HLTH SC 3101 - Clinical Trials Management: Principles and Practice

North Terrace Campus - Semester 2 - 2024

This course will teach the practical aspects of clinical trial conduct such as synopsis and protocol writing, principles of informed consent, study conduct and follow up, adverse event reporting, report writing, as well as the principles of Good Clinical Practice. This will be done within the regulatory and reporting framework for clinical trials.

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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 Course Planner.

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	Summarise the regulatory requirements for clinical trials including the roles of ethics and governance
3	Articulate critical aspects of informed consent in the clinical research setting
4	Summarise importance of adverse event documentation in clinical research
5	Create a user friendly and Good Documentation Practice compliant case report form (CRF)
6	Illustrate critical aspects of trial monitoring
7	Interpret or design different components of a clinical trial protocol

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.	3, 5, 6, 7
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.	3, 5, 6, 7
Attribute 5: Intercultural and ethical competency Graduates are responsible and effective global citizens whose personal values and practices are consistent with their roles as responsible members of society.	1, 3, 4
Attribute 6: Australian Aboriginal and Torres Strait Islander cultural competency Graduates have an understanding of, and respect for, Australian Aboriginal and Torres Strait Islander values, culture and knowledge.	2
Attribute 7: Digital capabilities Graduates are well prepared for living, learning and working in a digital society.	5, 7
Attribute 8: Self-awareness and emotional intelligence Graduates are self-aware and reflective; they are flexible and resilient and have the capacity to accept and give constructive feedback; they act with integrity and take responsibility for their actions.	3, 4, 5, 7

Learning Resources

Required Resources

There are really no required resources for this course. Appropriate online and other resources will be provided during the teaching

Recommended 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

The content is taught in a variety of different modes to give students the opportunity to engage with the content and completed the learning objectives.

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.

There are 2 lectures per week which may recorded or presented online by industry representatives to provide the core course didactic content.

There are up to 9 small group discovery experiences where students will work together to apply the learnings from the online lectures to practical aspects of clinical trials.
These will involve workshops on:
- Good Clinical Practice scenarios
- trial informed consent exercises workshop
- adverse event understanding and documentation workshop
- case report form creation workshop
- clinical trial monitoring workshop
There are assessments associated with most of these workshops.

There will be an opportunity to tour a clinical trial facility to better understand how these principles are applied in practice.

Students will also have the option of either working in groups to create a clinical trial protocol in lieu of the final exam. Students will be given a research question, and will work in groups to design the clinical trial. The research question may be a drug being developed for a specific indication, a public health intervention or health services research.
Each student will submit a component of the final protocol for assessment, and a component of the assessment will also be for the overall protocol. This task suits students who prefer to work on problem solving tasks rather than focus on exam based assessment.

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 may will choose 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 practical clinical trial skills will be learnt. These will be supported by lectures (delivered by experts from industry).

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 in workshops and watching online lectures- 10%
Workshop related content ie online quizzes or workshop tasks - 40% overall between different workshops (approximately 10% each)
Midsemester exam - 20%
Final exam or group creation of protocol- 30%

Assessment Detail

Active participation in workshops- 10% (learning outcomes 1-7)
-Students will also be assessed for their active participation in the face to face or zoom lectures, workshops and the site visit. Students will be expected to actively engage in the workshops, in the small group discussions, and to participate in online or face to face lectures discussions ie ask and answer questions. Students who are unable to attend the lectures will be expected to have watched the lecture recordings for this assessment.

Workshop tasks - 40% (learning outcomes 1-6)
There will be a number of assessment tasks associated with the workshops which may be open book online assessment quiz or workshop task worth a total of 40%. The topics covered will include

Good Clinical Practice
Role of ethics and consent
Adverse events
Creating case report forms
Clinical trial monitoring

Midsemester exam- 20% (learning outcomes 1-5)
There will be a midsemester exam at the workshop time in week 8 which will cover the content in the first 6 weeks. This will be a open-book paper based exam and students are permitted to bring in paper-based resource material. No electronic sources will be allowed. The assessment will consist of MCQ and short answer questions. This assessment will make up 20% of the overall marks

Final assessment (30%)
Students have a choice of 2 different types of assessments: either a group based assignment to be handed in at the end of week 12, or an examination in the exam period. Students need to nominate which assessment they will choose at the beginning of the workshop in week 10.

1. Traditional exam (learning outcomes 1-7): There will be an end of year assessment consisting of multiple choice and short answer questions. This will be similarly a paper-based open book assessment where students will be able to bring in paper based resources. Students choosing this option do not need to attend the last 3 workshops.

2. Group assigment of protocol design (learning outcomes 1-7): the last 3 workshops of the course will consist of students working together in groups to design a clinical trial protocol based on a clinical research problem. Students will work collaboratively to design the overall study, and each student will submit an individual project covering one of the following areas of protocol design:
- study synopsis
- informed consent
- schedule of events
- study endpoints and sample size calculation
- inclusion and exclusion criteria
Students who work on the protocol creation task in the last 3 workshops do not have an end of year exam

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 <https://www.adelaide.edu.au/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 Access Adelaide.

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.
Student Support
Policies & Guidelines
This section contains links to relevant assessment-related policies and guidelines - all university policies.
Fraud Awareness

Students are reminded that in order to maintain the academic integrity of all programs and courses, the university has a zero-tolerance approach to students offering money or significant value goods or services to any staff member who is involved in their teaching or assessment. Students offering lecturers or tutors or professional staff anything more than a small token of appreciation is totally unacceptable, in any circumstances. Staff members are obliged to report all such incidents to their supervisor/manager, who will refer them for action under the university's student’s disciplinary procedures.

The University of Adelaide is committed to regular reviews of the courses and programs it offers to students. The University of Adelaide therefore reserves the right to discontinue or vary programs and courses without notice. Please read the important information contained in the disclaimer.

Authorised by:	Deputy Vice-Chancellor and Vice-President (Academic)
Maintained by:	Course Outlines Administrator