Preparation and Set-up for a Clinical Trial
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.
Overview
This module 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.
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:
- 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
Assessment
- A 1.5 hour unseen examination (40%)
- Development of 3 pieces of clinical trial documentation (60%)
Academics involved in the delivery of this module
Miss Sarah Pirrie
Dr Joshua Savage
Stand Alone Course
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 or for further information, please contact the programme team at clinicaltrialsmsc@contacts.bham.ac.uk