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Training and Submission

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Email: IRB@eamc.org

Email: research@eamc.org

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For IRB Members

Training

Required Training

East Alabama Medical Center (EAMC) has chosen to subscribe to the Collaborative Institutional Training Initiative Program (CITI) for all of its online based human research training. All researchers who are engaged in human research must complete and education program on ethics and procedures for the use of human subjects research from CITI BEFORE the IRB may review a submission. Proof of completion for all researchers listed on a study is required at time of application submission to the IRB.

Click the boxes below for resources related to each step of the human research process.

Login Procedures for Completing CITI training for East Alabama Health

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CITI Registration and FAQs

Access CITI registration information and FAQs. 

Clinical Research

If you will be conducting a clinical trial or clinical research, please complete the applicable course(s) below for Good Clinical Practice.

The Social and Behavioral Research course (S&BR) relates to studies on sociological, psychological, anthropological, or educational investigations including observational and survey research and work with population and/or epidemiological studies. There are also specific S&BR courses if your research involves children, foreign countries (international), internet (any delivery of intervention or collection of research data/information online), pregnant women, or prisoners. The Biomedical Research course would apply for medical, physiological, or pharmacological studies. Note: if you become involved in more than one project and the population or procedures are different, you may be required to take additional courses):

  • Social & Behavioral Research
  • Social & Behavioral Research – Children*
  • Social & Behavioral Research – International*
  • Social & Behavioral Research – Children & International*
  • Social & Behavioral Research – Internet*
  • Social & Behavioral Research – Pregnant Women*
  • Social & Behavioral Research – Prisoners*
  • Bio-Medical Research

*These courses contain additional modules that are also available in the Optional Modules section of any completed course. However, if you just take the module (e.g., Internet Research) through the Optional Modules section, the completion record in the IRB portal will not reflect that you have completed the Social & Behavioral Internet Research course and you will be asked to provide a screenshot of your completion (for each project submission to which it might apply.) We strongly recommend adding the course in CITI so that the completion record in the IRB portal will reflect the additional coursework.

EAMC IRB requires completion of Good Clinical Practice training, Refresher training is required every three years.

  • Basic GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
  • Basic GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)
  • GCP - Social and Behavioral Research Best Practices for Clinical Research

Training for research involving access or use of protected health records or that is otherwise subject to HIPAA is included in the Biomedical Research basic course and all of the Biomedical Research Refresher Courses. It is also available through optional modules in the Social & Behavioral Research courses. Once any of the Social & Behavioral Research courses are complete, Optional Modules can be accessed by opening the course in CITI. Find a HIPAA-related optional module. You are looking for Research and HIPAA Privacy Protections (ID14), Biomed Refresher 1 – Research and HIPAA Privacy Protections (ID 17261), Biomed Refresher 2 – HIPAA and Human Subjects Research (ID 526), or Biomed Refresher 3 – Research and HIPAA Privacy Protections (ID 17265). Ideally, CITI should present all of the optional modules but if it doesn’t, select ID 14 or the Refresher module in order they are presented here (1, 2, then 3).

The IRB can only determine that the HIPAA training is complete if the Biomedical Course is complete. If you take the optional module in addition to a completed Social Behavioral research course, you will need to provide a copy of your completion certificate in your submission.