HLTH SC 3101 - Clinical Trials Management: Principles and Practice
North Terrace Campus - Semester 2 - 2023
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General Course Information
Course Details
Course Code HLTH SC 3101 Course Clinical Trials Management: Principles and Practice Coordinating Unit Medical Sciences Term Semester 2 Level Undergraduate Location/s North Terrace Campus Units 3 Contact Up to 4 hours per week Available for Study Abroad and Exchange N Prerequisites HLTH SC 2104 or PUB HLTH 2007 or MEDIC ST 1000B Assumed Knowledge PUB HLTH 3009 Assessment Students will complete individual assignments, group study management plan and presentation, participate in tutorials and engage in workshops. There will be both a mid-semester examination and an end of course examination. Course Staff
Course Coordinator: Professor Sepehr Shakib
Course Timetable
The full timetable of all activities for this course can be accessed from .
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Learning Outcomes
Course Learning Outcomes
On successful completion of this course students will be able to: 1 Interpret the principles of Good Clinical Practice, and be able to apply these in practice 2 Cite the regulatory and reporting requirements for critical aspects of clinical trials 3 Articulate critical aspects of informed consent in the clinical trial setting 4 Categorise adverse events correctly 5 Create a patient information sheet from a clinical trial protocol 6 Summarise critical aspects of trial monitoring
University Graduate Attributes
This course will provide students with an opportunity to develop the Graduate Attribute(s) specified below:
University Graduate Attribute Course Learning Outcome(s) Attribute 1: Deep discipline knowledge and intellectual breadth
Graduates have comprehensive knowledge and understanding of their subject area, the ability to engage with different traditions of thought, and the ability to apply their knowledge in practice including in multi-disciplinary or multi-professional contexts.
1-6 Attribute 2: Creative and critical thinking, and problem solving
Graduates are effective problems-solvers, able to apply critical, creative and evidence-based thinking to conceive innovative responses to future challenges.
1-6 Attribute 3: Teamwork and communication skills
Graduates convey ideas and information effectively to a range of audiences for a variety of purposes and contribute in a positive and collaborative manner to achieving common goals.
1-6 Attribute 4: Professionalism and leadership readiness
Graduates engage in professional behaviour and have the potential to be entrepreneurial and take leadership roles in their chosen occupations or careers and communities.
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Learning Resources
Required Resources
Keech A, Gebski V, Pike R (eds). Interpreting and reporting Clinical Trials: A guide to the CONSORT statement and the principles of randomised controlled trials. Australasian Medical Publishing Company, 2007Recommended Resources
Students will be able to open access a variety of third party online resources for clinical trials management e.g. NHMRC, ANZCTR. Links to journal articles and reading lists disseminated via MyUni.Online Learning
The primary means of communication outside of the formal contact hours will be via MyUni. Announcements will be used as the main method of communicating with the student cohort. Course material will be supported by online resources, with lecture recordings available via MyUni. Material will be sequentially released in line with the teaching and learning activities in each week or at the beginning of the Semester. -
Learning & Teaching Activities
Learning & Teaching Modes
There will be a number of small online modules to provide basic definitions for some of the content which is repeated throughout the course eg adverse effect, protocol, investigator brochure, Good Clinical Practice.
Other content may be delivered as online modules, which the students will learn at their own pace.
There are 2 lectures per week which may be face to face or presented online to provide the core course didactic content.
There are 9 small group discovery experiences where students will work together to discus and will develop clinical trial protocols based on information provided to them on hypothetical drugs, and will work through Good Clinical Practice. Students will also be expected to work together in groups, outside of these sessions, to complete a workbook in lieu of face to face workshops.Workload
The information below is provided as a guide to assist students in engaging appropriately with the course requirements.
Students will be expected to watch 2 lectures, take part in an hour long workshop every week and complete online quizzes nearly every week.
Students will also be expected to spend approximately 1-2 hours per week working as a group on developing study protocols.Learning Activities Summary
The bulk of the learning will be through the workshops where students will be facilitated to work together to create clinical trial protocols for their hypothetical drugs. These will be supported by lectures (delivered by experts from industry) and problem-solving tutorials. -
Assessment
The University's policy on Assessment for Coursework Programs is based on the following four principles:
- Assessment must encourage and reinforce learning.
- Assessment must enable robust and fair judgements about student performance.
- Assessment practices must be fair and equitable to students and give them the opportunity to demonstrate what they have learned.
- Assessment must maintain academic standards.
Assessment Summary
Active participation - 10%
Online quizzes at the end of each workshop regarding content covered- 5 X 10%
Mid-semester exam- 15%
Final exam- 25%Assessment Detail
The individual assignments consist of specific tasks related to the clinical trial protocol which will be developed by the group eg development of consent from from protocol, development of schedule of events from protocol, determination of inclusion/exclusion criteria, writing a study synopsis, writing data collection tool for specific protocol events eg screening visit. These will be submitted by individual students with different students taking on the different tasks in the creation of the protocol.
There will be 1 assignment submitted and will account for 15% of the total marks.
Through the workshops the group of students will also work together to create two study protocols. These will be presented to a panel including academics, members of an ethics committee, and industry representatives, who will assess the study designs. This group mark will contribute to 25% of each student's mark.Submission
Assignments should be submitted online through MyUni. Assignments must be submitted by 11:59pm on the due date.
All assignments must be scanned and submitted electronically (as word or pdf documents).
Extensions
All extensions for assignments must be requested, at the latest, by the last working day before the due date of submission. Extensions will generally be granted only on medical or genuine compassionate grounds. Supporting documentation must be provided at the time a student requests an extension. Without documentation, extensions will not be granted. Late requests for extension will neither be accepted nor acknowledged.
Late submission
Marks will be deducted when assignments for which no extension has been granted are handed in late.
All assignments, including those handed in late, will be assessed on their merits. In the case of late assignments where no extension has been granted, 5 percentage points of the total marks possible per day will be deducted. If an assignment that is 2 days late is awarded 65% on its merits, the mark will then be reduced by 10% (5% per day for 2 days) to 55%. If that same assignment is 4 days late, the mark will be reduced by 20% (5% per day for 4 days) to 45%, and so on.
Students submitting examinable written work who request (and receive) an extension that takes them beyond the examination period are advised that there is no guarantee that their grades will be processed in time to meet usual University deadlines.
Resubmission
If a student is dissatisfied with an assessment grade they should follow the Student Grievance Resolution Process </student/grievance/>. Students who are not satisfied with a particular assessment result should raise their concerns with Course Co-ordinator(s) in the first instance. This must be done within 10 business days of the date of notification of the result. Resubmission of any assignment is subject to the agreement of the Course Co-ordinator(s) and will only be permitted for the most compelling of reasons.Course Grading
Grades for your performance in this course will be awarded in accordance with the following scheme:
M10 (Coursework Mark Scheme) Grade Mark Description FNS Fail No Submission F 1-49 Fail P 50-64 Pass C 65-74 Credit D 75-84 Distinction HD 85-100 High Distinction CN Continuing NFE No Formal Examination RP Result Pending Further details of the grades/results can be obtained from Examinations.
Grade Descriptors are available which provide a general guide to the standard of work that is expected at each grade level. More information at Assessment for Coursework Programs.
Final results for this course will be made available through .
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Student Feedback
The University places a high priority on approaches to learning and teaching that enhance the student experience. Feedback is sought from students in a variety of ways including on-going engagement with staff, the use of online discussion boards and the use of Student Experience of Learning and Teaching (SELT) surveys as well as GOS surveys and Program reviews.
SELTs are an important source of information to inform individual teaching practice, decisions about teaching duties, and course and program curriculum design. They enable the University to assess how effectively its learning environments and teaching practices facilitate student engagement and learning outcomes. Under the current SELT Policy (http://www.adelaide.edu.au/policies/101/) course SELTs are mandated and must be conducted at the conclusion of each term/semester/trimester for every course offering. Feedback on issues raised through course SELT surveys is made available to enrolled students through various resources (e.g. MyUni). In addition aggregated course SELT data is available.
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Student Support
- Academic Integrity for Students
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Policies & Guidelines
This section contains links to relevant assessment-related policies and guidelines - all university policies.
- Academic Credit Arrangements Policy
- Academic Integrity Policy
- Academic Progress by Coursework Students Policy
- Assessment for Coursework Programs Policy
- Copyright Compliance Policy
- Coursework Academic Programs Policy
- Intellectual Property Policy
- IT Acceptable Use and Security Policy
- Modified Arrangements for Coursework Assessment Policy
- Reasonable Adjustments to Learning, Teaching & Assessment for Students with a Disability Policy
- Student Experience of Learning and Teaching Policy
- Student Grievance Resolution Process
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