How will this policy be enforced? What will happen if an investigator or associated research staff member does not complete CITI education?

• This requirement will be monitored by the Human Subject Protections Office (HSPO) and IRB administrative staff as new, continuing review protocols and amendments to new study staff are submitted to the office.  All study staff listed on the protocol must have completed the exam with an 80 percent or greater passing grade. 

• Final IRB approval will not be granted until the requirement has been met. 

How do I register for training?

Instructions for taking/registering for the CITI exam:

1. Go to http://www.citiprogram.org

2. Under the “New Users” section, click on “Register Here”

3. Select your Participating Institution as “Beth Israel Deaconess Medical Center”

1. Select your User Name [provide your BIDMC e-mail address, if you have one, e.g.: jsmith@bidmc.harvard.edu] and Password You may take the CITI training if you do not have a BIDMC e-mail address, however, please be aware that if you do not have a BIDMC e-mail address/login you will not show up on our internal database as having completed CITI training. We encourage you to obtain a BIDMC e-mail address/login so that your test results may be readily available to others who may need to verify your completion of the exam. You may contact your Department Administrator in order to obtain a BIDMC e-mail address /login.

2. Provide Name and E-mail address

3. Complete CITI Registration Page. [note * required fields].  Choose "Basic Human Subjects - Biomedical Basic Human Subjects" as the course that you plan to take.  Click Submit.

4. You will then be directed to the Enrollment page and will be presented with a series of questions or options to enable you to enroll in the Learner Group appropriate to your role in human subject’s research.

5. After you submit, you will be given the opportunity to affiliate with a VA Medical Center.  Answer "NO" and Submit.

6. The next page is the “Learner's Menu”.  This page lists the courses that you will need to complete.  You will see the list of training(s) under “My Courses”.  The link (Enter or Re-Enter) will permit you to Begin/Continue the Course.

7. Complete ALL of the Course modules by reading each module text and taking quizzes.  The minimum "passing" aggregate score for the quizzes is 80%.  If you did not pass the quiz, you may repeat any quiz. 

8. Print or download a Course Completion Report as evidence that you have met your institutional requirements.  A copy will be sent automatically to HSPO Education administrator and your name and completion date will be posted on the BIDMC Web Based Training and Exam Certification Listing.  You may return to the course site in the future to obtain a copy of the completion report and/or to complete additional trainings, as necessary.

• The following groups are available to different individuals in the research field:

Group 1- Basic Required Training for Investigator and Research Staff 
 This group is required for those who are involved in the design and/or conduct of the research, have access to human participants, and/or confidential and identifying information.

Group 2- Basic Required IRB Member/Staff Training
 This group is required for all IRB Members, Administrators, Coordinators and Staff members.

Group 3- Basic Refresher Course
 This group is required for those Investigators and Research Staff conducting clinical trials that have not completed the Basic Human Subjects Protection required training in the past three years.

Group 4- Good Clinical Practice
This group is required for all Investigators that are the holder of an Investigational New Drug (IND) or Investigational Device Exemption (IDE)
This group has also been established as an optional course for those Investigators and Research Staff conducting clinical trials.  It is strongly recommended for those Investigators and Research Staff participating in FDA regulated research involving a drug, device or biologic that may undergo an FDA audit.

How long does it take to complete the exam?  Can I complete this training in several sessions?

• The Basic training will take approximately 4-6 hours to complete.  The refresher course takes approximately 1-2 hours to complete.

• Yes, you can leave and come back to the site using your CITI username and password.  You are encouraged to use multiple log on sessions. Please Note: Registrants who begin the course but do not log in again for 30 days will be deleted from the system and will have to re-register.

·         If you have taken the exam in the past three years then you will need to affiliate with BIDMC and complete the BIDMC specific modules.  Follow these steps:

1. Go to www.citiprogram.org and log in with your Username and Password

2. Once you are on the main page, click on the link that says Affiliate with another institution

3. In the “Participating Institutions” drop down box, choose “Beth Israel Deaconess Medical Center” and click “Submit”

4. Fill out the appropriate information and click “Submit”

5. Once you return to the main page you will also need to change your Username to your BIDMC e-mail address (e.g. jsmith@bidmc.harvard.edu).

 ·         If there is an issue with your completion report transferring over to BIDMC, please contact Michael D'Egidio, Human Subject Protections Office, Research Education Administrator at CITIexam@bidmc.harvard.edu

 ·         If you have taken the exam, but not in the past three years then you will need to affiliate with BIDMC (follow the instructions above) and complete the Group 3-Basic Refresher Course in order to fulfill the Continuing Education Requirement.

• Yes.  The Refresher Course must be completed every three years.

• Yes, the database will be available as it was for the RCR exam through the BIDMC Web Based Exam Certification Listing, which can be found at http://research.bidmc.harvard.edu/Data/quizcertified.asp

Do you accept any other exams for BIDMC researchers?

• Compliance training received at other meetings or institutions will be accepted on a case-by-case basis when the request for approval is received from the Investigator in writing along with a course outline and letter or certificate of course completion from the referenced program. 

What do I do if I have forgotten my username or password?

• CITI has an automated username and password retrieval system available at http://www.citiprogram.org/emaillogin.asp.  If you encounter problems retrieving this information, contact CITI Support at (305) 243-7970.

• To continue with the current practice, we will accept the Subcontractor’s/Collaborator’s training from their corresponding institution.

• If Subcontractor’s/Collaborator’s research personnel have completed the CITI exam at another institution, they will need to follow the instructions above for how to affiliate with BIDMC through the CITI exam website. 

• If the Subcontractor’s/Collaborator’s research personnel are not affiliated with an institution the individual will be required to take the CITI exam. Please contact your Department Administrator at BIDMC.

Does CITI offer CME/CEU credit?

• The University of Miami will provide a Continuing Medical Education credits for Physicians, Physician's Assistants, Nurse Practitioners, Psychologists and other health care providers. See the CITI web-site for more information https://www.citiprogram.org/citidocuments/cme/index.htm.

• As indicated in the NIH Frequently Asked Questions for Human Subjects Education, NIH does not endorse any specific
  programs for human subject's education. It is up to the institution to determine what training fulfills the NIH
  requirement. The Basic Human Subjects CITI training allows investigators to earn a certificate in human subject's
  protections that will fulfill the NIH requirement. Please note that the NIH may have a study specific training
  requirement and you should double check with your NIH representative.

• For any questions or concerns, please contact Michael D'Egidio, Human Subject Protections Office, Research Education Administrator at CITIexam@bidmc.harvard.edu.