CT: Good Clinical Practices
FPM-40204
Topics include the definition and identification of good clinical practices (GCPs); how GCPs affect the conduct of clinical trials; regulating agencies and applicable regulations from the Code of Federal Regulations and ICH guidelines; state regulations; obligations of investigators, sponsors, monitors, and IRBs; compliance and accountability during clinical trials; protocol violations and deviations; consequence of falsification of data and/or patient records; and the blacklist. Device regulations also covered.
Course Information
Course sessions
Section ID:
Class type:
This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
Textbooks:
The Fundamentals of clinical Research: A Universal Guide for Implementing Good Clinical Practice 1st
by Dubinsky, P. Michael & Henry, Karen A
ISBN / ASIN: 9781118949597
You may purchase textbooks via the UC San Diego Bookstore.
Policies:
Note:
Schedule:
Instructor:
Suzan Olson, PhD, MHS, RN
Formative/Summative Usability/Human Factors Testing in Medical Device and Combination Products
Suzan Olson works with manufacturers to plan and execute human factors evaluations and clinical trials covering pediatrics and adults of combinations products and medical devices. She earned a doctorate in psychology and a master's in health administration from Wichita State University as well as a bachelor's in health administration from Ottowa University. She is also a registered nurse.
Section ID:
Class type:
This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
Textbooks:
The Fundamentals of clinical Research: A Universal Guide for Implementing Good Clinical Practice 1st
by Dubinsky, P. Michael & Henry, Karen A
ISBN / ASIN: 9781118949597
You may purchase textbooks via the UC San Diego Bookstore.
Policies:
Note:
Schedule:
Instructor:
Suzan Olson, PhD, MHS, RN
Formative/Summative Usability/Human Factors Testing in Medical Device and Combination Products
Suzan Olson works with manufacturers to plan and execute human factors evaluations and clinical trials covering pediatrics and adults of combinations products and medical devices. She earned a doctorate in psychology and a master's in health administration from Wichita State University as well as a bachelor's in health administration from Ottowa University. She is also a registered nurse.
