

• Available: Check with CTO Manager
• Format: Conference Room Staff Discussion
• Length: 30 minutes of staff meeting
• Frequency: 3^rd Tuesday of each month
• Contact: CTO Manager @ 706-721-0193

Human Research Academy 201 and 301

Required for all Clinical Research Coordinators based on their role in their area

• Available:  Currently being reworked and will be announced
• Format: Lecture/Discussion
• Length: 1-3 hours, depending on how new format is developed
• Frequency: Each class is offered every 12 weeks
• Contact: Watch for announcements of classes reopening.

Additional Training

Other training as assigned by study sponsors, including training for Interactive Voice Response Training (IVRS) and remote data entry (RDC), vendor-specific training, investigator meetings, and on-site training with monitors.