Clinical Research Education Course - Basic

This educational program is designed and conducted by experienced clinical trial research professionals. The program covers clinical trial management, from planning to trial close-out activities, and provides practical recommendations for increasing the efficiency of clinical trial conduct at investigative sites. This program combines didactic presentations and interactive group sessions. Specific topics include human subject protections, GCP principles, institutional compliance, informed consent process, study initiation, study conduct, FDA inspection, documentation, investigational devices and drugs, reporting requirements, and management systems.

Due to the COVID-19 pandemic, this year the CRC course will be completely online via WebEx. We discussed the online format with our research community and together we agreed that it would be best to break the program into smaller sessions over several weeks instead of our usual format of two full days. You are welcome to sign up for all the sessions or only the sessions that interest you most. This course is free to all UTHealth staff and staff from TMC Institutions. 

Audience: Research nurses, research coordinators and research assistants. 

REGISTRATION OPEN

Location: WebEx 

TENTATIVE AGENDA

Day 1 - Tuesday, September 8, 2020                        

10 am to 11 am: Introduction to Clinical trials

11 am to 12 pm: IRB review

Day 2 - Thursday, September 10, 2020                    

11 am to 12 pm: Contract negotiations

12 pm to 1 pm: Coverage Analysis and Budgeting

Day 3 - Tuesday, September 15, 2020                      

11 am to 12 pm: Regulatory Affairs - IND/IDE/ct.gov

12 pm to 1 pm: Study Documents

Day 4 - Thursday, September 17, 2020                    

11 am to 12 pm: Study Initiation

12 pm to 1 pm: Study Roles and Responsibilities

Day 5 - Tuesday, September 22, 2020                      

11 am to 12 pm: Informed Consent Process

12 pm to 1 pm: Informed Consent - Special Circumstances

Day 6 - Thursday, September 24, 2020                    

11 am to 12 pm: Recruiting Strategies

12 pm to 1 pm: Scheduling Study Visits and Subject Retention

Day 7 - Tuesday, September 29, 2020                      

11 am to 12 pm: Protocol Deviations and Adverse events

12 pm to 1 pm: Auditing and monitoring

Day 8 - Thursday, October 1, 2020                            

11 am to 12 pm:IDS and Study Drug Accountability

12 pm to 1 pm: Investigational Devices

Day 9 - Tuesday, October 6, 2020                             

11 am to 12 pm: MHH Review and Approval Process

12 pm to 1 pm: HH Review and Approval Process


Questions, comments and suggestions?

clinicaltrials@uth.tmc.edu

ADDITIONAL RESOURCES

CLINICAL RESEARCH UNITS (CRU) | BERD | REDCap
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS | ANIMAL RESEARCH | ENVIRONMENTAL HEALTH & SAFETY | CORE LABORATORIES | SPONSORED PROJECTS TECHNOLOGY MANAGEMENT
OFFICE OF RESEARCH 

Center for Clinical and Translational Sciences

Clinical Trials Resource Center (CTRC)
7000 Fannin Street, Suite 795

Houston, Texas 77030
phone 713-500-3622
fax 713-500-0334
clinicaltrials@uth.tmc.edu