Course Catalogue

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Personnel working in the clinical trial sector should have knowledge of and practical skills in managing the project accordingly. This course provides trial management skills, from participant recruitment through to trial closure.

This course runs for 6 weeks in Semester 2 and will be delivered face to face on campus.

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1. Group Presentation (20 minutes, 25%) [ILO1, ILO2].

2. Individual contribution to group performance (25%) [ILO1, ILO2].

3. Individual written assignment (1500-2000 words, 50%) [ILO3, ILO4].

Reassessments are normally available for all courses, except those which contribute to the Honours classification. Where, exceptionally, reassessment on Honours courses is required to satisfy professional/accreditation requirements, only the overall course grade achieved at the first attempt will contribute to the Honours classification. For non-Honours courses, students are offered reassessment in all or any of the components of assessment if the satisfactory (threshold) grade for the overall course is not achieved at the first attempt. This is normally grade D3 for undergraduate students and grade C3 for postgraduate students. Exceptionally it may not be possible to offer reassessment of some coursework items, in which case the mark achieved at the first attempt will be counted towards the final course grade. Any such exceptions for this course are described below. 

Elements of groupwork are not re-assessable.

The specific aims of this taught course are:

■ To provide students with knowledge on trial monitoring and, the process for reporting issues and amendments.

■ To provide knowledge of the role of audits and inspections in ensuring compliance with good clinical practice.

■ To provide training and knowledge on how to close trials centrally and at each active site, and the potential implications of trials being terminated prematurely (including misconduct).

■ To familiarise students with the considerations around general data protection regulation and trial misconduct.

■ To familiarise students with the reporting procedures to all stakeholders.

By the end of this course students will be able to:

1. Design management elements, such as planning, coordination, regulatory compliance, team leadership, quality assurance, budget and resource management, data management and reporting, risk management, patient safety and documentation in clinical trials.

2. Critically evaluate project plans for clinical trials, including scope, timelines, budgets, and risk management strategies.

3. Identify regulatory and ethical standards relevant to the management of clinical trials.

4. Examine quality assurance and quality control processes to ensure the integrity and reliability of clinical trial data.

Students must submit at least 75% by weight of the components (including examinations) of the course's summative assessment.