BIM303 Clinical Trials Management

What is this course about?

Description

Clinical trials are research studies in humans that evaluate the effect of a behavioral, medical or surgical intervention. This course introduces you to the principles of clinical research, including Good Clinical Practice (GCP), as well as preclinical drug development, regulatory affairs, and human research ethics. As part of this course, you will complete an internationally recognized accredited GCP certificate, which is a requirement for any professional working in clinical trials.

How will this course be delivered?

Course Topics

Am I eligible to enrol in this course?

Refer to the UniSC Glossary of terms for definitions of “pre-requisites, co-requisites and anti-requisites”.

Pre-requisites

BIM263 Introduction to Pharmacology or BIM341 Biochemical Pharmacology.

Co-requisites

Not applicable

Anti-requisites

Not applicable

Specific assumed prior knowledge and skills (where applicable)

It is recommended that students have some prerequisite knowledge of pharmacology, research methods and basic statistics.

How am I going to be assessed?

Grading Scale

Standard Grading (GRD)

Details of early feedback on progress

Students will have a revision session prior to the Review Quiz (Task 1), which will be based on theory covered during Workshops 1 to 6. Also, students may seek guidance from the course coordinator on the structure and content of their Human Research Ethics Assignment (Task 2a). 

Assessment tasks

2-hour duration.

Varied throughout session

2-hour duration.

Directed study hours

A 12-unit course will have total of 150 learning hours which will include directed study hours (including online if required), self-directed learning and completion of assessable tasks. Student workload is calculated at 12.5 learning hours per one unit.

Schedule

Topic 1

Drug discovery, preclinical development and medical device development

Topic 2

Clinical research studies

Topic 3

Human research ethics and governance in clinical trials

Topic 4

Roles and responsibilities of clinical trial stakeholders

Topic 5

Clinical trial phases and participant eligibility

Topic 6

Patient communication and the informed consent process

Topic 7

Consumer involvement and engagement in clinical trials

Topic 8

Documentation and data collection during clinical trials

Topic 9

Auditing and monitoring in clinical trials

Topic 10

Clinical trial safety: monitoring and reporting

Topic 11

Regulation and pharmacovigilance

Topic 12

Clinical trials: special circumstances and what the future may hold

Topic 13

Principles of Good Clinical Practice (GCP)

What resources do I need to undertake this course?

Please note: Course information, including specific information of recommended readings, learning activities, resources, weekly readings, etc. are available on the course Canvas site– Please log in as soon as possible.

Prescribed text(s) or course reader

There are no required/recommended resources for this course.

Specific requirements

There are no prescribed textbooks for the BIM303 course.  You will be provided access to an online training module offered by Praxis Australia via the BIM303 Canvas site.  In addition, you will be referred to government websites that contain important documents that outline guidelines and information associated with monitoring and managing clinical trials in Australia.  There also will be readings that you will need to download from the BIM303 Canvas site for the tutorial classes.

What administrative information is relevant to this course?

Assessment: Academic Integrity

Academic integrity is the ethical standard of university participation.  It ensures that students graduate as a result of proving they are competent in their discipline.  This is integral in maintaining the value of academic qualifications. Each industry has expectations and standards of the skills and knowledge within that discipline and these are reflected in assessment.

Academic integrity means that you do not engage in any activity that is considered to be academic fraud; including plagiarism, collusion or outsourcing any part of any assessment item to any other person.  You are expected to be honest and ethical by completing all work yourself and indicating in your work which ideas and information were developed by you and which were taken from others. You cannot provide your assessment work to others. You are also expected to provide evidence of wide and critical reading, usually by using appropriate academic references.

In order to minimise incidents of academic fraud, this course may require that some of its assessment tasks, when submitted to Canvas, are electronically checked through Turnitin.  This software allows for text comparisons to be made between your submitted assessment item and all other work to which Turnitin has access.

Assessment: Additional Requirements

Eligibility for Supplementary Assessment

Your eligibility for supplementary assessment in a course is dependent of the following conditions applying:
(a) The final mark is in the percentage range 47% to 49.4%; and
(b) The course is graded using the Standard Grading scale

Assessment: Submission penalties

Late submissions may be penalised up to and including the following maximum percentage of the assessment task’s identified value, with weekdays and weekends included in the calculation of days late:
(a) One day: deduct 5%;
(b) Two days: deduct 10%;
(c) Three days: deduct 20%;
(d) Four days: deduct 40%;
(e) Five days: deduct 60%;
(f) Six days: deduct 80%;
(g) Seven days: A result of zero is awarded for the assessment task.
The following penalties will apply for a late submission for an online examination:
Less than 15 minutes: No penalty
From 15 minutes to 30 minutes: 20% penalty
More than 30 minutes: 100% penalty

SafeUniSC

UniSC is committed to a culture of respect and providing a safe and supportive environment for all members of our community. For immediate assistance on campus contact SafeUniSC by phone: 07 5430 1168 or using the SafeZone app. For general enquires contact the SafeUniSC team by phone 07 5456 3864 or email safe@usc.edu.au.

The SafeUniSC Specialist Service is a Student Wellbeing service that provides free and confidential support to students who may have experienced or observed behaviour that could cause fear, offence or trauma. To contact the service call 07 5430 1226 or email studentwellbeing@usc.edu.au.

Study help

For help with course-specific advice, for example what information to include in your assessment, you should first contact your tutor, then your course coordinator, if needed.

If you require additional assistance, the Learning Advisers are trained professionals who are ready to help you develop a wide range of academic skills. Visit the Learning Advisers web page for more information, or contact Student Central for further assistance: +61 7 5430 2890 or studentcentral@usc.edu.au.

Wellbeing Services

Student Wellbeing provide free and confidential counselling on a wide range of personal, academic, social and psychological matters, to foster positive mental health and wellbeing for your academic success.

To book a confidential appointment go to Student Hub, email studentwellbeing@usc.edu.au or call 07 5430 1226.

AccessAbility Services

Ability Advisers ensure equal access to all aspects of university life. If your studies are affected by a disability, learning disorder mental health issue, injury or illness, or you are a primary carer for someone with a disability or who is considered frail and aged, AccessAbility Services can provide access to appropriate reasonable adjustments and practical advice about the support and facilities available to you throughout the University.

To book a confidential appointment go to Student Hub, email AccessAbility@usc.edu.au or call 07 5430 2890.

Links to relevant University policy and procedures

For more information on Academic Learning & Teaching categories including:

• Assessment: Courses and Coursework Programs
• Review of Assessment and Final Grades
• Supplementary Assessment
• Central Examinations
• Deferred Examinations
• Student Conduct
• Students with a Disability

For more information, visit https://www.usc.edu.au/explore/policies-and-procedures#academic-learning-and-teaching

Student Charter

UniSC is committed to excellence in teaching, research and engagement in an environment that is inclusive, inspiring, safe and respectful. The Student Charter sets out what students can expect from the University, and what in turn is expected of students, to achieve these outcomes.

General Enquiries

• In person:
  • UniSC Sunshine Coast - Student Central, Ground Floor, Building C, 90 Sippy Downs Drive, Sippy Downs
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• Tel:+61 7 5430 2890
• Email:studentcentral@usc.edu.au