Course Title: Clinical Trial Design and Management

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

Course Coordinator: Dr Paul Bertrand

Course Coordinator Phone: +61 3 9925 7898

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

Course Coordinator Location: 223.2A.004

Course Coordinator Availability: By appointment only


Pre-requisite Courses and Assumed Knowledge and Capabilities

Required prior study (Pre-requisites)


Course Description

The course will provide an understanding of the drug development process in human volunteers and patients, that follows pre-clinical safety and toxicity studies in animals. The emphasis will be 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
    Adapt knowledge, concepts and skills to problem solve (PLO 2)
  • Communication and Teamwork
    Develop skills to effectively communicate, both orally and written (PLO 3)
  • Investigation and Analysis
    Apply initiative and judgement and adapt knowledge and skills (PLO 4)


On successful completion of this course you should be able to:

  1. demonstrate an understanding of clinical trials, including the 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 and by so doing ensure that the course is relevant to the workplace, thus enhancing the employability of graduates.

You will undertake the equivalent of two hours per week in lectures, one hour of tutorial per week and one hour of workshop per week.

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), Lectopia recordings or short videos of lecture presentations and tutorial classes. The course site in myRMIT provides opportunities for students to access much of this material and use asynchronous discussions as an additional mode of learning. Students will also be expected to download peer-reviewed articles and references from the internet


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 examinations 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.

Please note that in each two week study module you will take short review quizzes in order to gain experience in answering questions similar to those you will answer in the formal tests outlined above. These tests are not for marks.

Note that:

This course has no hurdle requirements.

Assessment Tasks

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 CLOs1

Assessment Task 1:  Tutorial activities

Weighting 10%

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

Assessment Task 2: Formal assessments

Weighting 65%

This assessment task supports CLOs 1, 3 & 4

Assessment Task 3: Clinical trial proposal (Group)

Weighting 10% 

This assessment supports CLO 2

Assessment Task 4: Clinical trial research report (Individual)

Weighting 15% 

This assessment supports CLOs 2, 3 & 4