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?
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
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
