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 pre-clinical 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.

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

Assessment tasks

Varied throughout session

1-hour duration; multi-choice questions. Total 50 marks.

2-hour duration; multiple-choice and short answer questions. Total 100 marks.

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

Drug discovery and preclinical development.

An overview of the drug development process.
Key stakeholders in drug development.
History of drug discovery.
Target identification.
Finding and optimising lead compounds.
Preclinical (nonclinical) development.
Pharmacological testing.
The Investigator's Brochure.

Overview of the clinical trial process.

Overview of the clinical trial process.
Phases I, II, III and IV clinical trials.
Research design for clinical trials.

Human research ethics in clinical trials.

What is human research ethics and why is it needed in clinical trials?
Fundamental principles in human ethics underpinning the National Statement.
Gaining ethics approval for human research.
Roles of the Human Research Ethics Committee.
Case studies in human research ethics.

Patient communication and informed consent.

Effective and compassionate patient communication
What is informed consent and why is it needed in clinical trials?
Obtaining informed consent
Limited disclosure
Importance of confidentiality

Data collection during clinical trials.

Importance of accurate data collection
Data collection tools
Source data verification

Principles of Good Clinical Practice (GCP)

Define Good Clinical Practice 
Laws and guidelines that govern the conduct of clinical research
Roles and responsibilities of stakeholders involved in clinical research

Regulation of drugs and devices

Need for regulation of drugs and medical devices.
Regulatory framework for drugs and medical devices in Australia.
Funding of medicines and medical devices in Australia
Events in the later phases of the medicines lifecycle

Essential documentation in clinical trials

Essential Documents
Source Documentation
Storage requirements for different documents in clinical trials.
Safety form types, completion and maintenance 
Safety reporting responsibilities

Research monitoring and audit

Monitoring a clinical trial, including the key stages
Risk Based Monitoring 
Auditing a clinical trial

Safety monitoring and reporting

Adverse event 
Adverse incident
Information included in a safety report
Expedited reporting based on seriousness, causality and expectedness

Principles of research governance

Ethical principles and guidelines for the responsible conduct of research in Australia.
Elements of research governance. What needs to be considered by Australian institutions when governing research conducted under their auspices?
What is site-specific assessment?
Establishing a clinical trial agreement.
The importance of insurance and indemnity in clinical trials.

Role and responsibilities of clinical trial stakeholders, including the clinical trial coordinator (CRC) and pharmacy.

Specific responsibilities of the CRC in relation to study set-up and conduct of the study.
Importance of Good Clinical Practice (GCP) for the CRC.
Scheduling challenges faced by CRCs.
Role of CRCs in overseeing quality assurance and safety in clinical trials, including minimising risk on treatment days.
General role of the pharmacist in clinical trials.
Pre-study activities of the pharmacist.
Shipment and receipt of the Investigational Medicinal Product (IMP).
Dispensing and accountability.
Monitoring and study conclusion responsibilities.

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 the online training modules 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

Your eligibility for supplementary assessment in a course is dependent of the following conditions applying:
- The final mark is in the percentage range 47% to 49.4%.
- The course is graded using the Standard Grading scale.
- You have not failed an assessment task in the course due to academic misconduct.

Assessment: Submission penalties

Late submission of assessment tasks may be penalised at the following maximum rate (the rates are cumulative): 
- 5% (of the assessment task's identified value) per day for the first two days from the date identified as the due date for the assessment task. 
- 10% (of the assessment task's identified value) for the third day 
- 20% (of the assessment task's identified value) for the fourth day and subsequent days up to and including seven days from the date identified as the due date for the assessment task. 
- A result of zero is awarded for an assessment task submitted after seven days from the date identified as the due date for the assessment task. 
Weekdays and weekends are included in the calculation of days late. 
To request an extension you must contact your course coordinator to negotiate an outcome.

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

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