The Essentials of Clinical Trials for Beginners
Course Description
The Essentials of Clinical Trials for Beginners online course will provide a concise introduction to coordinating a clinical trial; from drug development to ethics, subject recruitment and monitoring. It covers the basic theoretical aspects of the major clinical trial activities, while the in-depth theoretical and application will be covered in the Clinical Research Coordinator Level 1 Programme. All participants of the Clinical Research Coordinator Level 1 Programme have to complete The Essentials of Clinical Trials for Beginners online course prior to attending the classroom training. Completion of the online course does not entitle for module exemption to Clinical Research Coordinator Level 1 Programme.
Click here for more information on the Clinical Research Coordinator Level 1 Programme.
Topic 1: Introduction to Clinical Trial
What you will learn:
1. Understand the drug development process.
2. Identify the different phases in clinical trial.
3. Comprehend the establishment of Good Clinical Practice.
4. Understand the clinical trial governance framework in Singapore.
Duration: 16min 15sec | Documents: Click here to download the handout
Topic 2: Research Team
What you will learn:
1. Distinguish the roles and responsibilities of the Principal Investigator (PI) and other study team members.
2. Describe the good practice for documenting the delegation of study responsibilities and training received by the study team members to perform the trial-related procedures.
3. Discuss the activities involved when there is a change or addition of PI and study team members.
4. Understand the importance of communication within the study team members for successful implementation of trial.
Duration: 27min 09sec | Documents: Click here to download the handout
Topic 3: Elements of Clinical Trial Protocol
What you will learn:
1. Describe what is a research protocol.
2. Discuss the key elements of a research protocol.
3. Explain the different types of trial designs, such as double-blinded, single-blinded and open-label trials.
Duration: 26min 03sec | Documents: Click here to download the handout
Topic 4: Site Start-up Activities
What you will learn:
1. Define study start-up activity.
2. Explain the importance of having efficient clinical trial start-up activities.
3. Discuss the activities involved during the clinical trial start-up phase, such as mapping the processes, clinical trial agreement, budget, and logistic preparation.
Duration: 28min 11sec | Documents: Click here to download the handout
Topic 5: Ethics Submission
What you will learn:
1. Describe what is an Institutional Review Board (IRB).
2. Discuss the types of IRB review – exempted, expedited and full board review.
3. Explain the different types of IRB application review outcome.
Duration: 27min 31sec | Documents: Click here to download the handout
Topic 6: Subject Recruitment and Screening
What you will learn:
1. Describe the different types of recruitment strategies.
2. Identify the differences between pre-screening and screening.
3. Discuss the activities involved during pre-screening and screening.
Duration: 11min 58sec | Documents: Click here to download the handout
Topic 7: Study Follow-Up and Discontinuation
What you will learn:
1. Learn how to schedule and track study visit.
2. Understand how abnormal finding in clinical trial are handled.
3. Describe the importance of trial subject retention and compliance.
4. Describe the principles for trial subject compensation.
Duration: 16min 16sec | Documents: Click here to download the handout
Topic 8: Safety Reporting to IRB
What you will learn:
1. Define adverse event, serious adverse event, adverse drug reaction and Suspected Unexpected Serious Adverse Reaction (SUSAR).
2. Describe the IRB safety reporting process for adverse event and serious adverse event.
Duration: 18min 33sec | Documents: Click here to download the handout
Topic 9: Monitoring Visit Preparation
What you will learn:
1. Explain the purpose of site monitoring visit.
2. Describe the types of activities involved during a site monitoring visit.
3. Discuss how to prepare for a site monitoring visit.
Duration: 13min 44sec | Documents: Click here to download the handout