Students

PPCT8001 – Clinical Trial Operations

2024 – Session 1, Online-flexible

General Information

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Unit convenor and teaching staff Unit convenor and teaching staff Unit Convenor
Rania Salama
Contact via rania.salama@mq.edu.au
By appointment only (online or in-person consultations)
Credit points Credit points
10
Prerequisites Prerequisites
Corequisites Corequisites
PPCT8000
Co-badged status Co-badged status
Unit description Unit description

This specialised unit discusses the key operational aspects of designing, implementing, and monitoring a clinical trial and how they impact the trial success. You will learn about the various roles facilitating the participants' ethical and safe journey. You will appreciate the importance of accurately documenting trial source notes and delegations, and how they are reflected in the trial databases, provide a record for monitors and auditors, and ensure the trial conduct and results are built on credible principles and valid data. You will learn why adverse event management is pivotal to participants’ safety, how to classify and timely report adverse events. In addition, you will identify the practicalities of investigational product handling and tracking, safe handling of biological samples, as well as requirements of clinical trial equipment maintenance and calibration. This unit is co-designed with industry and offers pre-recorded industry expert lectures and interviews, real-world case studies, knowledge check quizzes and industry relevant assessments. You will achieve a Dangerous Goods Handling certificate upon successful completion of PPCT8001.

Important Academic Dates

Information about important academic dates including deadlines for withdrawing from units are available at https://www.mq.edu.au/study/calendar-of-dates

Learning Outcomes

On successful completion of this unit, you will be able to:

  • ULO1: Interpret components of key regulatory, ethical, trial governance and monitoring documents to ensure research integrity, validity, and participants welfare and confidentiality. (Capability 1 - Scientist and Scholar)
  • ULO2: Interpret medical notes, laboratory and scans reports and assess the need to escalate clinical and adverse events when necessary. (Capability 2 - Clinical Trial Practitioner)
  • ULO3: Demonstrate how to accurately document a clinical trial visit in source notes, data entry in electronic case reports and databases for archiving trial documents. (Capability 2 - Clinical Trial Practitioner)
  • ULO4: Evaluate the responsibilities and requirements for correct adverse events identification, classification and reporting in a clinical trial. (Capability 2 - Clinical Trial Practitioner)
  • ULO5: Evaluate the safety of handling of biological samples and dangerous goods, including compliance with international regulatory guidelines. (Capability 4 - Professional)
  • ULO6: Analyse clinical trial documentation to assess compliance of investigational product and biological sample handling, equipment maintenance and other trial aspects with study protocol, manuals and relevant regulations. (Capability 2 - Clinical Trial Practitioner)

General Assessment Information

Grade descriptors and other information concerning grading are contained in the Macquarie University Assessment Policy.

All final grades are determined by a grading committee, in accordance with the Macquarie University Assessment Policy, and are not the sole responsibility of the Unit Convenor.

Students will be awarded a final grade and a mark which must correspond to the grade descriptors specified in the Assessment Procedure (clause 128 and 129).

To pass this unit, you must demonstrate sufficient evidence of achievement of the learning outcomes, meet any ungraded requirements, and achieve a final mark of 50 or better. 

Further details for each assessment task will be available on iLearn.

Late Submissions

Unless a Special Consideration request has been submitted and approved, a 5% penalty (OF THE TOTAL POSSIBLE MARK) will be applied each day an assessment is not submitted, up until the 7th day (including weekends). After the 7th day, a grade of ‘0’ will be awarded even if the assessment is submitted. Submission time for all written assessments is set at 11.55pm. A 1-hour grace period is provided to students who experience a technical concern. 

 

For example:

Number of days (hours) late

Total Possible Marks

Deduction

Raw mark

Final mark

1 day (1-24 hours)

100

5

75

70

2 days (24-48 hours)

100

10

75

65

3 days (48-72 hours)

100

15

75

60

7 days (144-168 hours)

100

35

75

40

>7 days (>168 hours)

100

-

75

0

For any late submissions of time-sensitive tasks, such as scheduled tests/exams, performance assessments/presentations, and/or scheduled practical assessments/labs, students need to submit an application for Special Consideration.

Assessment Tasks

Name Weighting Hurdle Due
Study Documentation 45% No Check on iLearn site
Study Compliance Report 40% No Check on iLearn site
Dangerous Goods Shipping Quiz 0% Yes Check on iLearn site
Laboratory and Equipment Safety Report 15% No Check on iLearn site

Study Documentation

Assessment Type 1: Case study/analysis
Indicative Time on Task 2: 30 hours
Due: Check on iLearn site
Weighting: 45%

 

You will appropriately document study trial notes from a variety of sources and then enter this data into an electronic format.

 


On successful completion you will be able to:
  • Interpret components of key regulatory, ethical, trial governance and monitoring documents to ensure research integrity, validity, and participants welfare and confidentiality. (Capability 1 - Scientist and Scholar)
  • Interpret medical notes, laboratory and scans reports and assess the need to escalate clinical and adverse events when necessary. (Capability 2 - Clinical Trial Practitioner)
  • Demonstrate how to accurately document a clinical trial visit in source notes, data entry in electronic case reports and databases for archiving trial documents. (Capability 2 - Clinical Trial Practitioner)
  • Evaluate the responsibilities and requirements for correct adverse events identification, classification and reporting in a clinical trial. (Capability 2 - Clinical Trial Practitioner)

Study Compliance Report

Assessment Type 1: Report
Indicative Time on Task 2: 29 hours
Due: Check on iLearn site
Weighting: 40%

 

You will examine specific study site documentation and complete a monitoring visit report to ascertain the site is compliant with regulations and the study protocol.

 


On successful completion you will be able to:
  • Interpret components of key regulatory, ethical, trial governance and monitoring documents to ensure research integrity, validity, and participants welfare and confidentiality. (Capability 1 - Scientist and Scholar)
  • Interpret medical notes, laboratory and scans reports and assess the need to escalate clinical and adverse events when necessary. (Capability 2 - Clinical Trial Practitioner)
  • Demonstrate how to accurately document a clinical trial visit in source notes, data entry in electronic case reports and databases for archiving trial documents. (Capability 2 - Clinical Trial Practitioner)
  • Evaluate the responsibilities and requirements for correct adverse events identification, classification and reporting in a clinical trial. (Capability 2 - Clinical Trial Practitioner)
  • Analyse clinical trial documentation to assess compliance of investigational product and biological sample handling, equipment maintenance and other trial aspects with study protocol, manuals and relevant regulations. (Capability 2 - Clinical Trial Practitioner)

Dangerous Goods Shipping Quiz

Assessment Type 1: Quiz/Test
Indicative Time on Task 2: 5 hours
Due: Check on iLearn site
Weighting: 0%
This is a hurdle assessment task (see assessment policy for more information on hurdle assessment tasks)

 

You will complete an external Dangerous Goods training module and an online self-assessment quiz. You will upload your training completion certificate as a proof of fulfilment of this assessment task.

 


On successful completion you will be able to:
  • Evaluate the safety of handling of biological samples and dangerous goods, including compliance with international regulatory guidelines. (Capability 4 - Professional)

Laboratory and Equipment Safety Report

Assessment Type 1: Report
Indicative Time on Task 2: 6 hours
Due: Check on iLearn site
Weighting: 15%

 

You will demonstrate the effective application of relevant regulatory guidelines relating to laboratory handling and shipping of biological samples, dangerous goods and equipment maintenance.

 


On successful completion you will be able to:
  • Evaluate the safety of handling of biological samples and dangerous goods, including compliance with international regulatory guidelines. (Capability 4 - Professional)
  • Analyse clinical trial documentation to assess compliance of investigational product and biological sample handling, equipment maintenance and other trial aspects with study protocol, manuals and relevant regulations. (Capability 2 - Clinical Trial Practitioner)

1 If you need help with your assignment, please contact:

  • the academic teaching staff in your unit for guidance in understanding or completing this type of assessment
  • the Writing Centre for academic skills support.

2 Indicative time-on-task is an estimate of the time required for completion of the assessment task and is subject to individual variation

Delivery and Resources

PPCT8001Clinical Trial Operations is an online unit. As a student enrolled in this unit, you will engage in a range of online learning activities, including readings, videos, online modules, etc. Details can be found on the iLearn site for this unit.

Technology Used

Active participation in the learning activities throughout the unit will require students to have access to a tablet, laptop or similar device. 

Policies and Procedures

Macquarie University policies and procedures are accessible from Policy Central (https://policies.mq.edu.au). Students should be aware of the following policies in particular with regard to Learning and Teaching:

Students seeking more policy resources can visit Student Policies (https://students.mq.edu.au/support/study/policies). It is your one-stop-shop for the key policies you need to know about throughout your undergraduate student journey.

To find other policies relating to Teaching and Learning, visit Policy Central (https://policies.mq.edu.au) and use the search tool.

Student Code of Conduct

Macquarie University students have a responsibility to be familiar with the Student Code of Conduct: https://students.mq.edu.au/admin/other-resources/student-conduct

Results

Results published on platform other than eStudent, (eg. iLearn, Coursera etc.) or released directly by your Unit Convenor, are not confirmed as they are subject to final approval by the University. Once approved, final results will be sent to your student email address and will be made available in eStudent. For more information visit connect.mq.edu.au or if you are a Global MBA student contact globalmba.support@mq.edu.au

Academic Integrity

At Macquarie, we believe academic integrity – honesty, respect, trust, responsibility, fairness and courage – is at the core of learning, teaching and research. We recognise that meeting the expectations required to complete your assessments can be challenging. So, we offer you a range of resources and services to help you reach your potential, including free online writing and maths support, academic skills development and wellbeing consultations.

Student Support

Macquarie University provides a range of support services for students. For details, visit http://students.mq.edu.au/support/

The Writing Centre

The Writing Centre provides resources to develop your English language proficiency, academic writing, and communication skills.

The Library provides online and face to face support to help you find and use relevant information resources. 

Student Services and Support

Macquarie University offers a range of Student Support Services including:

Student Enquiries

Got a question? Ask us via the Service Connect Portal, or contact Service Connect.

IT Help

For help with University computer systems and technology, visit http://www.mq.edu.au/about_us/offices_and_units/information_technology/help/

When using the University's IT, you must adhere to the Acceptable Use of IT Resources Policy. The policy applies to all who connect to the MQ network including students.

Inclusion and Diversity

Social inclusion at Macquarie University is about giving everyone who has the potential to benefit from higher education the opportunity to study at university, participate in campus life and flourish in their chosen field. The University has made significant moves to promote an equitable, diverse and exciting campus community for the benefit of staff and students. It is your responsibility to contribute towards the development of an inclusive culture and practice in the areas of learning and teaching, research, and service orientation and delivery. As a member of the Macquarie University community, and when on external placement representing Macquarie University, you must not discriminate against or harass others based on their sex, gender, race, marital status, carers' responsibilities, disability, sexual orientation, age, political conviction or religious belief. All staff and students are expected to display appropriate behaviour that is conducive to a healthy learning environment for everyone including when on external placement activities. 

Professionalism

In the Faculty of Medicine, Health and Human Sciences, professionalism is a key capability embedded in all our courses.

As an adult learner, we respect your decision to choose how you engage with your learning, but we would remind you that the learning opportunities we create for you have been done so to enable your success, and that by not engaging you may impact your ability to successfully complete this unit. We equally expect that you show respect for the academic staff who have worked hard to develop meaningful activities and prioritise your learning. 

Another dimension of professionalism is having respect for your peers. It is the right of every student to learn in an environment that is free of disruption and distraction. Please communicate respectfully when interacting on discussion forums and in group assignments (when applicable). Please treat your fellow students with the utmost respect. If you are uncomfortable participating in any specific activity, please let the relevant academic know.


Unit information based on version 2024.02 of the Handbook