Training

1. All students are required to complete Human Subjects Protection training for IRB submission purposes. The Collaborative Institutional Training Initiative (CITI) online platform is utilized to meet this requirement. This training does not expire.
   
   For instructions on how to access and complete this training, click here. If you have completed an equivalent CITI module at a previous institution, this certificate will suffice at USA.
   Note: If you have an existing CITI account but have not completed this particular training, please reference the above guidance document and begin at Step 5. You may need to add an affiliation with USA if your account originated at an outside institution.
   
   
2. Protected health information (PHI) obtained/maintained within a USA Health Systems Covered Entity must comply with HIPAA privacy and security training requirements. USA Covered Entities include USA Hospitals, USA Physician’s Group Clinics, Mitchell Cancer Institute, the Speech Pathology and Audiology Clinic, Physical Therapy Clinic and Psychology Clinic.
   
   

   Any student accessing, recording or maintaining protected health information (PHI) within one of these HIPAA Covered Entities for research purposes must complete USA HIPAA in Research training. This training can also be located in the USA IRB Documents for Researchers library within IRBNet Forms and Templates. This training does not expire.

   Full list of HIPAA PHI identifiers.

1. All DNP students are required to complete Human Subjects Protection training for IRB submission purposes. The Collaborative Institutional Training Initiative (CITI) online platform is utilized to meet this requirement. This training does not expire.
   For instructions on how to access and complete this training, click here.
   
   
2. All DNP students are required to complete USA HIPAA in Research training. This training can also be located in the USA IRB Documents for Researchers library within IRBNet Forms and Templates. This training does not expire.

1. All personnel engaged with human subjects (e.g., obtaining consent, interacting with participants, etc.) are required to complete Human Subjects Protection training for IRB submission purposes. The Collaborative Institutional Training Initiative (CITI) online platform is utilized to meet this requirement. This training does not expire.
   
   For instructions on how to access and complete this training, click here. If you have completed an equivalent CITI module at a previous institution, this certificate will suffice at USA.
   
   Note: If you have an existing CITI account but have not completed this particular training, please reference the above guidance document and begin at Step 5. You may need to add an affiliation with USA if your account originated at an outside institution.
   
   
2. Protected health information (PHI) obtained/maintained within a USA Health Systems Covered Entity must comply with HIPAA privacy and security training requirements. USA Covered Entities include USA Hospitals, USA Physician’s Group Clinics, Mitchell Cancer Institute, the Speech Pathology and Audiology Clinic, Physical Therapy Clinic and Psychology Clinic.
   
   Any personnel accessing, recording or maintaining protected health information (PHI) within one of these HIPAA Covered Entities for research purposes must complete USA HIPAA in Research training. This training can also be located in the USA IRB Documents for Researchers library within IRBNet Forms and Templates. This training does not expire.
   
   A full list of HIPAA PHI identifiers can be seen here.

1. All individuals engaged with human subjects (e.g., obtaining consent, interacting with participants, etc.) are required to complete Human Subjects Protection training for IRB submission purposes. The Collaborative Institutional Training Initiative (CITI) online platform is utilized to meet this requirement. This training does not expire.
   
   For instructions on how to access and complete this training, click here. If you have completed an equivalent CITI module at a previous institution, this certificate will suffice at USA.
   
   Note: If you have an existing CITI account but have not completed this particular training, please reference the above guidance document and begin at Step 5. You may need to add an affiliation with USA if your account originated at an outside institution.
   
   
2. Protected health information (PHI) obtained/maintained within a USA Health Systems Covered Entity must comply with HIPAA privacy and security training requirements. USA Covered Entities include USA Hospitals, USA Physician’s Group Clinics, Mitchell Cancer Institute, the Speech Pathology and Audiology Clinic, Physical Therapy Clinic and Psychology Clinic.
   
   Any personnel accessing, recording or maintaining protected health information (PHI) within one of these HIPAA Covered Entities for research purposes must complete USA HIPAA in Research training. This training can also be located in the USA IRB Documents for Researchers library within IRBNet Forms and Templates. This training does not expire.
   
   A full list of HIPAA PHI identifiers can be seen here.
   
   
3. Good Clinical Practice (GCP) training is required for all NIH-funded investigations/staff involved in the conduct, oversight, or management of clinical trials. The FDA requires GCP compliance for studies conducted under an investigational new drug application or investigational device exemption.
   
   Acceptable GCP online courses include:
   • Any GCP modules that have been TransCelerate approved.
   • CITI GCP training. To access this training, please click here.
     GCP training expires every 3 years and, therefore, must be refreshed.
     
     
4. All study personnel responsible for the transport or shipping of biospecimens/biohazards must complete CITI Shipping and Transport of Regulated Biological Materials training. To access this training, please click here.
   
   This training is valid for 2 years.
   
   If you have completed an equivalent module from a reputable source, this will suffice for USA IRB purposes. Please note that if no expiration date is listed on the current certificate one will be given in order to ensure annual training.
   
   
5. Orientation on Clinical Research Fundamentals sessions are periodically scheduled to provide instruction on the basic fundamentals of clinical trial management. These sessions are designed for the novice clinical research coordinator and affiliated key research personnel involved in the coordination and oversight of clinical research activities.

All unaffiliated personnel are required to provide proof of Human Subjects Protection training from their institution. Additional training may be required depending on the type of research being conducted.

A Research Education and Learning Matrix has been developed as a guide to help the research community quickly identify appropriate training requirements. It is organized by research activity and includes links for additional guidance and contacts. We encourage you to use or share this matrix guide with any new or existing research personnel to assist with training requirements.