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 52sec | 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 01sec | 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

Training Disclaimer:
This training and training materials are for educational and informational purposes only. This training material should be read in conjunction with the applicable latest research policy and regulations from the learner’s research organization and/or institution, Singapore Regulatory Authority, and Ministry of Health. Kindly note that all information and opinions presented in this training and training materials were written to the best knowledge available at the time of writing.

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