Collaborative Institutional Training Initiative (CITI)
UTHSC has selected the CITI training program for clinical researcher training. CITI is a widely utilized web-based training platform that provides a variety of training courses for different aspects of clinical and non-clinical research. Human subject protections and good clinical practice courses are mandatory for clinical researchers; however, there may be additional courses required based on other research activity, e.g., responsible conduct of research, animal welfare, conflicts of interest, bio-safety, etc. These courses may be assigned through an institutional office, department or program.
Mandatory Human Subject Protections (HSP)/Good Clinical Practice (GCP) Training for New Users
UTHSC requires documented coursework for clinical researchers that meets the mandates for human subject protections (HSP) and for good clinical practices (GCP) training established by the DHHS Office of Human Research Protections (OHRP), Food and Drug Administration (FDA) and the National Institutes of Health (NIH).
Clinical Research = Human Subject Research
Clinical research can be defined is any systematic investigation conducted through an intervention or interaction with human subjects or on material of human origin such as tissues, specimens and cognitive phenomena. Types of human subject research include: (1) Patient-oriented research studies: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies. (2) Epidemiologic and behavioral studies. (3) Outcomes research and health services research.
A clinical researcher, including students and trainees, is one that engages in clinical research activities.
Clinical Researchers Training Requirements
Initial UTHSC clinical researcher training for new users in human subject protections and good clinical practices was revised and the content merged into one Basic HSP+ GCP course. This change was implemented in October 2020.
The new requirements are as follows:
- Any clinical researcher or other individual (including students and trainees) that participates in clinical research activity is required to take the basic HSP/ GCP course for clinical researchers.
- Individuals that are members of the IRB committee, IRB office staff or other appropriate institutional officials must take the basic HSP/GCP IRB course.
- Students who are not engaged in a clinical research study must take the “Student Course” to satisfy program requirements.
If you have responsibilities in more than one of these areas, you are required to take the more comprehensive training. For example, if you are a clinical investigator and a member of the IRB committee, take the training for IRB members.
Please note: There are supplemental modules available to all UTHSC registered users that can provide additional information for specific topics, e.g., additional protections for minors, prisoners, FERPA, etc. These modules are listed as supplemental under the required modules in the basic HSP +GCP courses.
Re-certification training for HSP+ GCP is required every three years. Recertification is now accomplished by testing out. Failure to obtain a passing score of greater than or equal to 85% on the test will result in you being directed to re-take the basic HSP +GCP course. You must pass the test on the first try.
Retain your CITI username and password for all future access. DO NOT create duplicate accounts. If you have forgotten your user name or password, you may request your login and/or password information by selecting the appropriate link on the CITI login page.
Please use only your UT institutional email address for registration in CITI rather than a personal email. This will facilitate identification of your learning records and will allow tracking within the institution.
The minimum passing score has been set at >85% for initial and recertification training. When taking the course, if you desire to improve a quiz score at the end of a module, you may re-examine the course material and repeat the quiz until you are satisfied with your score. When testing out, you must attain a passing score or re-take the course.
Documentation of Training
Once you have successfully completed your training, you are responsible for maintaining a record of completion. A completion report and or/ certificate is available and accessible to you and can be printed at any time from the CITI website.
The University of Miami, School of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACGME) to sponsor continuing medical education (CME) activities. There is a handling fee for a CME credit letter. Please see details on the CITI website.
Frequently Asked Questions
- How long does it take to complete this training?Each module may take from 10 –20 minutes depending on the knowledge and experience of the learner. The learner may take more than one session to complete the training. The course software will track the participant’s completed modules and save any module completions. (To move forward the quiz must be completed.)
- Is there a re-certification requirement for HSP/GCP training?Yes. UTHSC requires all clinical researchers and staff re-certify every three years for both HSP and GCP training.
- What if I have completed the previous courses for HSP (e.g. Groups 1, 3, etc.) and/or GCP?Group designations are no longer valid. You will be directed to appropriate refresher content based on your initial training. Failure to obtain a passing score on the Quiz will require completion of the initial HSP /GCP course completed.
- What should I know about the module quizzes?Upon completion of each training module within a course, the user will be prompted to complete a short quiz. The software will grade the quiz and collate the scores. You may re-read any module and repeat the exam until you are satisfied with the score. The grade book and the completion report will reflect only your best score. (A few selected modules do not require a quiz.)
- How important is the member profile information?This information is critical to the accuracy and tracking of your training documentation. Your CITI profile information, especially your name and email, is used to link your training record with the tracking database. Inaccurate profile information can slow down and/or halt the submission process for research projects while documentation of training is located. Learners can update Member profile information at any time. Common reasons to update your profile include: name changes, a department change and email address changes.
- Are notification sent when it is time to re-certify my training?Yes, you will receive a notification from CITI 30 days prior to your training expiration. This notification will be sent to the email address you have listed in your CITI member profile. Remember: Use your UT email address for registration of your CITI account.
- What if I have taken HSP and GCP training at another institution?If researchers new to UTHSC have taken Human Subjects Protections and Good Clinical Practice training at another institution, their certificates will be reviewed for reciprocity. If the coursework is comparable, UTHSC will accept their training. If the coursework is not comparable, researchers may test out as an option or additional modules may be assigned as needed.