Clinical Trial Domain Overview


Description

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. SASĀ® 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 SASĀ® 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

Topics Covered:
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

Content
  • Introduction to Clinical Trials
  • Overview of New Drug Development Part 1
  • Overview of New Drug Development Part 2
  • Overview of New Drug Development Part 3
  • Introduction to Clinical Research
  • Clinical Trial Phases Part 1
  • Clinical Trial Phases Part 2
  • Clinical Trial Phases Part 3
  • Clinical Trial Designs Part 1
  • Clinical Trial Designs Part 2
  • Clinical Trial Designs Part 3
  • Clinical Trial Protocol
  • Regulatory Guidelines
  • GCP & Schedule Y Part 1
  • GCP & Schedule Y Part 2
  • 21CFR Part11 Part 1
  • 21CFR Part11 Part 2
  • Regulations and Ethics Part 1
  • Regulations and Ethics Part 2
  • Regulations and Ethics Part 3
  • Clinical Trial Documents
  • Informed Consent Process Part 1
  • Informed Consent Process Part 2
  • Essential Documents Part 1
  • Essential Documents Part 2
  • Work-flow of Clinical Trial Study
  • Study Conduct Part 1
  • Study Conduct Part 2
  • Assessment
  • Course Evaluation
Completion rules
  • All units must be completed
  • Leads to a certification with a duration: Forever