Course Title: Clinical Trial Design and Management

Part A: Course Overview

Course Title: Clinical Trial Design and Management

Credit Points: 12.00

Important Information:

To participate in any RMIT course in-person activities or assessment, you will need to comply with RMIT vaccination requirements which are applicable during the duration of the course. This RMIT requirement includes being vaccinated against COVID-19 or holding a valid medical exemption. 

Please read this RMIT Enrolment Procedure as it has important information regarding COVID vaccination and your study at RMIT: https://policies.rmit.edu.au/document/view.php?id=209

Please read the Student website for additional requirements of in-person attendance: https://www.rmit.edu.au/covid/coming-to-campus 


Please check your Canvas course shell closer to when the course starts to see if this course requires mandatory in-person attendance. The delivery method of the course might have to change quickly in response to changes in the local state/national directive regarding in-person course attendance. 



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

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 (Pre-requisites)

OR


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 successful 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 and report on 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
  5. work effectively in a team environment


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 three hours of lecture and one hour of tutorial.

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: http://rmit.libguides.com/biomedical-science


Overview of Assessment

This course has no hurdle requirements.

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

Assessment Task 2: Mid-semester take-home assignment (Modules 1-2)

Weighting 20%

This assessment task supports CLO 1, 3 & 4

Assessment Task 3: End-of-semester take-home assignment (Modules 3-4)

Weighting 20%

This assessment task supports CLO 1, 3 & 4

Assessment Task 4: Clinical trial project

Weighting 40%

This assessment task supports CLO 2, 3, 4 & 5