Basic Level Courses
|Combined Orientation for Research Professionals (CTSA1)
||This training will convey relevant and basic information related to the conduct of human subjects research at the University of Colorado Denver, Anschutz Medical Campus, and University of Colorado Health to create new research professionals who are better informed of not only the potential requirements of their new position, the requirements for the conduct of human subjects research, but also the resources available to them.
|Informed Consent: Overview of a Process (CTSA2)
||This course will take the student through the step-by-step process of obtaining subject informed consent. This includes discussing the elements of informed consent, documenting the informed consent process, and ensuring proper informed consent processes can be followed. There will be hands-on training on writing the consent form and tips for making it the best it can be. Discussion of vulnerable population consent will also be included.
|CTRC Overview and Ht, Wt, and Vitals Competency Training (CTSA3)
||In this course, attendees will observe the correct methods for obtaining height, weight, and vital signs (blood pressure, temperature, pulse, and respirations) from adult patients. Attendees can also participate in a walking tour of both the inpatient and outpatient UCH CTRCs. The tour will include an overview of the process for scheduling patients; where specific CTRC patient procedures take place (e.g., blood collection, ECHO, and EKG); and coordinator work space in the clinic.
|Overview of Human Subject Regulations (CTSA6)
||This training will provide an introduction to human subjects research regulations; the differences between Exempt, Expedited, and Full Board reviews; and an introduction to human subject research involving vulnerable populations.
|COMIRB’s Beginners Guide to eRA (InfoEd): Basic Navigation and Submission Process (CTSA33)
||This course is aimed towards those who have never used InfoEd, and will cover basics such as: |
• Logging In
• Editing your profile
• Basic navigation
• Submitting protocols
|UCHealth Research Policy Review (CTSA35)
||Do you want to know how UCHealth upholds federal regulations regarding human participant research? Come learn about and discuss UCHealth’s research-related policies! This class will require you to review UCHealth’s research-related policies (click that hyperlink to find them) prior to class.
Intermediate Level Courses
|Submitting an Initial Application to the COMIRB (CTSA8)
||In this training, participants will learn step-by-step instructions for filling out the COMIRB application and the attachments.
|Reporting to the IRB - Requirements After Initial Approval (CTSA10)
||This training will review the reporting requirements of the PI once the study has been initially approved by COMIRB. It will cover the reasons and timeframes for reporting, including unanticipated problems, adverse events, noncompliance, amendments, continuing reviews, and study closures.
|Recruitment and Retention of Study Subjects (CTSA11)
This training will cover the steps involved in recruitment, discuss national studies that have had high enrollment and retention rates, and the regulations surrounding recruitment. Also included will be a section on recruiting protected and special populations.
|External IRB Oversight - UCD Requirements and Processes (CTSA30)
||This course provides an overview of the UCD’s requirements and processes when an external IRB will provide regulatory oversight for a research study. Attendees will learn the steps of the submission process, including how InfoEd, the Human Subject Research (HSR) Portal and reviews of the External IRB Coordinators in the University’s Office of Regulatory Compliance come together, and the responsibilities of the research team. The course will also provide instruction on the processes for subsequent study changes after initial approval.
||This course will provide an overview of the ClinicalTrials.gov system including requirements for posting a trial, common mistakes when posting and continuing responsibilities.
|Additional Considerations for Subpopulations (CTSA36)
||In this class, students will learn to:|
1) define and discuss the term which populations require additional considerations with regard to human subjects research;
2) understand the ethical considerations relevant to research with these populations;
3) understand existing U.S. regulations and multinational guidelines that govern research with these populations, and
4) explain how research with these populations can be conducted ethically and be of benefit to those populations.
Advanced Level Courses
|Collaborative Research when the COMIRB is the IRB of Record (CTSA27)
||This course will discuss the types of collaborations that most frequently occur and regulatory issues to
consider, including the the definition of site "engagement," the use of
IRB Authorization Agreements (IAAs) and Individual Investigator
Agreements (IIAs), and the process for ceding to COMIRB.|
|Protocol Development for Faculty and Researchers (CTSA32)
||This series of six hands-on
sessions, over 7 weeks, emphasizes facilitated learner interaction supported by
didactic discussions. The workshop guides learners through the development of
key sections of a human subject research protocol. Through homework assignments,
learners should have a completed protocol ready for SARC and/or COMIRB
submission by the end of the series.|
Protocol Development Resources
Protocol Writing for Human Subject Research (CTSA34)
||This lecture provides an overview of protocol writing and development for investigators conducting human subject research. Topics covered include protocol purpose, audience-appropriate communication through writing, scientific design, and protocol organization with a content discussion of each protocol section.|
Protocol Development Resources