DESCRIPTION
This course provides basic understanding of Good Clinical Practices (GCPs). This program provides an overview of the purpose, history, regulations, clinical development, roles and responsibilities.
LEARNING OBJECTIVES
Upon completion, participants will understand:
- The purpose of Good Clinical Practices
- The history and development of Good Clinical Practices
- The importance of informed consent to the clinical research process
- How GCPs affect different clinical development activities
- The interplay between FDA regulations and the International Conference on Harmonization (ICH) GCP guideline
- The roles and responsibilities of sponsors, investigators, IRBs/IECs, and IDMCs
KEY TOPICS
- The Development of GCPs
- GCPs in the Real World
- GCP Roles and Responsibilities
TARGET AUDIENCE
This online course is designed for new personnel in Regulatory Affairs, Compliance, Clinical Operations, Quality Assurance (QA), and personnel in other related departments.
Cost: Member $200; Non-Member $275
Type: Web-based Class
RAC Points: Participants receive 3 RAC points.
Frequently Asked Questions
What is the time period of the course and when is the end date?
You will have 60 days to complete the course from the time of your purchase. The end date is calculated from your purchase date. You can complete the course work at any time, day or night, that fits into your schedule. There is no pre-assigned time that you need to be online. It is a completely self-paced online course.
How many hours will it take to take the course?
It will take approximately 2-3 hours online to complete the course. This includes time for the final exam.
Is there any home work?
No, all the information you need to complete the course is included in the online course materials.
Is there any special computer requirements for access or software that must be downloaded?
RAPS Online University works best with an up-to-date version of Internet Explorer or Firefox. A current version of Flash is a common plug-in used in our courses. For your convenience, the URL to download this plug-in can be found at www.macromedia.com.
Is the purchase of any additional text required?
No, all the information needed to complete the course is included in the online course. However, RAPS does offer books on GLPs that you may find of interest as supplemental reading to the course, but they are not required texts and you may complete the course without them.