Clinical Research Foundations Training
Clinical Research Foundations Courses:
The UT Southwestern Clinical Research Foundations Training Program, the training component of the Foundations Training Curriculum, is designed to provide a comprehensive overview of foundational research knowledge and ensures that research personnel have a consistent and standardized foundational understanding of the requirements to successfully deliver clinical research.
If you are required to take the Clinical Research Foundations Training course as part of your onboarding, please make sure that you access this course through the CITI website. For instructions on how to enroll for this course, please review the Clinical Research Foundations CITI Tip Sheet.
If you have any questions about whether you are required to complete the Clinical Resarch Foundations CITI training, please refer to our Frequently Asked Questions (FAQs) page or OCR@utsouthwestern.edu.
Scientific Principles of Clinical Research
Presenter: Dr. Heidi Jacobe
Scientific Principles of Clinical Research
Brief Course Outline: 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.
Course Components:
- Unit 1: Principles in Research - | Slides |
- Unit 2: Key Concepts of Clinical Research - | Slides |
- Unit 3: Methods of Research (Part 1) - | Slides |
- Unit 4: Methods of Research (Part 2) - | Slides |
Introduction to Clinical Research at UT Southwestern Medical Center and Affiliates
Presenters: Various
Leadership Welcome and Major Departments
Brief Course Outline: 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.
View the Leadership Welcome and Major Departments video series
Leadership Welcome
- Eric Peterson, M.D., MPH, Vice Provost and Senior Associate Dean of Clinical Research, Institutional Official for Clinical Research - | Chapter 1 |
- Robert D. Toto, M.D., Associate Dean, Translational Science and Education, Clinical and Translational Science Award (CTSA) Program - | Chapter 2 |
Major Departments
- Structure of Clinical Research - | Chapter 3 | Slides |
- Office of Clinical Research (OCR) - | Chapter 4 | Slides |
- Human Research Protection Program (HRPP) - | Chapter 5 | Slides |
- Sponsored Programs Administration (SPA) - | Chapter 6 | Slides |
- Research Support & Regulatory Management (RSRM) - | Chapter 7 | | Slides |
Research Committees
Brief Course Outline: This video series includes information from all major research committees at UT Southwestern Medical Center including details about which studies they review and contacts for support and queries.
View the Research Committees video series
- Research Committees - | Chapter 1 |
- Institutional Review Board (IRB) - | Chapter 2 | Slides |
- Conflict of Interest (COI) & Commitment (COC) - | Chapter 3 | Slides |
- Institutional Conflict of Interest (ICOI) - | Chapter 4 | Slides |
- Stem Cell Research Oversight (SCRO) Committee - | Chapter 5 | Slides |
- Simmons Comprehensive Cancer Center: Protocol Review and Monitoring System (PRMS) - | Chapter 6 | Slides |
- Subcommittee for Human Use Radiation (SHUR) - | Chapter 7 | Slides |
- Radioactive Drug Research Committee (RDRC) - | Chapter 8 | Slides |
- Institutional Biosafety Committee (IBC) - | Chapter 9 | Slides |
- Campus Laser Safety Committee - | Chapter 10A | Slides |
- Information Systems Acquisition Committee (ISAC) - | Chapter 10B | | Slides |
Other Approvals and Resource Offices
Brief course Outline: This video series includes information from other offices involved in the research approval process including those that provide resources and support for teams in research development and implementation.
View the Other Approvals and Resource Offices video series
- Other Approvals and Resource Offices - | Chapter 1 |
- Clinical Trial Finance Team - | Chapter 2 | Slides |
- Clinical Research Services - | Chapter 3 | Slides |
- Grants - | Chapter 4 | Slides |
- Research Staff Credentialing - | Chapter 5 | Slides |
- Office for Technology Development (OTD) - | Chapter 6 | Slides |
- Medical Education - | Chapter 7A | Slides |
- Communications, Marketing, & Public Affairs (CMPA) - | Chapter 7B | | Slides |
- Export Control (EC) and International Collaborations - | Chapter 8 | | Slides |
- Advanced Imaging Research Center (AIRC) - | Chapter 9 | Slides |
Performance Site Approvals
Brief Course Outline: This video series includes information on the performance site approval process and the different performance sites affiliated with UT Southwestern Medical Center.
View the Performance Site Approvals video series
- Performance Site Approvals: Specific Requirements - | Chapter 1 |
- UT Southwestern: Office of Clinical Trial Management (OCTM) - | Chapter 2 | Slides |
- Children’s Health - | Chapter 3 | Slides |
- Parkland Health - | Chapter 4 | Slides |
- Scottish Rite for Children - | Chapter 5 | Slides |
- Texas Health Resources - | Chapter 6 | Slides |
Resources
Brief Course Outline: This video series includes information on the different resources available to support research at UT Southwestern Medical Center.
View the Clinical Research Resources video series
Technology - | Chapter 1 | Slides |
- eIRB
- REDCap
- EPIC
- VELOS
- eFlorence
Support
- Quality Assurance and Monitoring (QAM) - | Chapter 2 | Slides |
- Regulatory Support Office (RSO) - | Chapter 3 | Slides |
- Aston Clinical Research Unit (CRU) - | Chapter 4 | Slides |
- Research Participant Recruitment Team - | Chapter 5 | Slides |
- Office of Community Health & Research Engagement (OCHRE) - | Chapter 6 | Slides |
- Biostatistics, Epidemiology & Research Design (BERD) - | Chapter 7 | | Slides |
- Research Design Studio - | Chapter 8 | Slides |
- Clinical Laboratory Services Research (CLSR) - | Chapter 9 | Slides |
- Investigational Drug Services (IDS) - | Chapter 10 | Slides |
Governance - | Chapter 11 |
- Responsible Conduct of Research - | Chapter 12 | Slides |
- Research Compliance Program - | Chapter 13 | Slides |
- The HIPAA Privacy Office
- Information Security
- Legal Counsel
- The Biorepository Oversight Committee
- UT Southwestern Medical Center Policies
Closing Remarks - | Chapter 14 |
Required CITI Clinical Research Modules
There are 16 individual CITI modules, tailored to cover competencies required as part of the Clinical Research Foundations Training curriculum on the CITI website. Each module contains detailed content, images, supplemental materials (such as case studies), and a quiz. These modules rovide clinical research professionals with basic and thorough training tailored to the researcher’s critical role in the conduct of clinical trials.
To access the Clinical Research Foundations Course, please make sure that you access this course through the CITI website. For instructions on how to enroll for this course, please review the Clinical Research Foundations CITI Tip Sheet.
Clinical Research Handbook
To accompany the Clinical Research Accelerator Training Program curriculum, the Office of Clinical Research has developed a comprehensive Clinical Research Handbook with further information about all above departments and resources, in addition to other helpful material about UT Southwestern policies and processes. The handbook can be found here.
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.
- 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 course.
- 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, please refer to the FAQs page, or OCR@utsouthwestern.edu.