Program Overview

This short course on project management of clinical trials equips students with essential knowledge and skills, encompassing risk mitigation, site initiation planning, ongoing trial management, and data validation. It aligns with the MSc/PGDip Clinical Trials program and can be taken as a standalone course, blending diverse teaching methods with hands-on activities. The assessment includes an oral presentation (40%) and an extended writing (60%).

Program Outline

Degree Overview:

This is a short course on the MSc/PGDip Clinical Trials programme. It is available as an optional course on the PGCert when taken alongside the following:

• Rationale for Clinical Trials, Key Concepts and Features
• Preparation and Set-up for a Clinical Trial
It can also be taken on a stand-alone basis. This short course will provide students with an in-depth understanding of the fundamentals of the project management of trials and the impact of effective and efficient communication with all key players.

Outline:

• Content:
• Determine the factors that may contribute to the success or failure of a trial project plan and devise a plan which has the flexibility to successfully adapt to change.
• Evaluate the ongoing risks associated with different types of trial and propose risk adaptive techniques to mitigate such risks.
• Plan and deliver a site initiation visit to a multidisciplinary group, with consideration of potential barriers to effective communication.
• Describe the considerations for the ongoing management of open trials and how specific threats to a trial’s successful completion can be minimised.
• Implement appropriate amendments to the project plan in response to unexpected events in compliance with project timelines and regulatory requirements.
• Develop and appraise a plan for the management and validation of trial data.
• Structure:
• 2 block week of teaching.
• Dates: 15 - 19 January and 29 January – 2 February 2024.
• Modules:
It can also be taken on a stand-alone basis.

Assessment:

• Oral presentation (40%).
• A 2,500-word extended writing (60%).

Teaching:

• The short course involves a variety of teaching methods, including lectures, seminars, tutorials, practical classes/workshops and guided independent study.

Other:

• Prerequisites: Pre-existing knowledge required: completion of Preparation & set-up of clinical trials module or have accessed pre-recorded material OR have experience working within the preparation and set up of trials.
• Coordinators: Adam Devall, Razia Meer-Baloch, Clive Stubbs