96066 Clinical Trials Quality Assurance Management
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Credit points: 6 cp
Result type: Grade and marks
Requisite(s): 96057 GMP for Manufacturing Operations AND 96134 Validation Principles and Practices AND 96059 International GMPs and Quality Assurance AND 96060 Good (Quality Control) Laboratory Practices AND 96069 Contamination Control AND 96062 Good Aseptic Practices and Sterile Products AND 96063 GxP and Quality Auditing Practices AND 96064 Risk Management for Pharmaceutical Operations
There are course requisites for this subject. See access conditions.
Description
Clinical trials are research studies on human subjects, necessary for determining the safety and effectiveness of medical treatments, devices or approaches. Such studies must adhere to strict guidelines as provided by the regulatory bodies in various regions such as Australia (Therapeutic Goods Administration), the US (Food and Drug Administration) and Europe (European Medical Agency).
This subject introduces the regulation and protocols for clinical trial programs required both nationally and globally. Clinical trial design and project management in the context of new product development is introduced. Students develop a solid understanding of clinical trial design ranging from protocols to recruitment, initiation of studies, data collection and management. It also encompasses the auditing requirements for the manufacture of clinical materials and clinical protocols.
Subject learning objectives (SLOs)
| 036. | Evaluate the different regulatory pathways and critical success factors of pharmaceutical product approval in multiple regulatory environments |
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| 037. | Contrast the regulation and enforcement of clinical trials in Australia, the USA and the EU |
| 038. | Identify data required to demonstrate Good Clinical Practice (GCP) compliance at all stages of a clinical trial |
| 039. | Justify the differing GMP requirements for clinical material and commercial material |
| 040. | Create a quality plan for a clinical trial using knowledge of regulatory requirements, GCP principles and risk evaluation techniques. |
| 041. | Design a clinical trial audit and a specific audit checklist relevant to the quality plan |
| 042. | Prepare a Standard Operating Procedure for conducting Clinical Trial Program audits |
| 043. | Explain how subjects’ rights are protected in a GCP-compliant study |
Course intended learning outcomes (CILOs)
The learning outcomes for this subject are as follows:
- Reflect on the knowledge, skills and attributes required for the evaluation and integration of emerging evidence into practice, promoting the growth of personal and professional learning, and the education of others. (01.09)
- Demonstrate accurate and comprehensive knowledge of risk management practices and models, and implement and evaluate them in a range of contexts. (02.01)
- Test, audit and validate pharmaceuticals manufacturing and distribution processes using appropriate methodologies. (02.02)
- Design, implement and evaluate control systems for pharmaceuticals manufacturing. (02.03)
- Demonstrate ethically and legally accountable approaches to pharmaceuticals manufacturing and control. (02.04)
- Analyse and synthesise knowledge of relevant concepts and theory, and apply skills of scientific research and reasoning to support Good Manufacturing Practice. (02.05)
- Produce accurate technical documentation, and communicate effectively and accurately with clients and stakeholders in written or spoken language appropriate to their needs. (02.06)
- Contribute as leader and collaborator in the assurance of Good Manufacturing Practice. (02.08)
- Collaborate effectively with other professions to ensure Good Manufacturing Practice. (02.10)
- Demonstrate knowledge of Good Manufacturing Practice in local, national and global contexts. (03.11)
Contribution to the development of graduate attributes
This Subject provides an understanding of clinical trial development, management and assessment. The implications and safety issues associated with breached quality guidelines emphasises the necessity for good quality practices in the health industry.
Lifelong learning:
Graduates of the Master of GMP are lifelong learners, committed to and capable of reflection and inquiry in their quest for personal development and excellence in professional practice.
Professional capacity:
Graduates of the Master of GMP are industry-focussed, ethical practitioners with the understanding and proficiency to be leaders in their profession, capable of effectively analysing and implementing solutions in a global context.
Global citizenship
Graduates of the Master of Good Manufacturing Practice contribute to society, resolving to undertake those actions and responsibilities that will enhance their role in local, national and global communities.
Teaching and learning strategies
Good Clinical Practice plays a pivotal role assessing the safety and effectiveness of pharmaceutical products for unmet medical needs. This subject focuses on the critical practices within a pharmaceutical clinical trial domain under global regulations. Lectures and workshops will provide relevant knowledge and theoretical underpinnings.
Contact meetings for this subject will now be conducted online until further notice. There will be no face-to-face or on-campus classes for this subject. Online meetings via video conferencing will be conducted each week comprising small group workshops to learn the application of class materials. The format and content of these classes will be equivalent to face to face on-campus classes. Students are expected to complete personal study via the Canvas platform each week as preparation for class. It is expected that all students participate in the set activities during the scheduled time-slot for class. Attendance rolls will be marked.
Workshops provide an opportunity to apply lecture content to simulated real life pharmaceutical industry situations.
Strategy 1: Student preparation for learning: Students read articles and news items, watch videos relevant to clinical trials, follow regulatory updates and notices as well as use of online resources, such as online lecture notes and case studies provided via Canvas. Students prepare for their participation in activities including facilitated discussion of solutions to industry case studies, class quizzes, and collaborative discussion of fundamental concepts drawn from lectures and international regulatory guidelines and practices.
Strategy 2: Active lectures: Lectures are a key learning resource in this subject. Attending lectures is crucial to a full understanding of the subject content. The lectures will involve collaborative questions and class discussions of the pertinent points. These questions will help to keep students engaged throughout the session. There will be 1 hour of lecture each week. Notes corresponding with each lecture are uploaded to Canvas.
Strategy 3: Collaborative and interactive learning in workshops: Workshops provide students with an opportunity to discuss and clarify concepts from the lectures, thus providing the students the opportunity for deeper understanding. Each workshop aims to apply lecture contents in real life pharmaceutical industry scenarios and collaboration with fellow students is encouraged. Students will engage in group discussions and problem solving. There will be 1 hour of workshop each week.
Strategy 4: Early and consistent feedback: Early feedback is provided face to face prior to the census date during lectures and workshops. Feedback regarding the quizzes is provided following each quiz, and also individually during workshop discussions. The collaborative learning approach utilised in class will enable ongoing feedback to be provided either in class or online, as areas of learning need are identified through class discussions.
Strategy 5: Group work: students work in groups on their group assignment, and workshop sessions. Students will need to coordinate group work and meetings outside of class time, fostering negotiation, team building and teamwork skills.
Content (topics)
Firstly you will learn about product development in a regulated environment including the regulatory framework, differences in pathways to pharmaceutical product approval between the USA, Europe and Australia and critical success factors for commercialisation. You will next learn about the different types and phases of clinical trials before stepping through planning, monitoring and reporting processes. Next you will learn about clinical data collection and records management and the various requirements that are enforced by regulators. In conclusion, you will revisiting lessons from other MGMP subjects and learn about manufacture, control and distribution as well as auditing and vendor assurance in the clinical space; and how this compares to the commercial space.
Assessment
Assessment task 1: Quiz
| Intent: | Consolidate the early lessons from this subject and provide early feedback on your understanding of product development in a regulated environment. This assessment task is designed for you to compare and contrast the various approval processes within various regulatory regions, for example USA, EU and Australia. |
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| Objective(s): | This task is aligned with the following subject learning objectives: 036 and 037 This task is aligned with the following course learning outcomes: 01.09, 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.10 and 03.11 |
| Type: | Quiz/test |
| Groupwork: | Individual |
| Weight: | 10% |
| Length: | 30 minutes |
| Criteria: | Provided via Canvas |
Assessment task 2: Fundamental Concepts in Clinical Trials
| Intent: | This assessment gives you the opportunity to demonstrate your understanding of some fundamental concepts in clinical trials. The focus is on ethical considerations, clinical trial application processes and the requirements for essential documents. |
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| Objective(s): | This task is aligned with the following subject learning objectives: 036, 037 and 043 This task is aligned with the following course learning outcomes: 01.09, 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.10 and 03.11 |
| Type: | Report |
| Groupwork: | Individual |
| Weight: | 30% |
| Length: | 1000 to 1500 words |
| Criteria: | Provided via Canvas |
Assessment task 3: Quality Plan for the conduct of a Clinical Trial
| Intent: | This assessment gives you the opportunity to demonstrate your understanding of clinical trial planning in a regulated environment. This will focus on critical aspects that companies and regulators must be cognisant of; in order to achieve compliance in a simulated real-life pharmaceutical scenario. |
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| Objective(s): | This task is aligned with the following subject learning objectives: 038 and 040 This task is aligned with the following course learning outcomes: 01.09, 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.10 and 03.11 |
| Type: | Project |
| Groupwork: | Individual |
| Weight: | 30% |
| Length: | 15-20 pages in total using the template provided |
| Criteria: | Provided via Canvas |
Assessment task 4: Clinical Trial Auditing Project
| Intent: | Moving further down the event chain from assessment task 2, this assignment is designed to help you explore your understanding of clinical trial implementations, how to comply with Quality Plans while also extending into the more technical details of audits and procedures. Students follow established international guidelines in this audit program. |
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| Objective(s): | This task is aligned with the following subject learning objectives: 041 and 042 This task is aligned with the following course learning outcomes: 01.09, 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.08, 02.10 and 03.11 |
| Type: | Project |
| Groupwork: | Group, individually assessed |
| Weight: | 30% |
| Length: | Audit Plan: 4-5 pages Audit Checklist: 2-3 pages SOP: 4-6 pages. |
| Criteria: | Provided via Canvas |
Minimum requirements
In order to pass this Subject, a minimum grade of 50% must be achieved.
Students are required to attend a minimum of 85% of classes, and submit all assessment tasks.
Required texts
Provided via the subject Canvas site
Coursework Assessments Procedures
Graduate School of Health Policy, Guidelines and Procedures (login required)