Preparation and Set-up for a Clinical Trial20 credits

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

• Rationale for Clinical Trials, Key Concepts and Features
• Delivery and Management of Clinical Trials

It can also be taken on a stand-alone basis.

This course aims to provide students with an understanding of the procedural and logistical considerations when setting up a trial. It will identify the roles and responsibilities of key players and will describe the processes to be conducted to ensure compliance with research governance and Good Clinical Practice (GCP). Students will be exposed to current issues in the set-up of trials, and will explore, through real world examples, effective solutions and approaches to trial set-up. The module will include lectures, facilitated discussion and student presentation, and workshops will be incorporated through which students will develop the skills key to successful and efficient planning.

Academics involved in the delivery of this course

Miss Sarah Pirrie - Principal Biostatistician - Cancer Research UK Clinical Trials Unit (CRCTU)

Dr Joshua Savage- Early Drug Development Trial Management Team Leader at the Cancer Research UK Clinical Trials Unit (CRCTU)

By the end of the course you should be able to:

• Defend the requirement for a multidisciplinary, collaborative approach to developing and setting-up a trial.
• Construct plans detailing the resource requirements for a trial, and allocate costs in compliance with established funding frameworks.
• Develop trial plans, including risk assessment and mitigation; and implement systems required to operationalize and effectively manage recruitment, data and participant safety.
• Examine the roles and responsibilities of those involved in the delivery of a trial, and plan appropriate oversight.
• Summarise the ethical and regulatory approval process for different types of trials in the UK.
• Design essential trial documents needed for the efficient running of a trial, with consideration of different trial types and different trial participants.
• Recognise the key considerations in identifying sites and site investigators for a trial and outline the preparatory steps needed prior to site initiation.

Attendance required

2 block week of teaching

Course dates

11-15 and 25-29 November

Assessment

1. A 1.5 hour unseen examination (40%)
2. Development of 3 pieces of clinical trial documentation (60%)

Credits

20 credits

• 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.

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 short course are limited so please enquire before if spaces are available.