All UAB investigators and staff involved in clinical trials, regardless of funding source, are required to meet the NIH policy regarding GCP training for basic GCP training and refresher GCP training every three years. The policy can be found at Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; NOT-OD-16-148.

• Required to be taken within 2 weeks of employment into research for support staff, and prior to involvement in research by faculty
• Required in different research areas (expect this to be required campus wide) before protocol involvement [currently required for most Federally funded studies]
• Objective: understand the scientific and ethical standards of human subject research, including NIH, FDA, HHS and international clinical trial policies, guidelines and regulations
• Offered on demand on the web (24/7)
• Audience: entire research team
• Metric/Evaluation: tracked in IRAP

Basic GCP Course Instructions

1. Log in to the CITI program via UAB (use Blazer ID and UAB password): Click CITI Login Page on the UAB IRB GCP Training page.
2. This will bring you the CITI Main Menu.
3. Click Add a Course.
4. On the Select Curriculum page:
   • ​​​​​​Question 1, leave blank.
   • Question 2, check the first option, Good Clinical Practice and ICH.
   • Question 3, leave blank.
5. ​At the bottom of the page, click Submit.
6. You will be brought back to the Main Menu. The course you selected will be listed under the heading Course. Click on the course name to begin.
7. After completing the course, the Office of the IRB will be automatically notified.

Refresher GCP Course Instructions

1. Log in to the CITI program via UAB (use Blazer ID and UAB password): Click CITI Login Page on the UAB IRB GCP Training page.
2. This will bring you to the CITI Main Menu.
3. Click Add a Course.
4. ​On the Select Curriculum page:
   • Question 1, leave blank.
   • Question 2, check the second option, ICH GCP (Good Clinical Practice) Refresher Course.
   • Question 3, leave blank.

5. ​At the bottom of the page, click Submit.
6. You will be brought back to the Main Menu. The course you selected will be. Click on the course name to begin.
7. After completing the course, the Office of the IRB will be automatically notified.

You need UAB IRB training if you are an employee or student at UAB and you are listed as an Investigator or "key personnel" (see ​Key Personnel Flowchart​ for guidance); or screen potential participants and/or obtain informed consent; or have IRB-related responsibilities.

CITI Human Subjects Training course

• The UAB IRB will accept the CITI Basic Course in Human Research Protections (Biomedical or Social and Behavioral) for Initial IRB Training credit.
• Required to be taken within 2 weeks of employment for support staff, and prior to involvement in research by faculty.
• Required by the IRB and required before any human subject protocol involvement
• Objective: describe responsibilities and procedures for protecting the rights and safeguarding the welfare of human subjects who participate in research.
• Offered on demand on the web (24/7)
• Audience: entire research team
• Metric/Evaluation: tracked in IRAP
• UAB research personnel must complete the 4-credit requirement for initial IRB training.

1. Log in to the CITI program via UAB (use Blazer ID and UAB password): CITI Basic-Biomedical or Behavioral-Course in Human Research Protections
2. This will bring you to the CITI Program Page.
3. Select University of Alabama, Birmingham.
4. On the Institutional Courses page, click the “View Courses” button next to University of Alabama, Birmingham.
5. Click “Add a Course”
6. ​On the Select Curriculum page:

• Question 1, check the first or second option – IRB Initial Training (choose either Biomedical or Social Behavioral as indicated by your role).

7. ​At the bottom of the page, click Submit.
8. You will be brought back to the Main Menu. The course(s) you selected will be listed. Click on the course name to begin.
9. After completing the course, the Office of the IRB will be automatically notified.

Continuing IRB Training/Refresher IRB Training

• Biomedical 2018 and Social/Behavioral/Educational 2018 are the ONLY courses accepted for IRB refresher training at this time.
• Following completion of IRB initial training, UAB IRB policy requires refresher training once every three years for key personnel involved in human subjects research. All training courses are valid for three years from the date of training completion. A training course completed on September 26, 2017 will be valid until September 25, 2020.
• The UAB Office of the IRB has worked with the CITI Program to create different refresher training courses for (1) Biomedical and (2) Social/Behavioral/Educational researchers. Both course options contain the same elements. Complete only one course.
• Both courses require investigators to complete only 2 required modules.

1. Log in to the CITI program via UAB (use Blazer ID and UAB password): https://www.uab.edu/research/home/continuing-irb-training
2. This will bring you to the CITI Program Page.
3. Select University of Alabama, Birmingham.
4. On the Institutional Courses page, click the “View Courses” button next to University of Alabama, Birmingham.
5. Click “Add a Course”
6. On the Select Curriculum page:
   • Question 1, check the fourth or fifth option – IRB CITI Refresher Training Course (choose either Biomedical or Social/Behavioral/Educational as indicated by your role).
7. At the bottom of the page, click Submit.
8. You will be brought back to the Main Menu. The course(s) you selected will be listed. Click on the course name to begin.
9. After completing the course, the Office of the IRB will be automatically notified.

UAB has adopted a policy that all research-active faculty and staff renew basic instruction in the Responsible Conduct of Research (RCR) every four years.  Many of UAB’s faculty and staff have already begun or completed the CITI course entitled “RCR – Basic Course for Faculty and Staff” and we encourage research-active faculty and staff to take the course as soon as convenient.

The course is self-paced and involves modules on the following topics: authorship, peer review, plagiarism, reproducibility, data management, and export control. The modules are informative and relevant, and the brief 5 question quizzes can be taken at any time during each module to memorialize completion.

Basic RCR Course Instructions

1. Log in to the CITI program via UAB (use Blazer ID and UAB password): Click CITI Login Page on the UAB IRB GCP Training page.
2. This will bring you the CITI Main Menu.
3. Click Add a Course.
4. On the Select Curriculum page:
   • ​​​​​​Question 1, leave blank.
   • Question 2, leave blank.
   • Question 3, check the second option, RCR – Basic Course for Faculty & Staff.
5. ​At the bottom of the page, click Submit.
6. You will be brought back to the Main Menu. The course you selected will be listed under the heading Course. Click on the course name to begin.
7. After completing the course, the Office of the IRB will be automatically notified.

• This one-session, four-hour program is offered to new employees within 2 months of hire
• Content of the course is focused on the basic flow of a research study (general information)
• Offered virtually
• Objective: to provide an overview of the language of research and a general review of the entire process of implementing a study.  Additionally, this program will provide the attendees with information about resources on campus.
• Program addresses: GCPs, roles and responsibilities, pre-study activities, during-study activities, and post-study activities
• Test at beginning and end of program to assess knowledge gain
• Audience: entire research team
• CMEs offered

• This is a 24 hour course (six 4-hr sessions over 6 weeks, offered twice annually) for research team members
• Traditionally a face to face program with classroom/didactic lectures and hands on activities – now offered virtually
• Objective: to operationalize GCP, provide contacts for mentoring, and identify resources
• CMEs offered
• Pre and post-test; daily evaluations to assess knowledge gain
• Audience: entire team with focus on research coordinators (nurse and non-nurses)
• Cost: $150 enrollment fee

• Key topics for investigators covering roles and responsibilities, informed consenting, recruitment and retention, UAB navigation, mentors, etc.
• Virtual courses with interactive activities
• Program developed with investigator input/feedback
• Objective: to operationalize GCPs
• Content is focused on the investigator’s role in study implementation
• Evaluations at the end of each program/session
• Audience: all investigators

• 2 1-hr sessions each month (first and third Thursday of each month), offered 10 months each year
• Research Grand Rounds opportunity offering interactive activities: writing budgets, completing IRB submissions, etc.
• Objective: provide opportunity for continuing education with more in depth information
• Audience: entire research team with focus on investigators, regulatory staff, research administrators and research coordinators
• CMEs frequently offered
• Evaluations at the end of each session

• A public meeting with the goal to present new and critical issues related to existing, new, and pending research processes at UAB
• Audience: entire research team, primarily coordinators, regulatory staff, data managers and administrators
• Offered quarterly (Tuesdays, 11:30am – 1pm)
• Traditionally held in Margaret Spain Auditorium, now offered virtually

 
Mastering Collaborative Research Leadership

• What: 8-week course to enhance leadership skills among clinical research team members through experiential learning

• Why: Understand fundamental concepts of leadership, interpersonal effectiveness, trust-building and teamwork 

• Who: Clinical Research Staff Professionals committed to enhancing their interpersonal and leadership skills

• Visit UAB's Learning Management System, and select the course, “Financial Conflict of Interest”
• Step 1 - training through Campus LMS: https://uab.docebosaas.com/learn
• Step 2 - Fill out Disclosure of Financial Interest Form here: http://www.uab.edu/uabforms

• Under Submit New Forms (on the left side of the page),

• • Click on External/Internal Activity Approval/Financial Interest Disclosure and the form will open.
  • Select the appropriate answer for “My Employment Classification Is”
  • Please answer “YES” to “Are you an Investigator or an Institutional Official”
  • Please select Disclosure of Financial Interest (3rd selection)

• Please answer the remaining questions and click “submit”

If you will be performing research activities at UAB entities including the Kirklin Clinic, Whitaker Clinic, UAB Hospital, or any other UAB Medicine facility, you are required to obtain traveler privileges. A traveler is defined as any person who is not employed by UAB Hospital or Health Services Foundation who comes into an ambulatory clinic setting to perform care, treatment, services, or research.  See the New Traveler Orientation Request Form for more information on how to obtain your Traveler Badge.

• Shipping Infectious Substances Category B
• Shipping with Dry Ice
• Medical Waste Management for Labs