HLTH SC 3101 - Clinical Trials Management: Principles and Practice

North Terrace Campus - Semester 2 - 2019

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 Studies
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
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. Design a clinical trial synopsis to answer a research question
2. Work in a group to create a clinical trial protocol de novo or from a trial synopsis
3. Be able to critically evaluate a clinical trial synopsis, protocol, and patient information sheet
4. Understand the regulatory and reporting requirements for clinical trials
5. Have an understanding of the principles of Good Clinical Practice
6. Create a patient information sheet from 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)
Deep discipline knowledge informed and infused by cutting edge research, scaffolded throughout their program of studies acquired from personal interaction with research active educators, from year 1 accredited or validated against national or international standards (for relevant programs)	1-6
Critical thinking and problem solving steeped in research methods and rigor based on empirical evidence and the scientific approach to knowledge development demonstrated through appropriate and relevant assessment	1-3
Teamwork and communication skills developed from, with, and via the SGDE honed through assessment and practice throughout the program of studies encouraged and valued in all aspects of learning	2,6
Career and leadership readiness technology savvy professional and, where relevant, fully accredited forward thinking and well informed tested and validated by work based experiences	1-6
Self-awareness and emotional intelligence a capacity for self-reflection and a willingness to engage in self-appraisal open to objective and constructive feedback from supervisors and peers able to negotiate difficult social situations, defuse conflict and engage positively in purposeful debate	2

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, 2007

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

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 3 tutorials for small group discovery of specific topics to support the lectures.
There are 6 workshops in small group discovery experiences where students will work together to discus and will develop clinical trial protocols based on information provided to them on two hypothetical drugs.

Workload

No information currently available.

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.

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

The assessment for this course will be as follows:
Mid-semester exam 20%
Individual assignment (just one) of 15%
Online quizzes of 10%
Group study management plan and presentations 25%
Final exam 30%

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 2 assignments submitted and each 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

No information currently available.

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