Course coordinator
Dr Taskeen Janjua Khan
Course overview
- Study period
- Semester 1, 2025 (24/02/2025 - 21/06/2025)
- Study level
- Postgraduate Coursework
- Location
- External
- Attendance mode
- Online
- Units
- 2
- Administrative campus
- Dutton Park
- Coordinating unit
- Pharmacy and Pharmaceutical Sciences School
This course covers medicines regulation, clinical trial phases, designs and protocol development, along with trial governance, monitoring and audit. You will gain a comprehensive knowledge of Good Clinical Practice (GCP), the clinical and regulatory aspects of drug development, and the significance of risk management. You will also recognise the importance of the regulations in ensuring appropriate biometric data management and transparency of the drug development process.
This course is comprised of a series of seminars (2 x 2 hour sessions per week), associated self-directed learning delivered in our UQ Extend site, and a Learn.UQ site (Blackboard) that contains the assessment information and submission links. We start by covering the regulatory aspects around the clinical phase of medicines development and understanding the types and reasons for various trial designs that are used, before moving stepwise through developing and running a clinical trial considering the role of the Sponsor, trial site, and clinical research organisation. We also consider the role of trial participants in the development, design and contribution to clinical trials, with a particular focus on the distinct needs and contribution of Aboriginal and Torres Strait Islander peoples. We conclude the course with clinical trial reporting, interpreting published clinical trials, and considering some clinical development case studies. Experienced clinical trial researchers from academia and industry have contributed to the development of this course, and experts will be invited to join the sessions to reflect on their experiences in the clinical development pipeline and answer your questions.
Assessments run continuously throughout the course and are designed to contribute to your learning and provide ongoing feedback: this consists of short quizzes, a reflective piece, a written assignment and an oral presentation. To successfully complete this course it is important that you engage with the material consistently each week, and actively participate in the seminars.
Course requirements
Restrictions
MPharmIndPrac students only
Course contact
Lecturer
Dr Taskeen Janjua Khan
Course staff
Lecturer
Associate Professor Adam La Caze
Associate Professor Kathryn Steadman
Timetable
The timetable for this course is available on the UQ Public Timetable.
Additional timetable information
Please see Learn.UQ (Blackboard)ﾠfor the detailed timetable for this course. The timetable is subject to change to accommodate our industry experts who join us for the seminars.
Aims and outcomes
This course covers medicines regulation, clinical trial phases, designs and protocol development, along with trial governance, monitoring and audit. You will gain a comprehensive knowledge of Good Clinical Practice (GCP), the clinical and regulatory aspects of drug development, and the significance of risk management. You will also recognise the importance of the regulations in ensuring appropriate biometric data management and transparency of the drug development process.
Learning outcomes
After successfully completing this course you should be able to:
LO1.
Articulate the regulatory process as it applies to investigational, registered, and listed medicines in Australia
LO2.
Demonstrate understanding of and apply the principles of good clinical practice (GCP)
LO3.
Describe and differentiate clinical trial designs and phases of drug development
LO4.
Plan and evaluate the collection, management, and analysis of biometric data
LO5.
Identify potential risks and consider strategies to mitigate risk in clinical trials
LO6.
Describe the role for consumers in trial design and planning, emphasising the importance of diversity, and respecting the distinct needs and contribution of Aboriginal and Torres Strait Islander peoples
LO7.
Critically appraise clinical trial reporting
LO8.
Work effectively both independently and as a member of a team to present information in a written and oral format
LO9.
Use reflection as a process for recognising performance gaps and developing your skills and strategies
Assessment
Assessment summary
| Category | Assessment task | Weight | Due date |
|---|---|---|---|
| Quiz |
Series of quizzes
|
25% (5% each) |
Quiz 1: 14/03/2025 1:00 pm Quiz 2: 28/03/2025 1:00 pm Quiz 3: 11/04/2025 1:00 pm Quiz 4: 2/05/2025 1:00 pm Quiz 5: 16/05/2025 1:00 pm
Complete each quiz during the 7 days prior to the deadline. |
| Reflection |
Diversity and cultural practice in clinical trials
|
10% |
11/04/2025 1:00 pm |
| Paper/ Report/ Annotation |
Development of a clinical trial protocol
|
35% |
30/05/2025 1:00 pm |
| Presentation |
Critical appraisal
|
30% |
16/06/2025 1:00 pm |
Assessment details
Series of quizzes
- Online
- Mode
- Written
- Category
- Quiz
- Weight
- 25% (5% each)
- Due date
Quiz 1: 14/03/2025 1:00 pm
Quiz 2: 28/03/2025 1:00 pm
Quiz 3: 11/04/2025 1:00 pm
Quiz 4: 2/05/2025 1:00 pm
Quiz 5: 16/05/2025 1:00 pm
Complete each quiz during the 7 days prior to the deadline.
- Learning outcomes
- L01, L02, L03, L04, L05, L06, L08, L09
Task description
- Five quizzes will be delivered online via Learn.UQ (Blackboard).
- The link to each quiz will be available for 7 days, becoming available in Learn.UQ at 1 pm on the Friday of weeks 2, 4, 6, 8 & 10 and closing at 1 pm on Friday the following week (i.e. week 3, 5, 7, 9 & 11).
- You can take the quiz at any time during the period that the quiz is open
- Once you start the quiz you will have one hour to submit your answers; complete the quiz in one sitting.
- Each quiz contributes 5% of marks, your quiz results will be combined to produce the mark for this assessment item, contributing 25% of the overall course mark.
- The quiz is open-book, however the time allowed is unlikely to be enough for you look up the answer to every question, so it is important to revise the content of the previous two weeks prior to commencing the quiz.
- See Learn.UQ (Blackboard) for more information about each quiz and marking criteria.
- This task has been designed to be challenging, authentic and complex. Successful completion of the assessment will require students to critically engage in specific contexts and tasks for which artificial intelligence (AI) will provide only limited support and guidance.
Submission guidelines
The link to each quiz will be provided in Learn.UQ (Blackboard).
Deferral or extension
You may be able to apply for an extension.
The maximum extension allowed is 28 days. Extensions are given in multiples of 24 hours.
Late submission
A penalty of 10% of the maximum possible mark will be deducted per 24 hours from time submission is due for up to 7 days. After 7 days, you will receive a mark of 0.
Diversity and cultural practice in clinical trials
- Online
- Mode
- Written
- Category
- Reflection
- Weight
- 10%
- Due date
11/04/2025 1:00 pm
- Learning outcomes
- L06, L09
Task description
~We do not learn from experience; we learn from reflecting on experience~
- For this assessment you will complete UQ's online Cultural Safety in Practice Module 1.
- This assessment involves reflecting on your learning about the roles and contribution of diverse populations in clinical trials, with a particular emphasis on Aboriginal and Torres Strait Islander peoples of Australia.
- Consider your own identity - what are the key aspects of your personhood? That is, what makes you the person you are. How might (or does) your identity inform your professional practice? Compare and contrast this with the role of identity for those who identify as Aboriginal and/or Torres Strait Islander peoples.
- See Learn.UQ (Blackboard) for more information and the marking criteria for this activity.
- This assessment task evaluates your thoughts and knowledge without the aid of Artificial Intelligence (AI). Students are advised that the use of AI technologies to develop responses is strictly prohibited and may constitute student misconduct under the Student Code of Conduct.
Submission guidelines
Electronic submission of a Word document (.docx) via the link on Learn.UQ
Deferral or extension
You may be able to apply for an extension.
The maximum extension allowed is 28 days. Extensions are given in multiples of 24 hours.
Late submission
A penalty of 10% of the maximum possible mark will be deducted per 24 hours from time submission is due for up to 7 days. After 7 days, you will receive a mark of 0.
Development of a clinical trial protocol
- Mode
- Written
- Category
- Paper/ Report/ Annotation
- Weight
- 35%
- Due date
30/05/2025 1:00 pm
- Other conditions
- Student specific.
- Learning outcomes
- L02, L03, L04, L05, L08
Task description
For this assignment, imagine you are working in the medical writing department of a Sponsor or CRO. In this task you will create a protocol document following the SPIRIT 2013 checklist using the clinical trials registry information for an approved clinical trial.
- You will be given the clinical trials registry information for an approved trial.
- Using the SPIRIT protocol document provided here, you will transfer the information from the registry into the correct section in the SPIRIT document. It is acceptable to copy and paste information from the ANZCTR, trial website or participant information sheet - this content counts towards the first component of the marking criteria "core synopsis content collation".
- Use your knowledge from the topics covered during the course to suggest content for the other sections not covered by the registry information. For contributions towards the second component of the marking criteria "Research & develop content", it is important to write in your own words.
- Clearly differentiate the information derived from the registry from the information contributed by yourself by using different colours for the text.
- Your protocol document should be in the format of the SPIRIT checklist, do not rearrange the order.
- Include the 'Figure' (as it is called on the SPIRIT website), which is also called Schedule of Assessments - this is a table that shows what the participants will be doing in the trial.
- Include citations for any sources used to construct your contributions to the protocol.
- Format references using Vancouver style (as per the library guide) for in-text citations and the reference section.
Do not include:
- Section 2b - WHO list - do not include because it repeats everything that is in the rest of the SPIRIT checklist.
- Section 32 - Model consent form and other related documentation given to participants and authorised surrogates.
See Learn.UQ (Blackboard) for more information and the marking criteria for this activity.
This task has been designed to be challenging, authentic and complex. Whilst students may use Artificial Intelligence (AI) technologies, successful completion of assessment in this course will require students to critically engage in specific contexts and tasks for which artificial intelligence will provide only limited support and guidance. A failure to reference generative AI use may constitute student misconduct under the Student Code of Conduct. To pass this assessment, students will be required to demonstrate detailed comprehension of their written submission independent of AI tools.
Submission guidelines
Electronic submission of a Word document (.docx) via the link on Learn.UQ
Deferral or extension
You may be able to apply for an extension.
The maximum extension allowed is 28 days. Extensions are given in multiples of 24 hours.
Late submission
A penalty of 10% of the maximum possible mark will be deducted per 24 hours from time submission is due for up to 7 days. After 7 days, you will receive a mark of 0.
Critical appraisal
- Identity Verified
- Team or group-based
- Mode
- Oral, Product/ Artefact/ Multimedia
- Category
- Presentation
- Weight
- 30%
- Due date
16/06/2025 1:00 pm
- Other conditions
- Peer assessment factor.
- Learning outcomes
- L07, L08
Task description
You are to prepare a 12-minute presentation in which you critically appraise a published Phase 3 clinical trial study of a medicine that is currently registered in Australia.
Working in a group of 3 to 4 people, select a published article that describes the results of a Phase 3 clinical trial for a medicine that is currently registered in Australia. The trial can be conducted in any country but must be for a medicine that has an entry in the ARTG.
The presentation should contain the following elements:
- Research question, design and methods
- Explain the research study question(s) and why the study was required
- Explain and critically evaluate the research design and methods using the PICO framework. For example, consider whether the comparator is the most appropriate, whether the masking could be improved.
- Results and limitations
- Describe the results and what the statistical analysis means. For example, you might refer to the P value, confidence interval, hazard ratio, and calculate the relative risk reduction and absolute risk reduction, and number needed to treat. Consider whether the results answer the research study’s questions, do the results show statistical significance, do the results show clinical significance?
- Explain any limitations and how they impact on application of the study's findings.
- Consider the potential for conflict of interest amongst those running or funding the study. For example, profile the pharmaceutical company that markets the medicine (e.g. product range, financial position, historical misconduct) and consider whether there is any link between the authors and the pharmaceutical company that markets the medicine.
- Note that citations should be given for any source of information used to inform the presentation, except for the paper itself and PHIP7141 seminar notes or UQ Extend content. Citations can be written in small font on the relevant slide, or on a slide at the end of the presentation.
See Learn.UQ (Blackboard) for more details and the marking criteria.
This task has been designed to be challenging, authentic and complex. Whilst students may use Artificial Intelligence (AI) technologies, successful completion of assessment in this course will require students to critically engage in specific contexts and tasks for which artificial intelligence will provide only limited support and guidance. A failure to reference generative AI use may constitute student misconduct under the Student Code of Conduct. To pass this assessment, students will be required to demonstrate detailed comprehension of their written submission independent of AI tools.
Submission guidelines
You have two options for submission, pick either option 1 or 2:
- Upload a video recording of your presentation to Learn.UQ (Blackboard) by the deadline. You can use any technology you like, there are no restrictions, as long as your face is visible throughout your presentation. For example, you could open Zoom, share your PowerPoint slides, have your camera on, and record the presentation to your computer. You could record your presentation using PowerPoint's 'voice over PowerPoint' feature to create a video. Or you might record on your iPhone mounted to a selfie stick with sheets of paper showing your major points. You can upload the recording itself, or you can publish to YouTube (visible to only those with the link) and insert the video link as the upload in Blackboard. You can be as creative as you like, just make sure that you consider the marking criteria.
- Give your presentation live or via Zoom to your course coordinator on the day following the submission deadline. Please let the course coordinator know if you choose this option so that a presentation schedule can be arranged between 11 am and 4 pm. Any student not submitting their video by the submission deadline will be automatically allocated an in-person presentation slot. These presentations will be recorded.
Deferral or extension
You may be able to apply for an extension.
The maximum extension allowed is 28 days. Extensions are given in multiples of 24 hours.
You can request an extension on behalf of your group for a group assessment item, provided that at least 50% of your group members also agree to the request for an extension. Download and complete the form below, and attach this form to your extension request: Extension of Group Assessment - Group Member Acknowledgement (PDF, 144.9 KB)
Late submission
You will receive a mark of 0 if this assessment is submitted late.
Course grading
Full criteria for each grade is available in the Assessment Procedure.
| Grade | Cut off Percent | Description |
|---|---|---|
| 1 (Low Fail) | 1 - 29 |
Absence of evidence of achievement of course learning outcomes. |
| 2 (Fail) | 30 - 44 |
Minimal evidence of achievement of course learning outcomes. |
| 3 (Marginal Fail) | 45 - 49 |
Demonstrated evidence of developing achievement of course learning outcomes |
| 4 (Pass) | 50 - 64 |
Demonstrated evidence of functional achievement of course learning outcomes. |
| 5 (Credit) | 65 - 74 |
Demonstrated evidence of proficient achievement of course learning outcomes. |
| 6 (Distinction) | 75 - 84 |
Demonstrated evidence of advanced achievement of course learning outcomes. |
| 7 (High Distinction) | 85 - 100 |
Demonstrated evidence of exceptional achievement of course learning outcomes. |
Supplementary assessment
Supplementary assessment is available for this course.
Learning resources
You'll need the following resources to successfully complete the course. We've indicated below if you need a personal copy of the reading materials or your own item.
Library resources
Find the required and recommended resources for this course on the UQ Library website.
Learning activities
The learning activities for this course are outlined below. Learn more about the learning outcomes that apply to this course.
Filter activity type by
Please select
| Learning period | Activity type | Topic |
|---|---|---|
Multiple weeks From Week 1 To Week 2 |
Seminar |
Regulatory environment and GCP There are two x 2-hour seminars scheduled each week. Week 1-2: Regulation of medicines and good clinical practice (GCP). Learning outcomes: L01, L02, L08, L09 |
Multiple weeks From Week 1 To Week 12 |
Not Timetabled |
UQ Extend content and readings You are expected to prepare for the seminars by reading through content and completing the online learning activities on the UQ Extend site for this course each week. This will enable you to engage more fully with the teachers and industry experts who join you during the seminars. Learning outcomes: L01, L02, L03, L04, L05, L06, L07 |
Multiple weeks From Week 3 To Week 5 |
Seminar |
Clinical trials - planning There are two x 2-hour seminars scheduled each week. Week 3-5: Clinical trial phases and designs, including adaptive and hybrid designs, N-of-1 designs, and bioequivalence studies. Learning outcomes: L03, L04, L08 |
Week 6 (31 Mar - 06 Apr) |
Seminar |
Putting patients first There are two x 2-hour seminars scheduled each week. Week 6: Consider the roles for consumers in trials, and the importance of putting patients first in the development and design of trials. You will complete an online learning module "Cultural Safety in Practice Module 1" to help you understand the history of Australia's first peoples. We will consider the value of diversity in consumer background in the clinical trial space. Learning outcomes: L04, L05, L06, L08, L09 |
Multiple weeks From Week 7 To Week 10 |
Seminar |
Clinical trials - running There are two x 2-hour seminars scheduled each week. Week 7-10: Moving stepwise through running clinical trials, from clinical development plan through site selection, trial registration, protocol development, governance, essential documentation, monitoring and audit, data management and site/trial close down. Learning outcomes: L04, L05, L06, L08 |
Multiple weeks From Week 11 To Week 12 |
Seminar |
Clinical trials - reporting There are two x 2-hour seminars scheduled each week. Week 11-12: Using case studies, consider clinical trial reporting and interpretation. Learning outcomes: L07, L08 |
Policies and procedures
University policies and procedures apply to all aspects of student life. As a UQ student, you must comply with University-wide and program-specific requirements, including the:
- Student Code of Conduct Policy
- Student Integrity and Misconduct Policy and Procedure
- Assessment Procedure
- Examinations Procedure
- Reasonable Adjustments - Students Policy and Procedure
Learn more about UQ policies on my.UQ and the Policy and Procedure Library.