Course Title: Clinical Trial Design and Management

Part A: Course Overview

Course Title: Clinical Trial Design and Management

Credit Points: 12.00


Course Code




Learning Mode

Teaching Period(s)


Bundoora Campus


160H Medical Sciences


Sem 1 2006,
Sem 1 2007,
Sem 1 2008,
Sem 1 2009,
Sem 1 2010,
Sem 1 2011,
Sem 1 2012,
Sem 1 2013,
Sem 1 2014,
Sem 1 2015


Bundoora Campus


173H School of Health and Biomed


Sem 1 2017,
Sem 1 2018

Course Coordinator: Dr Paul Bertrand

Course Coordinator Phone: +61 3 9925 7898

Course Coordinator Email:

Course Coordinator Location: 201.02.041

Course Coordinator Availability: By appointment only

Pre-requisite Courses and Assumed Knowledge and Capabilities

Required prior study (Pre-requisites)



Course Description

The course provides an overview of the drug development process in human volunteers and patients, that follows pre-clinical safety and toxicity studies in animals. The emphasis is on clinical trial design and management, including clinical epidemiology.

Objectives/Learning Outcomes/Capability Development

This course contributes to the following program level outcomes for BP311 Bachelor of Pharmaceutical Sciences:

  • Critically analyse and solve scientific problems (PLO 2)
  • Communication and teamwork (PLO 3)
  • Investigation and analysis (PLO 4)
  • Accountability for your own learning and professional conduct (PLO5)


On completion of this course you should be able to:

  1. demonstrate an understanding of clinical trials, including the four (4) different phases of clinical trials, standard operating procedures, regulatory approval and ethics committee review;
  2. conduct a clinical trial, including study protocol, study design, investigator and subject selection, monitoring of the study, and analysing the study data;
  3. apply biostatistics in the analysis of clinical data;
  4. measure drug effects in humans applying principles of pharmaco-epidemiology

Overview of Learning Activities

This course is designed to assist in the preparation of graduates for employment as responsible workers in the pharmaceutical industry or related government areas, or to pursue postgraduate clinical research in pharmacology or toxicology. External experts from industry will participate in the presentation of the course material to ensure that the course remains relevant to the workplace, thus enhancing the employability of graduates.

Each week, you will undertake the equivalent of two hours of lecture, one hour of tutorial, and one hour of workshop.

In addition, you can expect to spend a minimum of six hours per week in independent study.

Overview of Learning Resources

Learning resources used in this course include textbooks, lecture notes (PowerPoint presentations), Echo360 recordings or short videos of lecture presentations and tutorial classes. The Canvas course site in myRMIT provides opportunities for students to access much of this material and use asynchronous discussions as an additional mode of learning. You will also be expected to download peer-reviewed articles and references from the internet.

Further resources can be found at:

Overview of Assessment

Formal assessments may be conducted in the form of a written mid-semester test and a written final examination held during the formal examination period. The written assessments may assess the students’ understanding of the material presented, as well as the application of that knowledge to clinical trials management in the pharmaceutical industry.

There may be a major written assignment and assessment through participation in workshops and tutorials. Tutorials and workshops held throughout the semester are designed to stimulate problem-solving skills and critical thinking, and to develop knowledge and practical experience in clinical study design and analysis.

Note that:

This course has no hurdle requirements.

Formative Assessment Tasks:  Review quizzes online

Weighting 0%

Note: these assessment tasks enable formative assessment of your knowledge in order to provide you with helpful feedback to support your improvement for subsequent tests and exams. It carries no marks and is not a hurdle requirement.

This assessment task supports CLOs 1 and 4

Assessment Task 1:  Tutorial activities

Weighting 10%

This assessment task supports CLOs 1, 2, 3 & 4

Assessment Task 2: Formal assessment - mid-session test

Weighting 15%

This assessment task supports CLO 1, 3 & 4

Assessment Task 3: Formal assessment - final examination

Weighting 40%

This assessment task supports CLO 1, 3 & 4

Assessment Task 4: Clinical trial proposal (group and individual)

Weighting 15% 

This assessment supports CLO 2

Assessment Task 5: Clinical trial report (Individual)

Weighting 20% 

This assessment supports CLO 2, 3 & 4