Training

Initial Training

1. Human Subjects Protection Training – Certification of training on the protection of human research participants is required for all investigators and key personnel involved in the conduct of human subject’s research.  The Collaborative Institutional Training Initiative (CITI) online platform is utilized to meet this requirement. This training does not expire.

   Click here for instructions to access the training.
         
2. USA HIPAA in Research Training – Investigators and key research personnel that obtain/maintain protected health information* (PHI) must complete the USA HIPAA in Research Training.  The training is a self-guided training.  A certificate of completion is available at the end of the training document.  This training does not expire.
   
   PHI obtained/maintained within the 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, Speech and Health Center, and Psychology Clinic.

   * List of 18 PHI identifiers

The above training is required for your role in research.  Please refer to the Research Education and Learning Matrix for additional training requirements according to your field of study and/or type of research.  

Refresher Training 

There is no refresher training required for your role in research.  Please refer to the Research Education and Learning Matrix for additional training requirements according to your field of study and/or type of research that may require refresher training.  

Initial Training

1. Human Subjects Protection Training – Certification of training on the protection of human research participants is required for all investigators and key personnel involved in the conduct of human subject’s research.  The Collaborative Institutional Training Initiative (CITI) online platform is utilized to meet this requirement. This training does not expire.

   Click here for instructions to access the training.

2. USA HIPAA in Research Training – Investigators and key research personnel that obtain/maintain protected health information* (PHI) must complete the USA HIPAA in Research Training.  The training is a self-guided training.  A certificate of completion is available at the end of the training document.  This training does not expire. 
   
   PHI obtained/maintained within the 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, Speech and Health Center, and Psychology Clinic.
   
   * List of 18 PHI identifiers

The above training is required for your role in research.  Please refer to the Research Education and Learning Matrix for additional training requirements according to your field of study and/or type of research.  

Refresher Training 

There is no refresher training required for your role in research.  Please refer to the Research Education and Learning Matrix for additional training requirements according to your field of study and/or type of research that may require refresher training.  

Initial Training

1. Human Subjects Protection Training – Certification of training on the protection of human research participants is required for all investigators and key personnel involved in the conduct of human subject’s research.  The Collaborative Institutional Training Initiative (CITI) online platform is utilized to meet this requirement. This training does not expire.

   Click here for instructions to access the training.     

2. USA HIPAA in Research Training – Investigators and key research personnel that obtain/maintain protected health information* (PHI) must complete the USA HIPAA in Research Training.  The training is a self-guided training.  A certificate of completion is available at the end of the training document.  This training does not expire.
   
   PHI obtained/maintained within the 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, Speech and Health Center, and Psychology Clinic.
   
   * List of 18 PHI identifiers
   
   
3. Good Clinical Practice – All NIH-funded investigations/staff involved in the conduct, oversight, or management of clinical trials are required to complete GCP training, consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).  Training in GCP complements other NIH training requirements on protections for human subjects.
   
   The FDA requires GCP compliance for studies conducted under an investigational new drug application or investigation device exemption.  GCP describes the responsibilities of investigators, sponsors, monitors, and IRBs in the conduct of clinical trials.  GCP training must be refreshed at least every three years in order remain current with regulations, standards and guidelines.
   
   Acceptable GCP online courses:
   
   * Any GCP modules that have been TransCelerate approved.  A list of approved modules can be found here.
   
   * Collaborative Institutional Training Initiative (CITI) – To access this training, register a new account.  Be sure to mark your affiliation with the University of South Alabama in order to receive the training for free.  Complete the registration process to access the module title 'CITI Good Clinical Practice Course'.

The above training is required for your role in research.  Please refer to the Research Education and Learning Matrix for additional training to your field of study and/or type of research.  

Refresher Training

1. Good Clinical Practice – GCP expires every 3 years and, therefore, must be refreshed.  The courses listed under Initial Training are acceptable to be repeated for refresher training.  

Refer to the Research Educational and Learning Matrix for additional training requirements according to your field of study and/or type of research that may require refresher training.  

Initial Training

1. Human Subjects Protection Training – Certification of training on the protection of human research participants is required for all investigators and key personnel involved in the conduct of human subject’s research.  The Collaborative Institutional Training Initiative (CITI) online platform is utilized to meet this requirement. This training does not expire.

   Click here for instructions to access the training.

2. USA HIPAA in Research Training – Investigators and key research personnel that obtain/maintain protected health information* (PHI) must complete the USA HIPAA in Research Training.  The training is a self-guided training.  A certificate of completion is available at the end of the training document.  This training does not expire. 
   
   PHI obtained/maintained within the 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, Speech and Health Center, and Psychology Clinic.
   
   * List of 18 PHI identifiers
   
   
3. Good Clinical Practice – All NIH-funded investigations/staff involved in the conduct, oversight, or management of clinical trials are required to complete GCP training, consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).  Training in GCP complements other NIH training requirements on protections for human subjects.
   
   The FDA requires GCP compliance for studies conducted under an investigational new drug application or investigation device exemption.  GCP describes the responsibilities of investigators, sponsors, monitors, and IRBs in the conduct of clinical trials.  GCP training must be refreshed at least every three years in order remain current with regulations, standards and guidelines.
   
   Acceptable GCP online courses:
   
   * Any GCP modules that have been TransCelerate approved. A list of approved modules can be found here.
   
   * Collaborative Institutional Training Initiative (CITI) – To access this training, register a new account.  Be sure to mark your affiliation with University of South Alabama in order to receive the training for free.  Complete the registration process to access the module title 'CITI Good Clinical Practice Course'. 
   
   
4. Biohazardous Packaging and Shipping – Any personnel that will be handling and shipping biohazards (including dry ice) require this training.  You must complete the Category B Guidelines which is a self-paced review exam.  The exam will need to be emailed to Jennifer Chaplin at jchaplin@southalabama.edu.  A certificate will be sent to you upon exam verification.
   
   The Biohazardous Packaging and Shipping training expires every two years.
   
   
5. Orientation on Clinical Research Fundamentals – Orientation 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 an affiliated key research personnel involved in the coordination of and oversight of clinical research activities.  

The above training is required for your role in research.  Please refer to the Research Education and Learning Matrix for additional training requirements according to your field of study and/or type of research.  

Refresher Training 

1. Good Clinical Practice – GCP expires every 3 years and, therefore, must be refreshed.  The courses listed under Initial Training are acceptable to be repeated for refresher training.
   
   
2. Biohazardous Packaging and Shipping – This training expires every 2 years and, therefore, must be refreshed.  The course listed under Initial Training is acceptable to be repeated for refresher training.  

Refer to the Research Education and Learning Matrix for additional training requirements according to your field of study and/or type of research that may require refresher training.  

Seminar and Classroom Lectures

Contact Dusty Layton, Director, Research Compliance and Assurance at dlayton@southalabama.edu or 460-6625 if you would like to arrange a training session. 

DHHS Office of Research Integrity: The Research Clinic

This interactive training video educates clinical and social researchers on the importance of appropriately protecting research participants and avoiding research misconduct. The Research Clinic provides users to assume various roles in conducting research and determines the outcome of the storyline through selection of deciding on the course of action for each “playable” character. The video can be accessed here.