The Clinical Research Training courses are designed to provide specialized instruction on conducting clinical research to research study coordinators and investigators. It consists of over 26 hours of content and is delivered by staff and faculty at UC Denver and affiliated institutions. While the curriculum is aimed at new investigators and coordinators, it may be recommended for investigators who are experiencing problems with COMIRB review, writing consent forms, protocol violations, or patient safety issues.

Additionally, there is a Clinical Research Forum held every 2nd Tuesday of the month from 12-1PM in Building 500, 8th Floor, Bushnell Auditorium. This monthly meeting is open to all campus clinical research coordinators and Principle Investigators.

You must be a member to utilize ETCD resources, apply for funding opportunities, and attend events. To become a member, please visit our membership page. Membership is free.

An individual may take one or more of the these training courses as many times as they feel appropriate, in no particular order. Some training courses are available online.

VIEW THE REGULATORY CALENDAR

• Overview of Human Subjects Regulations --This 2 hour training will provide an introduction to human subjects research and the differences between Exempt, Expedited, and Full Board reviews and an introduction to human subject research involving vulnerable populations.
• Clinical Trial Design -- This is a 1-hour course that provides insight into how and why clinical trials are designed the way they are. Topics include defining the study population, common characteristics, key aims of phases, randomization, blinding, and outcomes analysis. This course is perfect for people who have worked in clinical trials and want to better understand the science behind the method and anyone who is considering designing a clinical trial.
• Colorado Multiple Institutional Review Board (COMIRB) Submission --In this 2 hour training participants will learn the step by step guide to filling out the COMIRB application and the attachments.
• Introduction to Clinical Trials and Good Clinical Practice --This is a short 2-hour course that provides the basic foundation for understanding clinical trials research. Topics include the drug development process, the device development process, regulations and guidelines, and the organizations and personnel involved in clinical trials. This course is perfect for people who are interested in working in clinical trials, new to clinical trials or people who have worked in clinical trials but have not had formal training.
• IRB Responsibilities After Approval --This 2 hour training will review the reporting responsibilities of the PI once the study has been initially approved by COMIRB. It will include how to submit unanticipated problems, amendments and continuing review requirements.
• Budgeting for Clinical Trials--This online training will go over steps on creating the budget template, thinking through what needs to be included, and how to check for overlooked items.
• Writing Informed Consents --This training will go over considerations and regulations for the entire consent process. Participants will also learn how to write consents at reading levels below 8th grade and how to check for missing pieces.
• Informed Consent Process -- This course will take the student through the detailed, step by step process of obtaining patient/subject informed consent. This includes a discussion of the elements of informed consent, documenting the informed consent process and ensuring an informed consent process has taken place.
• Clinical Trial Conduct and Practicum -- This is a 2.5-hour course that provides an opportunity to gain and immediately apply knowledge regarding clinical trial research with hands-on exercises. Skills gained will include pre-study activities including how to get chosen as a clinical trial site, completion of a 1572; mid-study activities including referencing a protocol, conducting the informed consent process, source doc to CRF completion, and assessing adverse events/serious adverse events; and finally close-out activities. This course is perfect for people who are working in clinical trials and want a hands-on experience to develop or enhance their skill set.
• Recruitment for Clinical Trials-- This 2 hour training will go over the steps involved in recruitment, national studies that have had a high take-up and retention rate, and the regulations surrounding recruitment. Also included will be a section on recruiting protected and special populations. Instructor: Yvonne Kellar-Guenther
• Introduction to Responsible Conduct of Research -- This course provides the student with a practical overview of the rules, regulations, and professional practices that define responsible conduct of research.

For questions, please contact:

Clinical Research Support Center
303.724.1111