This short course aims at providing an overview of the clinical trial domain.The course is designed and delivered by Dr Ravindra Ghooi (http://in.linkedin.com/pub/ravindra-ghooi/4/1a6/32b/en), a veteran in the subject with over 42 years of professional and teaching experience in Clinical Research and Pharmacology.
Who should Attend?
1. SAS® Programmers / Statisticians working in Clinical Domain
2. Candidates who have begun a career in Clinical Trial Data Analytics or Clinical Research
3. Candidates trained in SAS® and aspiring to enter the Clinical Trial Services Industry
4. Candidates who are required to learn about the Clinical Trial Domain as part of their profession or academic studies
1. Overview of New Drug Development
2. Introduction to Clinical Research
3. GCP and Schedule Y
4. 21 CFR Part 11
5. Regulations and Ethics
6. Informed Consent Process
7. Clinical Trial Phases
8. Clinical Trial Design
9. Clinical Trial Protocol
10. Study Conduct
11. Essential Documents
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