Part A: Course Overview

Course Title: Clinical Trial Design and Management

Credit Points: 12.00

Terms

Course Code

Campus

Career

School

Learning Mode

Teaching Period(s)

ONPS2304

Bundoora Campus

Undergraduate

160H Medical Sciences

Face-to-Face

 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

ONPS2304

Bundoora Campus

Undergraduate

173H School of Health and Biomed

Face-to-Face

 Sem 1 2017,
Sem 1 2018,
Sem 1 2019,
Sem 1 2020,
Sem 1 2021,
Sem 1 2022,
Sem 1 2023,
Sem 1 2024,
Sem 1 2025

Course Coordinator: Dr Paul Bertrand

Course Coordinator Phone: +61 3 9925 7898

Course Coordinator Email: paul.bertrand@rmit.edu.au

Course Coordinator Location: 201.02.041

Course Coordinator Availability: By appointment only


Pre-requisite Courses and Assumed Knowledge and Capabilities

Required Prior Study

You should have satisfactorily completed following course/s before you commence this course.

Alternatively, you may be able to demonstrate the required skills and knowledge before you start this course.

Contact your course coordinator if you think you may be eligible for recognition of prior learning.


Course Description

The course provides an overview of the clinical research required to support the drug development process in human volunteers and patients. The emphasis is on the design of interventional clinical trials and their organisation and management. The role of biostatistics, epidemiological reasoning and observational trials, and examples of interventional trials will be used to highlight best practice. 


Objectives/Learning Outcomes/Capability Development

This course contributes to the following program level outcomes for BP311P23 Bachelor of Pharmaceutical Sciences:

PLO 1 Apply a breadth and depth of pharmaceutical science knowledge, concepts and evidence in various real world settings using a scientific approach.
PLO 2 Apply systematic thinking and a range of high-level analytical skills using a blend of digital and traditional tools and technologies to solve complex scientific and medical problems related to pharmaceutical science.
PLO 3 Demonstrate knowledge of the regulatory frameworks relevant to pharmaceutical sciences and exhibit safe and ethical conduct.
PLO 4 Communicate clearly and effectively with diverse audiences utilising contemporary and traditional formats on topics related to pharmaceutical science employing integrity, inclusivity, and culturally safe practices.

 


Upon successful completion of this course, you will be able to:  

1. Demonstrate an understanding of the four (4) phases of clinical trials and how each design contributes to determining the safety and effectiveness of treatments; 

2. Explain the processes involved in organising and managing a clinical trial including selection and recruitment of participants, measurements and outcomes, and the roles of the clinical operations team; 

3. Conduct and report on a clinical trial, including the protocol, design, selection, and data collection using a simulated clinical trial environment; 

4. Explain and apply biostatistics in the analysis of simulated clinical trial data; 

5. Demonstrate responsibility and accountability for own learning and professional practice as part of a team. 


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.

You are encouraged to be proactive and self-directed in your learning, asking questions of your lecturer and/or peers and seeking out information as required, especially from the numerous sources available through the RMIT library, and through links and material specific to this course that is available through myRMIT Studies Course.


Overview of Learning Resources

RMIT will provide you with resources and tools for learning in this course through myRMIT Studies Course.

There are services available to support your learning through the University Library. The Library provides guides on academic referencing and subject specialist help as well as a range of study support services. For further information, please visit the Library page on the RMIT University website and the myRMIT student portal.


Overview of Assessment

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.  

Assessment Tasks

Assessment Task 1: Tutorial Activities
Weighting 20%
This assessment task supports CLOs 1, 2, 3, 4 & 5

Assessment Task 2: Mid-semester invigilated test (Modules 1-2)
Weighting 30%
This assessment task supports CLO 1 & 2

Assessment Task 3: Group project clinical trial proposal
Weighting 25%
This assessment task supports CLO 1, 2, 4 & 5

Assessment Task 4: Clinical Trial Report
Weighting 25%
This assessment task supports CLO 2, 3, 4 & 5

If you have a long-term medical condition and/or disability it may be possible to negotiate to vary aspects of the learning or assessment methods. You can contact the program coordinator or Equitable Learning Services if you would like to find out more.