LBIOL62121A Clinical Trials Research Project Course Descriptor

Course Overview

In this course, learners will undergo a hypothesis-driven work-based project linked to the conduct of clinical trials and this must be undergone by the learner as part of their routine work-place activity. Learners will undertake critical analysis of the literature and develop and implement a robust procedure of scientific inquiry of how to address gaps in one area of the lifecycle of clinical trials. Data collection, filtering and analysis and considerations about Good Clinical Practice will be a key focus of the project, using appropriate analytical, statistical and data visualisation methods to draw robust and balanced conclusions. The project is assessed through a dissertation and viva voce exam. Typical project examples include comparing monotherapies with combined therapies, reducing bias in participants selection and recruitment, investigating the pros and cons of different trial settings (for example, fully decentralised clinical trials versus hybrid), risk-based management.

Learning Outcomes

On successful completion of the course, learners will be able to:

Knowledge and Understanding

Subject Specific Skills

Transferable and Professional Skills

Teaching and Learning

This is an e-learning course, taught throughout the year. 

This course can be offered as a standalone short course.

Teaching and learning strategies for this course will include: 

• Online learning
• Online discussion groups
• Online assessment

Course information and supplementary materials will be available on the University’s Virtual Learning Environment (VLE).

Learners are required to attend and participate in all the formal and timetabled sessions for this course. Learners are also expected to manage their self-directed learning and independent study in support of the course.

The course learning and teaching hours will be structured as follows:

• Off-the-job learning (18 days x 7 hours) = 126 hours (e.g. 1 day per week for 18 weeks)
• On-the-job learning (54 days x 7 hours) = 378 hours (e.g. 3 days per week for 18 weeks)
• Private study (5.33 hours per week for 18 weeks) = 96 hours
• Total 600 hours

Assessment

Formative

Students will be formatively assessed during the course by means of set assignments. These will not count towards the final degree but will provide students with developmental feedback.

Summative

Feedback

Learners will receive formal feedback in a variety of ways: written (via email or VLE correspondence) and indirectly through online discussion groups. Learners will also attend a formal meeting with their Academic Advisor or Success Manager (and for apprentices, including their Line Manager). These bi or tri-partite reviews will monitor and evaluate the learner’s progress.  

Feedback is provided on summatively assessed assignments and through generic internal examiners’ reports, both of which are posted on the VLE.

Indicative Reading

Note: Comprehensive and current reading lists for courses are produced annually in the Course Guide or other documentation provided to learners; the indicative reading list provided below is used as part of the approval/modification process only.

Books

Stephan F. M., and Smith, I., 2019. A Practical Guide to Dissertation and Thesis Writing. Newcastle upon Tyne, England : Cambridge Scholars Publishing 

The references from a number of the other modules will be useful in completing the project. It is expected that research journals and other publications will also be used to support the project.

Journals

Learners are encouraged to read material from relevant journals as directed by their course leader.

Electronic Resources

Learners are encouraged to consult relevant websites on the history and general design of clinical trials.

Indicative Topics

Students will study the following topics:

• Clinical Trials Research
• Hypothesis-driven project
• Analysis, reporting and recommendations to improve processes.

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