The Essentials of Clinical Trials for Investigators
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:
|
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 |
✓ |
✓ |
|
Site Closure Activities |
✓ |
✓ |
|
Research Misconduct and Fraud |
✓ |
✓ |
|
Pre and post programme assessment |
✓ |
✓ |
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.