MCW Certification Program - CITI
MCW requires all individuals involved in the design, conduct or review of human subjects research to have current certification of Human Subject Research Protections (HSRP) training. MCW provides HSRP training via the Collaborative Institutional Training Initiative (CITI).
Collaborative Institutional Training Initiative, CITI
MCW requires individuals involved in the design, conduct or review of human subject research to have current Human Subject Research Protections training. MCW utilizes the CITI Program to provide Human Subject Research Protections training for biomedical researchers, social/behavioral researchers and research reviewers.
- Everyone involved in the design, conduct, or review of human research carried out by MCW faculty investigators at any location or reviewed by MCW IRBs or another authorized IRB must obtain CITI certification.
- New employees must complete the required modules and obtain CITI certification prior to starting any human subject research work.
- Members of the human subject research team, including the Principal Investigator (PI), must have current certification.
Initial CITI certification is obtained by completing the required online modules and one elective module with an overall score of 80%. The initial CITI course can be completed in four to six hours. Six CE credits are available from CITI for purchasing by the individual.
In order to maintain CITI certification, everyone is required to complete the CITI Refresher course every three (3) years after initial certification is obtained. Completion of the refresher modules can usually be completed in less than two hours.
MCW offers Human Subject Research Protections training for biomedical researchers and social/behavioral researchers in CITI. Individuals are encouraged to select the CITI course that best aligns with the type of research being conducted, biomedical research or social/behavioral research. CITI Courses and Types of Research contains information to assist in the selection process.
CITI Courses and Types of Research
MCW offers Human Subject Research Protections (HSRP) training for both the biomedical researcher and the social/behavioral researcher. A brief description of the CITI courses that meet MCW's HSRP training requirements are provided to assist in the selection of the applicable course.
Biomedical involves all types of clinical research studies, including FDA-regulated research and those that involve investigational drugs, biologics, and devices.
- Investigational devices encompass a wide variety of items. The following are examples which would be considered investigational devices:
- Non-FDA cleared devices (both implantable or one which will be applied to just the surface of the body)
- Investigational software packages which will be run on a FDA cleared device (such as WIP MR pulse sequences, or post-processing analysis software);
- In-vitro diagnostic assays (IVD), laboratory developed tests (LDTs);
- Certain types of mobile applications which will provide a clinical decision (without physician or provider input)
This course combines the Biomedical Research course along with the Good Clinical Practices (US FDA focus) course.
Completion of this course allows Investigators to seamlessly complete both courses and will ensure that these trainings and certifications are renewed every 3 years. Completion of this course will assist Investigators and research study staff in complying with Sponsor, or MCW departmental/division research requirements.
Social/Behavioral Research (SBR) encompasses a wide variety of research including but not limited to:
- Survey research,
- Epidemiological studies
This research does not involve any drugs or devices (investigational or market-approved).
This course is listed as Social/Behavioral Learner Group.
Individuals who complete this course may also be interested in completing the CITI course Good clinical Practices for Social Behavioral Research.
The Advancing a Healthier Wisconsin Endowment, stewarded by the Medical College of Wisconsin, has a mission to work with partners to serve as a catalyst for positive change in the health of Wisconsin communities.
This course is listed as Group 6: Healthier Wisconsin Partnerships Community members. The course is designed to focus on the unique aspects to consider and be aware of in the conduct of human subject research based in the community. This course is MCW's HSRP training for community partners participating in the conduct of human subject research.
Please note: Completion of this course will not fulfill the HSRP training requirements for MCW IRB for MCW/FH faculty, staff or students engaged in the conduct of human subjects research.
Frequently Asked Questions Regarding CITI
Please review the information posted here addressing the frequently asked questions concerning CITI. For additional assistance email _HSRPtraining@mcw.edu
- The recorded first and last name in the CITI Program and eBridge accounts are not the identical. To correct this, update your CITI Program account information to reflect your name as documented in eBridge; see "How do I update my name/email address?" for further instruction.
- The email address listed in eBridge differs from the preferred email address listed with CITI Program. To correct this, update your CITI Program account information to reflect your email address as documented in eBridge; see "How do I update my name/email address?" for further instruction.
- There is more than one CITI Program account associated with an individual's name. To correct this please contact HSRPtraining@mcw.edu and request that your accounts be merged.
- You have not completed the affiliation of CITI Program training with the Medical College of Wisconsin. To correct this, please complete the process as described in "How do I add MCW/change my affiliated institution or transfer my completions?".
- If you are involved in human subject research at either Children’s Hospital of Wisconsin, or the Zablocki Veterans Administration Medical Center and are current in your human subject protection training, MCW will accept this training.
- If you have completed human subject protection training at an institution other than Children’s Hospital of Wisconsin or the Zablocki Veterans Administration Medical Center and request MCW acceptance of the training, please contact HSRPtraining@mcw.edu.
- For projects where MCW is serving as the IRB of Record for another institution outside of MCW, FH or BCW, the MCW HRPP office may accept human subject research protections training from another institution provided either of the following conditions are met:
- The institution has current AAHRPP accreditation, or
- The institution is a part of a CTSA-awarded consortium
2.Enter username & password.
3.Click on "My Profiles" then click on the applicable link ("Change my name", "Change my email address").
4.Enter the updated information click on "Update".
1.Go to www.citiprogram.org.
2.Enter username and password used to register with CITI Program.
3.On the Main Menu page, click on the course title to begin or continue the coursework.
4.Complete the Integrity Assurance Statement.
5.Complete the required modules and associated quizzes and one elective module and quiz. You may re-review the modules and repeat any quizzes to attain the overall passing score of 80%. (Once you have completed all of the required modules in your curriculum you will be shown optional modules which may be completed at a future time).
6.Upon successful completion of the modules and associated quizzes print a copy of your completion report for your records.
1.Go to www.citiprogram.org.
2.Enter username & password used to register with CITI at previous or other institution.
3.On the Main Menu page, click on "My Profiles" to edit or change your email address as needed.
4.On the Main Menu page, click on the link “Affiliate with Another Institution”. Enter "Medical College of Wisconsin" (MCW) as your organization and click on "Next".
5.Provide the requested information for MCW's registration questions.
6.Enroll in the course - human subject research and select the Learner Group that most closely matches your role and type of research; Biomedical Learner Group, Biomedical research and Good clinical Practices or Social Behavioral Learner Group.
7.On the Main Menu page in the section "My Learner Tools for Medical College of Wisconsin" Click "View Previously Completed Coursework" and verify previous CITI completed modules are displayed. (To receive credit for modules previously completed you must be affiliated with both institutions; enroll in the course that needs to be transferred via "Add a Course" link for MCW and select the applicable Learner Group. Once you are enrolled in the course, any modules that are shared between the institutions will have their credit transferred automatically. The transfer is based upon the module's unique ID number. Each institution determines the timeframe in which modules are transferable, some institutions do not allow modules to transfer. )
8.On the Main Menu page you will see the selected Learner Group for MCW and status of "Not Started" or "Incomplete".
9.Click on the Learner Group to see the list of the required modules for MCW; complete the incomplete modules and associated quizzes. In addition to completing the required modules you must also complete one elective module and quiz.
Please note: Institutions choose from a wide variety of modules and overlap with MCW modules will vary. All modules required for MCW certification must be completed.
1.Go to www.citiprogram.org and click on the "Register" button located on the right-hand side of the page.
2.Enter "Medical College of Wisconsin" as your organization and click on "Continue"
3.Enter your first and last name and email address and click on "Continue". (Recommendation - list your first and last name and email address as listed in your eBridge account and consider including a secondary email address)
4.Choose a username and password for your CITI account following the instructions for each field; you must also select and answer a security question and click on "Continue".
5.Provide information regarding gender, ethnicity and race and click on "Continue".
6.Provide information regarding CE credits and completion of surveys and click on "Continue". CE credits are available for purchasing by the individual.
7.Provide the required information for the Medical College of Wisconsin as identified by the *.
8.Select the CITI course that most closely matches your research and your role in research; choose from Biomedical Learner Group, Biomedical Research and Good Clinical Practices, Social Behavioral Learner Group or Group 6: Healthier Wisconsin Partnerships Community Members and click on "Next".
1.Go to www.citiprogram.org
2.Enter username & password
3.On the Main Menu page your current Learner Group is listed under Course. To change your learner group click on “Add a Course" located in the section "My Learner Tools for Medical College of Wisconsin".
4.Select the Learner Group that most closely matches your role and type of research (Biomedical Learner Group, Biomedical Research and Good clinical Practices, Social Behavioral Learner Group, or Group 6: Healthier Wisconsin Partnerships Community Members) and click on "Next".
5.Indicate whether you will be completing the initial course or refresher course for that Learner Group and click on "Submit".
6.On the Main Menu page Under “Course” you should see a the status for the course (Not Started or Incomplete)
7.Click on the Course link and begin course work for modules which still require to be completed for the new Learner Group which was selected.
8.On the Main Menu page in the section "My Learner Tools for Medical College of Wisconsin" click "View Previously Completed Coursework" and verify previous CITI completed modules are displayed.
1.Go to www.citiprogram.org.
2.Enter username & password.
3.Click on "Remove Affiliation" found in the section "My Learner Tools for Medical College of Wisconsin".
Removing your affiliation will also remove access to completion report records for this institution
The total time is approximately 4 to 6 hours for the basic course and less than 2 hours for the refresher course.
You may complete it multiple sittings.
The certification program is web-based and can be accessed from any computer via the internet.
Good Clinical Practices Training
The NIH and its Institutes recognize that translation of novel drugs and devices requires a well-trained research workforce. The National Center for Advancing Translational Science (NCATS) as part of its mission to improve the quality of clinical and translational research nationally has initiated a series of innovative programs that make Clinical and Translational Science Award hubs and partner organizations great places to conduct high quality research. The leadership at the Medical College of Wisconsin and the Clinical and Translational Science Institute of Southeast Wisconsin (CTSI), embrace these high standards and training for our researchers. We believe that the addition of Good Clinical Practice (GCP) training will equip study personnel with the necessary and fundamental competencies to conduct FDA regulated clinical research.
MCW offers Good Clinical Practices (GCP) courses through Collaborative Institutional Training Initiative (CITI); Good Clinical Practice course (US FDA focus) and GCP-Social and Behavioral Research Best Practices for Clinical Research.
MCW requires MCW faculty and staff engaged in FDA regulated research that fit the following criteria to complete GCP training.
- Studies that involve the use of any drug or biologic therapy (including botanicals, dietary supplements, medical foods, etc.) for purposes other than routine clinical care (including physiological challenge tests).
- Safety or efficacy evaluations of any apparatus that the FDA does or might consider to be a “medical device.
- Safety or efficacy evaluation of any type of diagnostic test (including “in vitro” diagnostic tests, or “companion” / “complementary” (usually genetic) diagnostic tests).
- Any study where the results will be submitted at a later date to the FDA in support of some drug, biologic, medical device, or in vitro diagnostic test application.
- CTSI‐funded studies including Translational Research Unit and Imaging Center studies that are FDA regulated.
- Protocols submitted to IRB that used CTSI Biostatistics Research Design consultation that are FDA regulated.
Completion of GCP training may require three - six hours.
The NIH requires a 3‐year refresher of GCP training.
In case of questions regarding GCP training, please contact Amit Gode at email@example.com or at (414) 805-6999.
GCP training by the Association of Clinical Research Professionals (ACRP) or from other accredited sources including industry based programs during the past three years is an acceptable alternative to CITI GCP training. Please provide documentation of the organization providing training, topics covered, hours to complete it, and contact person at the organization to Amit Gode at firstname.lastname@example.org.