Training

All personnel involved in human subjects research at USA - including faculty, staff, students, and unaffiliated personnel - must complete Human Subjects Protection Training prior to or during the IRB pre-approval process. This requirement applies to anyone obtaining consent, interacting with participants, or accessing / handling identifiable data for research purposes.

Training is completed through the Collaborative Institutional Training Initiative (CITI). Both 'Biomedical' and 'Social-Behavioral-Educational' courses are offered - you will need to complete the training that matches your research type. 

• New to training or adding a module? View the CITI Access and Completion Instructions to get started.
• Updating an existing CITI account? Follow the instructions starting at Step 5. If your account was created at at another institution, you may need to add an affiliation with USA.
• Expiration and Renewal: The University of South Alabama does not require Human Subjects training to be renewed and certificates do not include an expiration date. However, individual sponsors or funders may require training to be renewed at certain intervals. Training may be repeated through the CITI portal. 
• Already received this training at another institution? The USA IRB will accept an equivalent CITI certificate completed at another institution.

All personnel - including faculty, staff, and students - who access, record, or maintain Protected Health Information (PHI) for research purposes within a USA HIPAA Covered Entity must complete USA HIPAA in Research training. This training does not expire.

Completion and Submission Requirements:

• Review the USA HIPAA in Research Training Document and sign the final page.
• Upload the signed certificate to your IRBNet profile or include it directly within your IRBNet study submission.

USA Covered Entities:

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
• Speech Pathology and Audiology Clinic
• Physical Therapy Clinic
• Psychology Clinic

For a comprehensive list of covered entities, please refer to the bottom section of the USA Health Privacy Notice. 

To review what constitutes PHI, see the full list of HIPAA PHI Identifiers.

All personnel involved in the design, conduct, oversight, or management of FDA-regulated or NIH-funded clinical trials must complete Good Clinical Practice (GCP) training prior to or during the IRB pre-approval process.

Training is completed through the Collaborative Institutional Training Initiative (CITI). 

• New to training or adding a module? View the CITI Access and GCP Instructions to get started.
• Updating an existing CITI account? Follow the instructions starting at Step 5. If your account was created at at another institution, you may need to add an affiliation with USA.
• Expiration and Renewal: GCP training is valid for 3 years and must be renewed prior to expiration. 
• Already received this training elsewhere? The USA IRB will accept other GCP training if the certificate states that the training has been TransCelerate approved.

 

Important Note: ICH GCP E6(R3) Guideline Update
The International Council for Harmonisation (ICH) released the revised GCP E6(R3) guidelines in January 2025, with the U.S. Food and Drug Administration (FDA) issuing subsequent implementation guidance in September 2025. CITI Program updated its GCP training platform to reflect the E6(R3) changes in late 2025.

USA IRB Requirement: The USA IRB does not require personnel with active, unexpired GCP certificates to retake training solely due to the E6(R3) update. Your current certification remains valid through its original expiration date.

Early Access and Renewal: Certain study sponsors or CROs may require research team members to complete updated E6(R3) training early. If a study sponsor requires E6(R3) training prior to your certificate's expiration, you may access and complete the updated GCP module early by logging into USA's CITI Platform and enrolling in the refresher course. 

 All study personnel responsible for transporting or shipping biospecimens or hazardous biological materials must complete Shipping and Transport of Regulated Biological Materials training prior to or during the IRB pre-approval process

This training is completed through the Collaborative Institutional Training Initiative (CITI).  

• New to Training or Adding a Module? View the Bioshipping Training Access Instructions to get started.
• Expiration: This training is valid for 2 years and must be renewed prior to expiration.
• Prior Training: Equivalent biological shipping training from a reputable source will satisfy USA IRB requirements. If the external certificate does not list an expiration date, the IRB will assign an expiration date to ensure ongoing compliance.

Once you determine which training certificate(s) you need, these must be uploaded into IRBNet. The USA IRB Office verifies training compliance for all listed study personnel during study pre-review.

While certificates can be uploaded directly to individual project submissions, linking training to your IRBNet User Profile is highly recommended to eliminate the need to upload certificates for each personnel into every new study application.

Linking training to your profile allows the IRB to automatically verify your credentials across all current and future projects:

1. Log into IRBNet and click User Profile in the top right corner.
2. Scroll to the bottom and select Add a New Training & Credentials Record.
3. Upload your completed training certificate.
4. Select Submit and choose IRB as the applicable committee.
5. Repeat for any additional certificates as needed.

For detailed guidance with screenshots, view our Step-by-Step IRBNet Profile Guide.

The Office of Research Compliance and Integrity offers a comprehensive onboarding program designed to equip new Clinical Research Coordinators with the foundational knowledge required to produce quality research. This program can be adapted to fit the individual needs of the research coordinator, with regard to department and scope of work. 

Grounded in the MRCT Clinical Research Competency Domains, CORE Training is designed to ensure that every new coordinator understands not just the "how" of research operations, but the "why" behind regulatory compliance and data integrity. The curriculum covers Ethics, GCP, Data Management, Consent, IP Handling, IRB Compliance, and Professionalism. Participants will receive a comprehensive resource toolkit featuring instructional presentations, internal policy and resource guides, and direct links to federal regulatory documents, alongside a roadmap for mandatory training and continuing education opportunities.

Contact our Office to schedule CORE Training.

The Office of Research Compliance and Integrity offers personalized training, including group or one-on-one training. Continuous education opportunities are provided throughout the year for research coordinators and investigators. Contact the Office to schedule training sessions or to inquire about planned educational sessions.

For information on educational sessions or classroom lectures conducted by the IRB Administrative Office, please contact Dusty Layton, Director of Research Compliance and Integrity at dlayton@southalabama.edu or 251-460-6625. 

For information on IRBNet presentations or demonstrations, please contact the IRB Administrator at irb@southalabama.edu or 251-460-6308.

Master the nuances of research ethics with our curated self-study modules. These interactive quizzes feature integrated links to official guidance and regulations. 

The Belmont Report

The Nuremberg Code

Clinical Research Coordinator Certification Prep