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Version 8/20/2013 (CITI v08012013) Page 1 of 19 Created by Office of Regulatory Affairs and Research Compliance www.citiprogram.org HJF Required Research Training CITI Guide All HJF employees worldwide are required to complete all training assignments Contractors or Collaborators listed on a protocol or involved on a study are required to complete required CITI training prior HJF training requirements are not the same as those assigned from your worksite to beginning work on the study. (e.g. WRNMMC, NMCSD, VA, etc.). [Note: For further guidance, please read section on Navigating Multiple Institutional Gradebooks.] Special Note: HJF employees using CITI MUST choose Henry M. Jackson Foundation for the Advancement of Military Medicine as their participating institution. This ensures training completion history is accurately documented by the Office of Regulatory Affairs and Research Compliance. To access and complete your training, go to www.citiprogram.org Table of Contents New User Registration Procedures ........................................................................................................... 2 Exisiting User Procedures ......................................................................................................................... 7 Courses Offered .......................................................................................................................................... 8 Choosing Courses ...................................................................................................................................... 9 Health Information Privacy Security (HIPS/HIPAA) .................................................................................. 9 Course in the Protection of Human Research Subjects.......................................................................... 12 Good Clinical Practice ............................................................................................................................. 13 Biosafety/Biosecurity ............................................................................................................................... 13 Responsible Conduct of Research.......................................................................................................... 13 CITI US Export Controls .......................................................................................................................... 14 Conflict of Interest in Research ............................................................................................................... 14 Animal Care and Use .............................................................................................................................. 14 Printing Completion Certificates ............................................................................................................. 15 Tips & Contact Information ...................................................................................................................... 16 Navigating Multiple Institutional Gradebooks........................................................................................ 17

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Page 1: HJF Required Research Training CITI Guide · 2017-03-30 · Version 8/20/2013 (CITI v08012013) Page 1 of 19 Created by Office of Regulatory Affairs and Research Compliance HJF Required

Version 8/20/2013 (CITI v08012013) Page 1 of 19 Created by Office of Regulatory Affairs and Research Compliance www.citiprogram.org

HJF Required Research Training CITI Guide

All HJF employees worldwide are required to complete all training assignments

Contractors or Collaborators listed on a protocol or involved on a study are required to complete required CITI training prior

HJF training requirements are not the same as those assigned from your worksite

to beginning work on the study.

(e.g. WRNMMC, NMCSD, VA, etc.). [Note: For further guidance, please read section on Navigating Multiple Institutional Gradebooks.] Special Note: HJF employees using CITI MUST

choose Henry M. Jackson Foundation for the Advancement of Military Medicine as their participating institution. This ensures training completion history is accurately documented by the Office of Regulatory Affairs and Research Compliance.

To access and complete your training, go to www.citiprogram.org

Table of Contents New User Registration Procedures ........................................................................................................... 2

Exisiting User Procedures ......................................................................................................................... 7

Courses Offered .......................................................................................................................................... 8

Choosing Courses ...................................................................................................................................... 9

Health Information Privacy Security (HIPS/HIPAA) .................................................................................. 9

Course in the Protection of Human Research Subjects.......................................................................... 12

Good Clinical Practice ............................................................................................................................. 13

Biosafety/Biosecurity ............................................................................................................................... 13

Responsible Conduct of Research.......................................................................................................... 13

CITI US Export Controls .......................................................................................................................... 14

Conflict of Interest in Research ............................................................................................................... 14

Animal Care and Use .............................................................................................................................. 14

Printing Completion Certificates ............................................................................................................. 15

Tips & Contact Information ...................................................................................................................... 16

Navigating Multiple Institutional Gradebooks........................................................................................ 17

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NEW USER REGISTRATRION PROCEDURES

Create a new account by clicking Register on the home page of the CITI website (www.citiprogram.org).

CITI – Learner Registration process:

1. Select an institution, then click on Continue to Step 2:

In the first drop-down menu for Participating Institutions, choose Henry M. Jackson Foundation for the Advancement of Military Medicine and leave all other options blank.

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2. Personal Information, then click on Continue to Step 3:

Enter your First Name, Last Name, Email Address, and then Verify email address.

NOTE: Name MUST be consistent with HJF Human Resources department personnel records. You can enter a secondary email address, but it is not required.

3. Create your Username and Password, then click on Continue to Step 4:

Enter a User Name (is NOT case sensitive).

NOTE: Username MUST be the first initial of first name and complete last name. (Example: John Smith would be jsmith).

Enter your Password, and then Verify Password (is case sensitive).

Choose a Security Question, then enter your Security Answer.

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4. Gender, Ethnicity and Race, then click on Continue to Step 5:

Choose Your Gender Is, Your Ethnicity Is: (You may choose only one) and Your Race is: (You may choose more than one).

5. Are you interested in the option of receiving Continuing Education Unit (CEU) credit for completed CITI Program courses? Can CITI Program contact you at a later date regarding participating in research surveys? Then click on Continue to Step 6:

Answer all questions, as appropriate.

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6. Please provide the following information requested by Henry M. Jackson Foundation for the Advancemnt of Military Medicine, then click on Continue to Step 7:

Enter the required information where indicated with a red asterisk.

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7. What is the course that you need to take? Then, click on the Next button:

Choose the course you need to take from the list offered. Answer any questions regarding the course. You can check none and enter a course at a later time.

8. You will then be directed to the final page.

Click on Finalize Registration.

9. Open your email and look for the confirmation email from CITI.

Click on the link contained in the email to complete registration.

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EXISTING USER PROCEDURES

1. Log in with your Username and Password.

2. You will be directed to change your password.

3. Log out of CITI.

NOTE: If you choose not to do this immediately, you will be directed to the steps below at your next login.

4. Confirm my preferred or secondary email address: Verify and/or change Your preferred email address. Note: A secondary email address is optional and not required.

5. If you are not already affiliated with HJF, go to the Main Menu and click Click here to affiliate

with another institution (located along the top).

6. Select Henry M. Jackson Foundation for the Advancement of Military Medicine under Participating Institutions.

7. Answer the question(s) that follows regarding the course you are required to take, then click Submit.

NOTE: If you have more than one affiliation, make sure you complete all grade books for each affiliation that you have chosen. You will not be asked to retake any modules you have already taken as long as those modules have not expired. Please see more information about this in the section titled Navigating Multiple Institutional Gradebooks.

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COURSES OFFERED

Human Research Training: Course in the Protection of Human Research Subjects Every Three Years HIPAA Compliance Training: HIPAA for Administrative (HJF HQ)

Every Year

HIPAA for Administrative (Research sites) HIPAA for Clinical Investigators HIPAA for IT Personnel (Non-HJF HQ) HIPAA for IT Personnel (HJF HQ) HIPAA for Clinicians, RC & RA Good Clinical Practices Training: Good Clinical Practices Every Three Years Responsible Conduct of Research Training: Responsible Conduct of Research for Administrators

Every Three Years Responsible Conduct of Research for HQ Personnel Responsible Conduct of Research for Soc & Behav US Export Controls US Export Controls Every Year Biosafety - Biosecurity Training: Biosafety – Biosecurity Every Two Years Animal Care and Use Training: Animal Care and Use Every Three Years Conflicts of Interest Training: Conflicts of Interest in Research Every Four Years

Assigned by the Office of Regulatory Affairs and Research Compliance

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CHOOSING COURSES Health Information Privacy and Security (HIPS/HIPPA)

1. From the main page click on Add a Course or Update Learner Groups:

2. You will be taken to Select Curriculum - Henry M. Jackson Foundation for the Advancement

of Military Medicine, What is the course that you need to take?:

Choose Health Information Privacy and Security (HIPS/HIPAA), then click on Next

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3. You will be taken to Please make your selection below to take the Health Information Privacy and Security (HIPS/HIPAA) course: Choose your answer based on your role (if you are unsure, contact our office), then click on Next.

4. This will take you back to the main page. Under HJF’s Gradebook, click on the title of your

course.

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5. You will see a screen similar to below.

Click on Complete The Integrity Assurance Statement before beginning the course, then go through all the modules in this course.

Click here first

Course Title

M O D U L E S

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Course in the Protection of Human Research Subjects (these instructions apply to both) Biomedical and Social / Behavioral Research OR IRB Chairs

1. From the main page click on Add a Course or Update Learner Groups.

2. You will be taken to Select Curriculum - Henry M. Jackson Foundation for the Advancement of Military Medicine, What is the course that you need to take?:

Choose Course in the Protection of Human Research Subjects

3. Click on Next

4. What stage do you need to complete?:

Basic (1st time)

a. Choose “Basic”

b. Then, click on Next

c. Then select the group appropriate to your research activities to start CITI Basic

Course in the Protection of Human Research Subjects. Choose Group 1: Biomedical and social / behavioral research investigators and key personnel are required to complete all available CITI Modules.

d. If you have been assigned the “IRB Chairs” training, select this option instead.

e. Then, click on Next

Refresher (taken course before and it has not

a. If you have taken this course before and it has not expired, choose “Refresher”

expired)

b. Click on Next

c. Then select the group for which you have previously completed an institutionally approved CITI Basic Course in the Protection of Human Research Subjects. You will be enrolled in the Refresher Course for that group. Choose Group 1: Biomedical and social / behavioral research investigators and key personnel are required to complete all available CITI Modules.

d. If you have been assigned the “IRB Chairs” training, select this option instead.

e. Then, click on Next

5. This will take you back to the main page. Under HJF’s Gradebook, click on the name of the course (Group 1 – Biomedical & SBR OR IRB Chairs).

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Good Clinical Practice (GCP)

1. From the main page click on Add a Course or Update Learner Groups.

2. You will be taken to Select Curriculum - Henry M. Jackson Foundation for the Advancement of Military Medicine, “What is the course that you need to take?:

Choose Good Clinical Practice

3. Click on Next

4. This will take you back to the main page. Under HJF’s Gradebook, click on the title of your course.

Biosafety/Biosecurity

1. From the main page click on Add a Course or Update Learner Groups.

2. You will be taken to Select Curriculum - Henry M. Jackson Foundation for the Advancement of Military Medicine, What is the course that you need to take?:

Choose Biosafety/Biosecurity course

3. Click on Next

4. You will be taken to Please make your selection below to receive one of the courses in the Biosafety/Biosecurity course:

Choose all that apply.

[First time with this course? Only select Basic Biosafety Training.]

[If you only need Shipping Dangerous Goods Training, only select Shipping & Transport of Regulated Biological Materials.]

5. Click on Next

6. This will take you back to the main page. Under HJF’s Gradebook, click on the title of your course.

Responsible Conduct of Research

1. From the main page click on Add a Course or Update Learner Groups.

2. You will be taken to Select Curriculum - Henry M. Jackson Foundation for the Advancement of Military Medicine, What is the course that you need to take?:

Choose Responsible Conduct of Research

3. Click on Next

4. You will be taken to a page to Please make your selection below to receive one of the courses in the Responsible Conduct of Research.

Choose your answer based on your role

5. Click on Next

6. This will take you back to the main page. Under HJF’s Gradebook, click on the title of your course.

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CITI US Export Controls

1. From the main page click on Add a Course or Update Learner Groups.You will be taken to Select Curriculum - Henry M. Jackson Foundation for the Advancement of Military Medicine, What is the course that you need to take?:

Choose CITI US Export Controls

2. Click on Next

3. You will be taken to Please make your selection below to take the CITI US Export Controls Regulations course:

Choose CITI US Export Controls

4. Click on Next

5. This will take you back to the main page. Under HJF’s Gradebook, click on the title of your course.

Conflict of Interest in Research

1. From the main page click on Add a Course or Update Learner Groups.You will be taken to Select Curriculum - Henry M. Jackson Foundation for the Advancement of Military Medicine, What is the course that you need to take?:

Choose Conflict of Interest in Research

2. Click on Next

3. This will take you back to the main page. Under HJF’s Gradebook, click on the title of your course.

Animal Care and Use

1. From the main page click on Add a Course or Update Learner Groups.

2. You will be taken to Select Curriculum - Henry M. Jackson Foundation for the Advancement of Military Medicine, “What is the course that you need to take?:

Choose Animal Care and Use 3. Click on Next

4. You will be taken to What is the group that you belong to?:

Choose all that apply

5. Click on Next

6. You will be taken to What optional course(s) that you would like to complete?:

Choose all that apply (You MUST choose at least one)

7. Click on Next

8. This will take you back to the main page. Under HJF’s Gradebook, click on the title of your course. [Note: There may be several if you choose optional modules.]

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PRINTING COMPLETION CERTIFICATES

1. A screen similiar to below is generated at the end of the course.

2. You will be returned to the Main Menu. From there, click on Print Report.

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TIPS

Employee can choose to select an additional affiliation if the employee works at a site other than HJF headquarters. You should select HJF as your initial institution affiliation.

The course does not need to be completed at one time. You can start and stop during the course, except during a quiz. If you stop the course during a quiz, you will be locked out of the course and will need to call the HJF Office of Regulatory Affairs or CITI to have your account unlocked. You must complete all required course modules. Successful completion is a score of 75% or higher. After successful completion of the course, you may printout a completion certificate. To see a list of completed courses with expiration dates, click on View previously completed Coursework under the HJF gradebook. NOTE: It is imperative that the user selects Henry M. Jackson Foundation for the Advancement of Military Medicine as the primary institution; this will allow the institutional administrator at HJF to automatically receive notification and a copy of the employee’s completion certificate.

Contact Information for Assistance

HJF Office of Regulatory Affairs and Research Compliance

Marianne Spevak (240) 694-2067 Susan Kwon (240) 694-2142

Email: [email protected]

CITI Program Helpdesk (305) 243-7970

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NAVIGATING MULTIPLE INSTITUTIONAL GRADEBOOKS

1. So how do you know if you are affiliated with more than HJF? The number of participating institutions you are affiliated with is listed on the main menu. They are listed in blue “drop-down” sections. Clicking on any one of them will toggle the contents. The HJF gradebook is shown below.

This individual is affiliated with 3 institutions.

NOTE:

For every institution you are affiliated with, there is a corresponding grade book.

Each grade book will look like what is highlighted in pale yellow.

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2. Here are what the other grade books might look like.

They are very similar to the HJF grade book from the previous page. 3. For each grade book, you must complete the assigned courses required by the institution.

For example, this individual completed their HJF required human subjects protection training course on 2/28/2013 with the listed modules.

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4. If you have to complete the same type of course for another institution, you are not required to re-take modules that you have already taken. However, if they are expired, then you will be required to take them again.

As an example, this individual had most of their modules already completed when they took the same type of course in another institution’s grade book. The highlighted area in pale yellow are the modules that needed to be completed to satisfy this institution’s grade book.