Delivery and Management of Clinical Trials20 credits

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. It will explore the processes which must be implemented to monitor recruitment, data integrity and participant safety. The course 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.

Academics involved in the delivery of this course

• Dr Adam Devall - Associate Professor of Maternal Health Clinical Trials Tommy's National Centre for Miscarriage Research and WHO Collaborating Centre for Global Women’s Health
• Razia Meer-Baloch - Lecturer in Clinical Trials - Training Education and Strategy Lead for Clinical Trials
• Clive Stubbs

Method of Teaching

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

Content

On completion, 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.

Attendance Required

2 block week of teaching.

Course dates

20 - 24 January
3 - 7 February
17 - 21 March 2025

Assessment

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

Credits

20 credits

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.

For further information, please contact the programme team at clinicaltrialsmsc@contacts.bham.ac.uk

Why choose a Postgraduate Microcredential short course?

• Microcredentials offer the perfect opportunity to boost your CV without the commitment of a full degree
• Usually taken from existing modules within a Masters, they can be used as standalone credentials with some also counting as academic credits at postgraduate level
• Add a postgraduate level qualification to your CV
• Develop the specialist skills you need for your career goals
• Alumni status with the University of Birmingham
• Learners will have the same access to our student support and campus facilities as our students on full degree programmes.

Please note the deadline for submitting an application:

• Applicants eligible for Home fees are to apply a minimum of 6 weeks before the module start date.
• Applicants eligible for Overseas fees are to apply a minimum of 3 months before the module start date.

Please note that once registered for the microcredential you cannot swap for the non-credit short course version.

Non-credit short course

The microcredential and the non-credit short course follow the same course structure, the difference between them both is with the non-credit short course you do not take the assessment at the end therefore you will not receive credits but will receive a certificate of completion, this certificate cannot be converted to credits.

Please note if you apply for the non-credit short course, you cannot swap to the microcredential version once registered.

Places on the non-credit shortcourse are limited so please enquire before if spaces are available.