What is the Clinical Research Foundations Program?

Clinical Research Foundations is the initial level of the Clinical Research Accelerator Training Program, designed for all incoming researchers to quickly learn the fundamentals for conducting clinical research at UT Southwestern. Clinical Research Foundations introduces new and/or newly hired clinical researchers to the concepts and skills necessary to be successful in their role.

The Foundations level of the Clinical Research Accelerator Training Program is geared toward Clinical Research Managers, Clinical Research Coordinators (CRCs), Clinical Research Assistants (CRAs) and Research Nurses. However, all managers can assign this curriculum as needed to other applicable individuals that may benefit from this training. Moreover, individual departments can additionally assign their own supplemental and department-specific training to teams at their discretion. More information on the Clinical Research Foundations Curriculum components is outlined below. 

What is included in the Clinical Research Foundations Curriculum?

The Clinical Research Foundations Curriculum is based on core competencies created by The Joint Task Force for Clinical Trial Competency (JTF), an international team of investigators, educators, and clinical research professionals. UT Southwestern has adopted this framework and modified it for our training program to provide education on conducting safe, ethical, and high-quality clinical research. The curriculum consists of two discrete but complimentary programs:

• Clinical Research Foundations Training - an online, self-paced course completed through the CITI training platform. This course is either assigned as a mandatory requirement by the OCR or individuals can opt to enroll for their own personal enrichment.
• Clinical Research Foundations Mentoring - an interactive mentoring program pairing new researchers with an experienced clinical research professional. Individuals will be assigned to this program by the OCR and invites will be sent via email.

Completion of Clinical Research Foundations is mandatory for individuals who are new to research at UT Southwestern. Upon completion of both programs, researchers will receive a certificate of completion from the Office of Clinical Research. If you have any questions about this, please OCR@utsouthwestern.edu us.

Clinical Research Foundations Training

The UT Southwestern Clinical Research Foundations Training is an online, self-paced course available through the CITI learning portal which provides comprehensive education and ensures research personnel have a consistent foundational understanding of the requirements to successfully deliver clinical research. The course consists of the three below components: 

For further information, please visit the Clinical Research Foundations Training Page.

Clinical Research Foundations Mentoring

The Clinical Research Foundations Mentoring Program is one of the core structures that supports the Clinical Research Training Program. The purpose of this mentoring program is to facilitate the overall development of new clinical researchers by providing a resource and networking environment that will promote the concepts and skills necessary for new clinical research mentees to quickly onboard to their new role. At UTSW, we have designed a Clinical Research Foundations Mentoring program pairing an experienced clinical researcher (the mentor) with a new member of the clinical research team (mentee). Within this dyad, the mentor advises and guides the mentee through a carefully designed and structured program that introduces critical aspects of clinical research management via interactive activities, role play, review of real-world materials and systems, and mentor-mentee discussions.

Participants in the foundations level of the mentoring program will cover the following subjects:

Both mentor and mentee participants in this program will attend a brief orientation with the Program Facilitator to understand the structure of the program, review the documentation and resources available to all participants, as well as receive significant information on program requirements, such as the SMART goal.

For further information, please visit the Clinical Research Foundations Mentoring Page.

Clinical Research Handbook

In addition to the above modules, all staff have access to a handbook, “Clinical Research Handbook: A Guide to Conducting Clinical Research at UT Southwestern Medical Center and Affiliates,” which is intended to accompany and complement the above recordings and to serve as an additional resource with searchable features and active links throughout. Access a PDF of the handbook here.

Who is required to take the Clinical Research Foundations Program?

Researchers who are new to research at UT Southwestern and hired into the below job titles will be required to take Clinical Research Foundations training and mentoring as part of their onboarding process.

The online, self-paced training should be completed within 30 days of receipt of your onboarding email from the Office of Clinical Research.

The Clinical Research Foundations Mentoring Program is designed to be completed over several months, and does not need to be completed within the 30 day window.

Although this training is required for new research hires, all staff are welcome to access and view the materials to reinforce their own learning and understanding. To access the contents of this training as an existing staff member, please review the information below. Additionally, departments canassign this training to staff members as needed.

How can I access the Clinical Research Foundations Training?

If you are required to complete the full Clinical Research Foundations Training curriculum:

The Clinical Research Foundations Training is hosted within the CITI training platform. In order to access the course, login to your CITI account and answer "yes" to Question 4 “Will you be performing any research-related duties as part of your job (e.g., Clinical Research Assistant, Clinical Research Coordinator, etc.)?”. By selecting this question in CITI you will automatically populate your account with the required training.

For further details on accessing the training - please refer to the Clinical Research Foundations CITI Tip Sheet.

If you are not required to complete the full Clinical Research Foundations Training curriculum and wish to view any of videos on an ad-hoc basis, please follow the below links to review the resources:

Scientific Principles of Clinical Research

This is a video series presented by Professor Heidi Jacobe, MD, Associate Dean of Clinical Research Development and Professor in Dermatology. In this presentation, Dr. Jacobe covers the principles, key concepts, and methodology behind clinical research design.

Introduction to Clinical Research at UT Southwestern Medical Center and Affiliates

This video series includes introductions by the UT Southwestern Institutional Official for Clinical Research, Dr. Eric Peterson, the Associate Dean for Translational Science and Education, Dr. Robert Toto, followed by over 30 individual departments spanning all the major areas of clinical research. Each department presents a brief overview of how they support clinical research operations at UTSW.

How can I access the Clinical Research Foundations Mentoring?

For Mentees:

If you are an incoming researcher at UT Southwestern, and hired with one of the above listed job titles, you will be required to complete the Clinical Research Foundations Mentoring Program as part of your onboarding training. New clinical researchers will be contacted by OCR@utsouthwestern.edu to fill out a REDCap survey to gather basic data, including current study workloads and needs. The Program Facilitators will review each mentee’s needs and do their best to match them with qualified mentors based on similar work environments (e.g., study phase, observational or interventional design, etc.) as well as additional needs (e.g., exposure to laboratory skills, contracts, etc.). For further information, please visit the Clinical Research Foundations Mentoring Page.

For Mentors:

Thank you for your interest in joining our program! The OCR is looking for experienced coordinators and/or clinical researchers with at least 3 years combined working experience in research, preferably with exposure to a variety of types of research. Please contact the OCR by OCR@utsouthwestern.edu if you would like to learn more about becoming a mentor in this program.

Helpful Resources

• Clinical Research Foundations Training Curriculum - This document explains all the components in the Clinical Research Foundations Training Program with brief descriptions for each segment.
• Information Sheet: Clinical Research Foundations Mentoring Program This document explains all the components in the Clinical Research Foundations Mentoring Program with brief descriptions for each segment.
• Clinical Research Handbook - This handbook is intended to accompany and complement the Clinical Research Foundations Curriculum and to serve as an additional resource.
• Clinical Research Foundations CITI Tip Sheet - This document gives tips on registering to CITI and completing the Clinical Research Foundations Training course.
• Clinical Research Professional Competencies - The Joint Task Force for Clinical Trial Competency created a core competency framework for clinical research professionals. This serves as a basis for clinical research training at UT Southwestern Medical Center.
• Clinical Research Onboarding Checklist - This checklist helps support new clinical research personnel with onboarding training required by UT Southwestern, which extends beyond the Clinical Research Foundations curriculum.
• Clinical Research Foundations Training SOP - This SOP outlines the Clinical Research Foundations Training Program policies and procedures. 
• FAQs – For any questions, go visit our FAQ page. If you still need help, OCR@utsouthwestern.edu!

This program was created with support from the Human Research Protections Program (HRPP), Office of Clinical Research (OCR), and the Clinical and Translational Science Award (CTSA) Program.

This content was last updated on 18th April, 2024. For any questions, OCR@utsouthwestern.edu.