96066 Clinical Trials Quality Assurance Management
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Subject handbook information prior to 2024 is available in the Archives.
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 Medicines 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.
On-campus (standard) mode: This subject is normally delivered on the City campus and requires attendance for three hours of face-to-face contact per week, as well as approximately 1-3 hours of personal study pre-work before each class. However, should restrictions related to COVID-19 require it, classes for this subject will be conducted online. The format and content of online classes (should they be required) will be equivalent to face to face on-campus classes and the same attendance requirements apply.
Online (distance) mode: This subject is delivered online via Canvas. Students are required to contribute to weekly discussions as well as participate in occasional online meetings via zoom when required. Students should dedicate approximately 3-6 hours of time to this subject per week. Students will learn in this subject through online content comprising videos, set reading, directed research activities, online discussions and self-check quizzes. This independent learning will be supported by group learning experiences, in which ideas and concepts can be tested and refined.
Strategy 1: Student-directed learning: Students read articles and use online resources, such as online course material, videos, directed research, activities, self-check quizzes and case studies, provided via Canvas. This learning prepares students for their participation in activities that may include facilitated discussion of fundamental concepts drawn from course materials and solutions to industry case studies, assessable quizzes or activities as well as collaborative and interactive learning experiences.
Strategy 2: Collaborative and interactive learning experiences: Provide the students with the opportunity to engage with Peers and Academics to discuss and clarify concepts for a deeper understanding of online course materials.
On-campus students - engage in a weekly 3-hour workshop. Each workshop aims to apply online course materials to real-life pharmaceutical industry scenarios through discussions and problem-solving in collaboration with fellow students.
Online students – engage in weekly discussion forums. Each online discussion aims to apply course material in real-life pharmaceutical industry scenarios and collaboration with fellow students is required by posting and responding to other students posts in the discussion forum. Students participate in the online discussions by writing their comments in the Canvas platform in their own time and also read and respond to posts from peers. Each discussion has an end time designated by which students must have contributed.
Strategy 3: Early and consistent feedback: Early feedback is provided prior to the census date. On-campus students – receive feedback in workshops or via the Canvas platform for activities. Feedback regarding the quizzes is provided following each quiz, via provision of answers and/or in-class review. The collaborative learning approach utilised in class will enable ongoing feedback to be provided in class, as areas of learning need are identified through class discussions. Online students – receive feedback during ‘open office’ hours and discussion forums. Feedback regarding the self-check quizzes is provided via Canvas immediately upon submission of each quiz. The collaborative learning approach will enable ongoing feedback to be provided to students, via teacher responses to posts, as areas of learning need are identified through online discussions.
Strategy 4: Group work: students work in groups during collaborative and interactive experiences. Students will need to coordinate group work, fostering negotiation, team building and teamwork skills. Students will need to demonstrate the ability to respond respectfully and constructively to their peers, fostering communication, constructive criticism and respect for diverse ways of working.
Strategy 5: Students are encouraged to critically reflect on their learning throughout the subject to identify areas where they may improve their performance and develop lifelong learning 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: On-going Graded Assessment
| Intent: | Throughout the semester you will have the opportunity to check your understanding of the course content via graded assessments through the Canvas platform. |
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| Objective(s): | This task is aligned with the following subject learning objectives: 036, 037, 038 and 039 This task is aligned with the following course learning outcomes: 01.09, 02.01, 02.02, 02.03, 02.04, 02.05, 02.08 and 03.11 |
| Groupwork: | Individual |
| Weight: | 15% |
| Criteria: | Tasks are marked online or by the teacher according to the specific requirements of each task. The tasks are designed to allow assessment of the student’s ability to apply and evaluate the principles taught. |
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: | 25% |
| Length: | 2-3 pages |
| 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
On Campus Mode
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
Online Mode
In order to pass this Subject, a minimum grade of 50% must be achieved and students must 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)