OVERVIEW

AHRO Masterclass in Fundamental of Clinical Trials is organized by AHRO Center for Academic Research, AHRO University.

Description:
This introductory course is designed for professionals around the world who want to build their knowledge on designing and conducting randomised clinical trials. The course will not consider non-randomised trials or other observational studies. The main focus will be on large multi-centre clinical trials involving both drugs and interventional trials.

Course Outcome:
After the course, participants should be able to:

Describe various type of data and how they are used
Describe confidence interval and p-values
Describe how to identify information to perform basic sample size calculation
Describe and interpret simple analysis
Define correlation and simpler linear regression
Understand the value and opportunities of data
Describe randomisation, blocking and power calculations
Develop the knowledge of reporting and interpretation of randomized clinical trial

Course Modules:

Principle of clinical trials
Introduction of observational studies
Randomisation
Blinding and Placebos
Monitoring trial results
Reporting trial results
Subgroup analysis
Multiple outcomes, treatments
Alternative designs
Protocol Reviews, Implementation, and Monitoring
Introduction to Informed Consent
Introduction to Good Clinical Practice

Teaching: The course will be taught through series of online tutorials, online formative exercises, series of pod-casts and discussion forums. It is compulsory that student take part in 90% of online tutorials. Self-directed learning is an essential component of this training. Electronic learning resources will be made available via our VLE.

Learning breakdown: Our online courses combine several elements to create a balanced blend of learning. Learners will be able to learn at their own pace during the week by viewing content, engaged in discussions, and completing assignments. It is expected that on the average, 8 to 10 hours per week is required for a course.

Assessment: Assessment for this course is based on summative assessment which counts to the module mark. Each summative assessment for a module will be made of a 1000 word essays, scientific article of high standard, 15 minutes presentations, and 3000 worded final assignment.

Duration: 12 weeks

Commitment: 8-10 hours per week

Note:
The time limit of 90 days starts from the course registration.