Classes and Courses

The CU Denver | Anschutz Clinical Research Training & Education Program offers many courses on all aspects of conducting research with human participants. These courses are offered year-round, repeat often, and are taught by experts in their field. Registration for these courses is recommended, but not required.

Basic Level Courses
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.

Register for an upcoming session.

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 coordination work space in the clinic.

Register for an upcoming session.

Note: If you need to take vitals for pediatric participants, please enroll in CHCO's Pediatric Vitals Training instead of CTSA3.

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.

Register for an upcoming session.

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
  • Delegation
  • Basic navigation
  • Submitting protocols

Register for an upcoming session.

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.

Register for an upcoming session.

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.

Register for an upcoming session.

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.

Register for an upcoming session.

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 is currently on hold.

ClinicalTrials.gov (CTSA31)

This course will provide an overview of the ClinicalTrials.gov system including requirements for posting a trial, common mistakes when posting and continuing responsibilities.

Register for an upcoming session.

Secondary Research (CTSA37)

This training provides an introduction to secondary research, including how to prepare documents for COMIRB review. Time will be reserved to discuss your secondary research projects.

Register for an upcoming session.

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 definition of site "engagement," the use of IRB Authorization Agreements (IAAs) and Individual Investigator Agreements (IIAs), and the process for ceding to COMIRB.

Register for an upcoming session.

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.

View Protocol Development Resources.

This workshop is offered quarterly. Watch the Clinical Research Support Center newsletter for dates.

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.

Register for an upcoming session.

View Protocol Development Resources.

CAPA: Corrective and Preventive Action Plans in Clinical Research (CTSA38)

In this course, participants will learn the process for developing an effective Corrective and Preventive Action Plan (CAPA). It will cover when and why CAPAs are needed, ways to identify a root cause, and tools to facilitate the process.

Register for an upcoming session.

Download the class materials below prior to attending: