Objectives
Brought to you in partnership by SingHealth Investigational Medicine Unit and SingHealth Academy, this 1.5-day course equips participants with knowledge on good clinical practices in Singapore.
Healthcare professionals involved in the designing, conducting, documenting and reporting of clinical trials will gain insights into the importance and guidelines of good clinical practices.
Programme Outline
Day 1
•Introduction to Drug Development Process
•Research Ethics Framework
•SingHealth CIRB - Essential Notes for the PI
•Regulatory Requirements for Clinical Trials and Clinical Research Materials
•GCP Inspection
•Informed Consent
•What PIs should know about Investigator Site File
•What PIs should know about managing Investigational Products
•Clinical Trial Safety
•Responsibilities of Sponsor
Day 2
•Overview of Legal Framework for Clinical Trials and CTA
•Overview of Clinical Trial Insurance
•Quality Assurance in the World of Clinical Trial
•Fraud and Misconduct
Note: It is compulsory to participate in the quiz at the end of day 2 to receive the certificate of attendance.
*Programme may be subjected to change