Delivery and Management of Clinical Trials

Delivery and Management of Clinical Trials

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

  • 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.

Module Overview

This module 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. It will explore the processes which must be implemented to monitor recruitment, data integrity and participant safety. The module will also focus on the regulatory requirements that must be adhered to for different types of ongoing trials, and strategies for the management of non-compliances and amendments to the project plan. 

Method of Teaching
The module involves a variety of teaching methods, including lectures, seminars, tutorials, practical classes/workshops and guided independent study. 

Learning Outcomes
By the end of the module you should be able to: 

  • 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.

Module Attendance Required
2 block week of teaching

Module Dates
2019/20

Spring term

Assessment

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

Academics involved in the delivery of this module
Clive Stubbs
Sarah Terne

Stand Alone Course 

Fee
£1028

Entry requirements

  • An interest in evidence-based practice
  • 2:1 honours degree (or equivalent) in a health or life sciences related subject (for example, medicine, pharmacy, nursing, psychology, health sciences), medical statistics or health economics
  • Individuals not meeting the above requirement who have equivalent relevant work experience will be considered on an individual basis.

To apply please contact the programme team at clinicaltrialsmsc@contacts.bham.ac.uk