Introduction

Approximate Time: 1 hour

Course Description: This free course is designed for GCRC Investigators and their Team to assist with meeting the responsibility of providing an individualized plan to meet the new federal mandates and enhance research subject safety by clearly defining safety related issues.
The participant will register and begin the course with introductory material followed by an audio presentation synchronized to slides. Reference material as well as linkages to relevant web-sites on the internet will also provide supplemental resources for further study.
After taking the course, participants will respond to self-study questions and provide feedback about the course materials. Upon completion, participants will receive a certificate to document their participation.

Objectives:
Upon completion of this course, the researcher will be able to:

1. Describe the rationale of a data and safety monitoring plan, including issues related to monitoring the environment, protecting the data, and documentation/reporting of adverse events
2. Develop a data and safety monitoring plan, according to current federal guidelines.
   

Faculty: This course is presented by Michele A . Carter, Ph.D. who is a Member of the Institute for the Medical Humanities, Associate Professor in Preventive Medicine and Community Health and Research Subject Advocate at the General Clinical Research Center at the University of Texas Medical Branch in Galveston, Texas.

Development Team: The Clinical Research Education Office and General Clinical Research Cener would like to express gratitude to the development team, without whom this project could not have been completed. Many thanks to Mary Donna Piazza (Academic Technology Center), Anthony Hernandez (Academic Technology Center), Nick Marr (Academic Technology Center) and Marie Carr (Clinical Research Education Office).

Instructions:

1. Review the course learning objectives and determine if these match your individual learning needs.
2. Participants should confirm computer system requirements, with the link below. Our audio is designed with streaming media and a link to the free download of Real Player is available from the computer system requirements link on this page.
3. Participants will register using their UTMB user ID and password.
4. Select the course button and view the presentation. This course takes approximately one hour to complete. This course is also designed to include the possibility to pause or return later for completion.
5. Complete the "Check Your Knowledge" questions and course feedback. All information is required before the attendance certificate can be processed.
6. Participants will receive immediate feedback on "Check Your Knowledge" question responses. If necessary, review responses.
7. Upon successful completion of the course, a certificate of completion will be sent through campus mail for the participant's records.

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