The UCD 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|
|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.|
If you will be working in UCHealth facilities, enrolling UCHealth patients, or need access to UCHealth's electronic health record (EPIC), please fill out this enrollment form prior to attendance.
|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.
Download the class materials below prior to attending:CTSA2 Informed Consent Slides
UPDATED Resources for CTSA2
|CTRC Overview and Ht, Wt, and Vitals Competency Training (CTSA3) *ON HOLD DUE TO COVID-19*||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:
|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.|
|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.|
|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.|
|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
|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.
Download the class materials below prior to attending:
An Introduction to Budget Development for Clinical Trials (Budget1)
|This training will introduce the learner to the process of developing a budget for a clinical trial. It will cover the basic items to include in the budget, the resources available to assist with each step, and provide an overview of the related regulations and institutional requirements. |
|MCA and Billing Plans (Budget2)||The Medicare Coverage Analysis (MCA) is the national standard that indicates what can be billed to insurance within the context of a clinical trial. The MCA is necessary for compliance with Medicare and private payers and is also used to drive budget development and negotiations. This class will review the applicable regulations and how to complete an MCA.|
|Planning and Budgeting for Industry-Initiated Trials: An Overview (Budget3)||This class provides an overview of the steps and building blocks involved in developing an internal draft budget for clinical trials that are initiated by an industry sponsor. Participants will learn how to identify the costs that need to be considered when developing these budgets, and will be introduced to the process involved in obtaining pricing information, and how the billing plan is used in the process.|
|Negotiating the Industry Sponsored Clinical Trial Budget (Budget4)||This course offers beginner to intermediate information regarding how to 1) build a budget that allows flexibility for negotiation, and 2) respond to common sponsor objections during budget negotiation.|
Responsible Conduct of Research
NIH requires that all trainees, fellows, participants, and scholars receiving support through any NIH training, career development award (individual or institutional), research education grant, and dissertation research grant must receive instruction in responsible conduct of research. Responsible conduct of research is defined as the practice of scientific investigation with integrity. It involves the awareness and application of established professional norms and ethical principles in the performance of all activities related to scientific research.
Individuals who will be conducting human subjects research must first complete training in the protection of human subjects and health information privacy and security through CITIProgram.org. Instructions for how to access the CITI training and which courses to take can be found on the COMIRB website.
Training is required in order to obtain OnCore access.
Education Consultation and Small Teams/Individual training
We offer Education Consultations and customized training for study teams and individuals based on your needs. An Education Consultation can be requested at any point in the study. We can provide feedback on your study processes and documents, and give you the tools you need to keep your study running smoothly. Please contact us to get started.