The Essentials of Clinical Trials for Investigators

29 JAN 2024

This is a 16-week online self-paced course that will equip a clinician investigator with the essential skills in navigating through the clinical trial activities with confidence and ease.

The course covers the fundamental operational knowledge of conducting a clinical trial, which includes how to get ahead of administrative tasks with ease, understand the regulatory landscape and what it takes during screening and recruitment. With this knowledge, you can design and optimize the protocol to improve the trial design, management, and/or processes with the highest likelihood of success.

This course can be accessed anytime, anywhere at own pace.

Click here to register now!

Topics covered in the programme:

  • Introduction to Clinical Research

  • Protocol Feasibility

  • Developing the Study Budget

  • Ethics Board & Submission to Singapore IRBs

  • Participant Screening and Recruitment

  • Amendment, Continuing review and other Reporting to IRB

  • Source Record

  • Study Follow-up and Discontinuation

  • Investigational Product Management

  • Site Closure Activities

  • Responsibilities of sponsor PI in multicenter IIT

  • Safety Monitoring

  • Quality Management System

  • Pre and post programme assessment

  • Research Team

  • Clinical Trial Agreement

  • Elements of Clinical Trial Protocol

  • Site Start-up Activities

  • Informed Consent

  • Clinical Data Management & CRF Queries

  • Essential Records

  • Safety reporting to Singapore IRBs

  • Randomisation and Unblinding

  • Research Misconduct and Fraud

  • Protocol Review

  • Study closure for multicenter IITs

  • Site Feasibility for multicenter IITs

If you are interested for bulk subscription for your colleagues and friends, please write in to us at scriacademy@scri.cris.sg to find out more.