The Essentials of Clinical Trials for Beginners
This 16-week online self-paced course will chart a roadmap for those who are keen to gain foundational knowledge on clinical trials. The course covers all the basic knowledge required of a clinical research coordinator to conduct a trial at site. You can access this course anytime, anywhere within 16 weeks at your own pace.
The registration page can be accessed at https://for.sg/tms8p2.
Topics covered in the programme:
|
Topic |
Singapore version (Covers local requirements of running clinical trials in Singapore) |
Overseas version (Covers generic requirements of running clinical trials based on Good Clinical Practice) |
|
Introduction to Clinical Research |
✓ |
✓ |
|
Research Team |
✓ |
✓ |
|
Protocol Feasibility |
✓ |
✓ |
|
Clinical Trial Agreement |
✓ |
|
|
Developing the Study Budget |
✓ |
|
|
Elements of Clinical Trial Protocol |
✓ |
✓ |
|
Ethics Board & Submission to Singapore IRBs |
✓ |
|
|
Study Start-up Activities |
✓ |
✓ |
|
Informed Consent |
✓ |
✓ |
|
Subject Screening and Recruitment |
✓ |
✓ |
|
Amendment, Continuing review and other Reporting to IRB (Protocol deviation and non-compliance, CAPA) |
✓ |
|
|
Protocol deviation and non-compliance, CAPA |
✓ |
|
|
Safety reporting to Singapore IRBs |
✓ |
|
|
Managing Adverse Events |
|
✓ |
|
Source Documentation |
✓ |
✓ |
|
Study Follow-up and Discontinuation |
✓ |
✓ |
|
Essential Documents |
✓ |
✓ |
|
Clinical Data Management & CRF Queries |
✓ |
✓ |
|
Randomisation and Unblinding |
✓ |
✓ |
|
Investigational Product Management |
✓ |
✓ |
|
Investigator Meeting and Site Initiation Visit |
✓ |
✓ |
|
Monitoring Visit Preparation |
✓ |
✓ |
|
Site Closure Activities |
✓ |
✓ |
|
Medical modules |
✓ |
|
|
Research Misconduct and Fraud |
✓ |
✓ |
|
Pre and post programme assessment |
✓ |
✓ |
Please contact us at scriacademy@scri.cris.sg for bulk registrations.