For investigators planning to conduct human participant research How to Take Collaborative Institutional Training Initiative (CITI) Online Courses www.citiprogram.org For investigators planning to conduct human participant research September 2017 Version 1.0

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1 Enter Charles Drew University of Medicine and Science Read 2 3

1 2 3 4 Provide non-institutional e-mail (gmail, aol, hotmail, etc.) Provide alternate e-mail, in case the e-mail above becomes inactive 4

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Read Institutional Review Board (IRB) does not require CEU credit to satisfy the Human Subject Research training requirement. You need only to attach the completion report for the required courses. There are no fees required to take CITI online course as long as you register under Charles Drew University of Medicine and Science. 1 Chose “yes” or “no” for Continuing Education Unit (CEU). CEU requires fee.

Choose only if you picked yes to CEU in previous question Choose only if you picked yes to CEU in previous question. Otherwise leave blank. 2 3 4

1 2 3 4 5 6 7 Blank Clinical Researcher Co-Investigator Compliance Officer Data Manager IACUC Administrator IACUC Chair IACUC Member Institutional Official Interviewer IRB Administrator Research Assistant Research Fellow – Post Graduate Research Integrity Officer Site Coordinator Social Worker Statistician Student Researcher – Graduate Level Student Researcher – Undergraduate Study Coordinator Study Nurse Veterinarian Primary CDU e-mail or alternate e-mail 3 4 5 Leave blank 6 Type “Research” if you do not belong to a department 7

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1 2 3 4 Registering for the Courses This is the Human Subjects Research “Basic Course” that should be taken the first time. For Human Subjects Research (HSR) Course in Question 1, choose either Basic Biomedical or Social-Behavioral Research Investigators, Staff, and Students. The certificate is valid for 3 years. 3 If the researcher is planning to do research involving Biomedical Data or Specimens Only, select this Learner Group instead. No interaction or intervention with research participants. 4

1 You must also take the HIPS Course, if you plan to conduct human participant research. Selection of HIPS Course is under Question 3. 2 Choose one of the Learner Groups

Additional or alternate courses that may need to be taken… Refresher Course for Human Subject Research (only after Basic Course) Good Clinical Practice (GCP) Course Conflict of Interest (COI) Course

Already took the Basic Course for Human Subject Research Already took the Basic Course for Human Subject Research? Take the “Refresher Course” instead… Please do not take the “Refresher Course” first if you never took the Basic Course

The Human Subjects Research “Refresher Course” follows the “Basic Course”. Select and take the Refresher 1 Course before the basic course expires. Start with Refresher 1 Course. After 3 years, take Refresher 2 Course. This is followed by Refresher 3 Course. If Refresher 3 Course is not available, go back to Question 1 and take “Basic Course” over again. Completion report for each refresher courses are valid for 3 years. Refresher courses are available for Biomedical Research, Social & Behavioral Research, and Biomedical Data and Specimens Only Learner Groups. 1 If you are taking “Basic Course” under Question 1, you must check this radial button, in order to proceed to the next page.

Are you planning to conduct clinical research or clinical trial involving FDA regulated products (drugs, devices)? Take the Good Clinical Practice (GCP) Course also…

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If your human participant research is supported by federal funding (e If your human participant research is supported by federal funding (e.g., NIH), do you (PI or key personnel) have a current Conflict of Interest (COI) training certificate? Yes, my COI training certificate is current. This is my first federally funded study. I need to take COI training. My COI training certificate is about to expire. Check off “not at this time” for CITI Conflict of Interest Course Take the CITI Conflict of Interest Basic Course Take the CITI Conflict of Interest Refresher Course

1 2 You must choose at least one answer

No need to choose any of the radial buttons under Question 8. To complete the registration process and to upload the course work, go to the bottom of the page (after Question 8) and click on “Complete Registration”. No need to choose any of the radial buttons under Question 8. 1 Almost done!

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This is the screen shot of your Main Menu with the Uploaded Courses HIPS Course, Required Human Subject Research (HSR) Course, Required GCP Course, May be Required COI Course, May be Required Be careful, Responsible Conduct of Research (RCR) is not the same as Human Subject Research Course and is not required by the IRB. RCR Course is selected under Question 5.

Click HIPS Course HSR Course

You will not be able to open the modules below, if you do not complete The Integrity Assurance Statement first. Click on the blue bar. Click

Your name: Read 1 2

At the end of this course, you will need to score at least 80% or above on all the quizzes to obtain a completion report. Complete all 7 required modules Complete 4 out of 9 available elective modules

Once you have passed the course, the Menu and Course page might look like this… 28-Jun-2017 View-Print-Share Post-course evaluation HIPS Course After completing the course(s), CITI will generate a completion report. Keep this for your record. You will need to attach the report to the IRB submission materials.

What additional information can you obtain from the Main Menu?

Click either one to see previously completed coursework Passed 28-Jun-2017 View-Print-Share Post-course evaluation Click either one to see previously completed coursework

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Passed 28-Jun-2017 View-Print-Share Post-course evaluation You can add refresher or other subject matter courses at a later time by selecting “Add a Course”.

CITI Courses Offered through CDU Does this page look familiar? You can add any courses (Questions 1-8) or choose a different Learner Group from the same course. CITI Courses Offered through CDU Question 1: Human Subject Research, Basic Course Question 2: Human Subject Research, Refresher Courses Question 3: Health Information Privacy & Security Course Question 4: Good Clinical Practice Course Question 5: Responsible Conduct of Research Course Question 6: Conflict of Interest Course Question 7: Biosafety/Biosecurity Course Question 8: Laboratory Animal Welfare Course These are different Learner Groups.

Passed 28-Jun-2017 View-Print-Share Post-course evaluation You can affiliate with another institution to find out if any of your previous CITI courses can be transferred to CDU.

Click

Type in the name of the institution/organization 1 You will then go through the registration process again (Steps 1-7) for the selected organization/institution

References: https://support.citiprogram.org/ (go to CITI Support Center) https://support.citiprogram.org/customer/portal/articles/1986734-guide-to-citi-navigation (My Learner Tools, Profiles, Reports, and CEUs) For additional questions, including login information or resetting password, please call 323-563-5902, 323-357-3649, 323-563-4966 or e-mail irb@cdrewu.edu. Thank you!