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Clinical Trials Quality Assurance Management

Unit Code: HES6414

Duration

Contact Hours

Campus

Prerequisite

Corequisite

1 Semester or Teaching Period

30 Hours

External Venue, Hawthorn

Nil, however a basic understanding of, GMP and practical work experience within the industry is assumed. Completion, or co-completion, of HES6401, HES6402and HES6403 is therefore desirable.

HES6401 International Good Manufacturing Practices and Quality Assurance

HES6402 Good Manufacturing Practices for Manufacturing Operations

HES6403 Validation Principles

Credit Points: 12.5 Credit Points

Related Course/s:

An elective unit of study in the Graduate Certificate of Science (Good Manufacturing Practices), Graduate Diploma of Science (Good Manufacturing Practices), Master of Science (Good Manufacturing Practices) and Master of Science (Good Manufacturing Practices) (Honours).

Aims & Objectives:

This unit aims to expand upon the material taught in HES6410 to cover GMP aspects of clinical trials. At the end of this unit of study students will be able to:

Introduction to GCP

Have an appreciation for international Regulations and Protocols for GCP activities.
Briefly explain Phases I, II, III and IV.
Have an appreciation for FDA and TGA Requirements.

New Product Development and GxP Regulations

Discuss the CTN/CTX and IND Approval schemes.
Have an overview of project management for product development and clinical programs.
Demonstrate key checkpoints in product development for clinical trials.

Clinical Programs – Protocols, Recruitment, Initiation, Assessment & Management

State the key requirements of GCP.
Document what is required for data collection, records control, QA reviews and storage/archiving.

Product Manufacture and Distribution

List the key GMP requirements for the manufacture of materials for clinical trials.
Define the terms 'blinding' and 'randomisation' as they relate to clinical trials.
List the key GMP requirements for the labelling and packaging of materials for clinical trials.
Identify potential sources of errors and mix ups in the distribution of material for clinical trials and list strategies to prevent their occurrence.

Auditing Clinical Protocols and Trials

Understand the requirements for QA Auditing of Clinical Trials.
Prepare patient report reviews.
Have exposure to investigations and data reviews.

Teaching Methods:

Lectures/Tutorials, Laboratory and/or experiential off-campus learning, Case studies based on actual events that have occurred in the pharmaceutical and related industries will be used, Web Based Unit Presence (Blackboard).

Assessment:

Assignments (40%)
Test (20%)
Portfolio (10%)
Examination (30%)

Generic Skills Outcomes:

Students will be provided with feedback during the assessment for this unit of study on their progress in attaining the following generic skills:

Teamwork skills,
Analysis skills,
Problem solving skills,
Communications skills,
Ability to tackle unfamiliar problems, and the
Ability to work independently

Content:

Introduction to GCP: This module introduces international regulations and protocols for GCP activities, FDA and TGA requirements.

New Product Development and GxP Regulations: This module gives an overview of project management in the context of new product development and GxP regulations.

Clinical Programs – Protocols, Recruitment, Initiation, Assessment & Management: This module details protocols etc. required for clinical programs including data collection and records control.

Auditing Clinical Protocols and Trials: This module introduces auditing requirements for clinical trials.

Reading Materials:

Lecture notes (provided via Blackboard)

Textbooks:

Printed notes will be supplied