Training Requirements

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Guide: Matching Your CITI Account to Your DU SSO Account

The University of Denver requires all individuals to complete mandatory training who are investigators conducting human subjects research and their research meets the criteria for obtaining IRB approval or an IRB exemption. Principal investigators and any research staff that have direct interaction with human subjects or will collect identifying information or identifiable biospecimens must complete the appropriate training modules before an IRB determination letter will be issued for a new project or new personnel can be approved to a study protocol.

Through the Collaborative Institution Training Initiative (CITI) Program, training modules are available for DU faculty, staff, and students to offer human subjects protection training as required by the federal government and DU IRB policies. Successful completion of a DU CITI module is valid for four years, then a refresher course must be completed. To maintain valid training after four years and completed modules are expiring, refresher courses are offered on the key modules that were previously completed. There is also Conflict of Interest training intended for investigators who receive funding from a PHS agency, including the National Institutes of Health (NIH), or who are required by DU to be familiar with the PHS financial conflicts of interest regulations. This training must be completed prior to the initial receipt of funds.

  • Steps for Completing Human Subjects Protection Training

    As a new CITI user, you must first establish a username and password by registering under the University of Denver affiliation.

    As a registered CITI user, log into CITI using your DU SSO Account select "University of Denver View Courses" under "Institutional Courses"

    Step 1: Select "Learner Tools", and then select "Add a Course"

    Step 2: Answer Question 1 by selecting “Human Subjects Research” curriculum and click on "NEXT".

    Step 3: Identify your appropriate learning group (i.e., student, faculty/staff, unaffiliated investigator or Full Board Member) and click on “NEXT”. 

    Step 4: Select the type of research that will be conducted; social behavioral & educational or biomedical and click on “NEXT”.

    Step 5: Select the appropriate course to be completed; basic or refresher and click on “NEXT”.

    Step 6: Identify your proposed research options (study design) and click on “NEXT”.

    Step 7: Select the subject populations you will be working with and click on “NEXT”.

    Once you have answered all of the questions related to your research, all of the modules associated with the human subjects protection curriculum will be listed and you may select a module to begin. After you have successfully completed all of the modules in the human subjects research course, a completion report will be available to document your training. It is strongly recommended you save a copy of this report for your records. The Office of Research Integrity & Education (ORIE) staff will review and verify that all training requirements have been completed for individuals who are listed on any IRB application submitted for IRB review.

    Please note: Responsible Conduct of Research (RCR), Conflict of Interest (COI), and Good Clinical Practice (GCP) courses are separate from the human subjects research course requirement and may not be used as a substitute. 

     

  • Steps for Completing Conflict of Interest Training

    As a new CITI user, you must first establish a username and password through registering under the University of Denver affiliation.

    As a registered CITI user, log into CITI using your username and password, select "University of Denver View Courses" under "Institutional Courses"

    Step 1: Select "Learner Tools", and then select "Add a Course"

    Step 2: Answer Question 1 by selecting "Conflict of Interest" curriculum and clicking on "NEXT"

    Step 3: Select the “Research Conflict of Interest” option and click on “NEXT”.

    Step 4: All of the modules associated with the COI curriculum will be listed and you may select a module to begin.

    Once you have successfully completed all of the modules in the COI curriculum, a completion report will be available to document your training. It is strongly recommended you save a copy of this report for your records. The Office of Research Integrity & Education (ORIE) will verify that the COI training curriculum was successfully completed and it will be posted on the ORSP shared drive to allow Sponsored Programs and the IRB to verify that you have completed the required regulatory requirement for your federally funded project.

Steps for Completing Additional Training

  • Ethical Use of Human Subjects

    On the "Courses" page of your CITI account, follow these steps to choose the appropriate SBER curriculum:

    Step 1: Select "Add a Course" near the bottom of the page under "Learner Tools for University of Denver"

    Step 2: Select "Human Subjects Research (Social Behavioral Educational Research or Biomedical Research)"

    Step 3: Select one:
    a. I am a Student Investigator
    b. I am a Faculty/Staff Investigator
    c. I am an Unaffiliated Investigator
    d. I am a Full Board Member

    Step 4: Select the following:
    "Social Behavioral Education Research Investigators"

    Step 5: Select one (the Refresher Course can only be taken following the Basic Course):
    a. Social Behavioral Educational Research Investigators – Basic Course
    b. Social Behavioral Educational Research Investigators – Refresher Course

    Step 6: Select all that apply (the modules that are relevant to your project are required):
    a. Study Design: schools, internet, survey, international, etc.
    b. Subject Populations: children, prisoners, older adults, gender and sexual diversity, etc.

  • Responsible Conduct of Research

    Federally Funded Projects
    If you are receiving federal funding (National Science Foundation or National Institute of Health), you must also complete the Responsible Conduct of Research (RCR) curriculum.

    On the "Courses" page of your CITI account, follow these steps to choose the appropriate RCR curriculum:

    Step 1: Select "Add a Course" near the bottom of the page under "Learner Tools for University of Denver"

    Step 2: Select one:
    a. Social, Behavioral, Educational, and Humanities Responsible Conduct of Research Course
    b. Biomedical Responsible Conduct of Research Course
    c. Physical Science Responsible Conduct of Research Course
    d. RCR for Engineers

  • Good Clinical Practice for Clinical Trials

    Federally Funded Projects
    If you are receiving federal funding (National Science Foundation or National Institute of Health), you may be required or asked to complete the Good Clinical Practice (GCP) curriculum.

    On the "Courses" page of your CITI account, follow these steps to choose the GCP curriculum:

    Step 1: Select "Add a Course" near the bottom of the page under "Learner Tools for University of Denver"

    Step 2: Select "Good Clinical Practice"

    Step 3: Select one:
    a. Group 1: Faculty/Staff Investigators - Social and Behavioral Research - Good Clinical Practice
    b. Group 2: Faculty/Staff Investigator - Drugs and Medical Devices - Good Clinical Practice
    c. Group 3: Faculty/Staff Investigators - Devices - Good Clinical Practice

  • Protocol Registration in Clinicaltrials.gov

    On the "Courses" page of your CITI account, follow these steps to choose the Protocol Registration in Clinicaltrials.gov curriculum:

    Step 1: Select "Add a Course" near the bottom of the page under "Learner Tools for University of Denver"

    Step 2: Select "Protocol Registration and Results Summary Disclosure in ClinicalTrials.gov"

Training & Workshops

ORIE provides training workshops on navigating IRBNet, completing the IRB application and drafting consent documents.

To request a workshop or small group training session, please complete and submit a training request form to IRBAdmin@du.edu.

Download Training Request Form