2021/22 Taught Postgraduate Module Catalogue

MEDR5180M Clinical Trials Research

15 creditsClass Size: 30

Module manager: Sue Bell, Michelle Collinson
Email: s.e.bell@leeds.ac.uk, m.collinson@leeds.ac.uk

Taught: Semester 1 (Sep to Jan) View Timetable

Year running 2021/22

Pre-requisite qualifications

Normally, a degree in medicine, dentistry, nursing, health care, health management, a science, a social science or a profession allied to medicine.

Applications are encouraged from non-graduates with work experience in health research.

Normally attendance at Modules:
MEDR3010 (Introducing research),
MEDR5100 (Capturing data for research)
MEDR510M (Handling data in research)
MEDR3020 (Writing and disseminating research)
MEDR5120M (Analytic research)
MEDR5130M (Intervention research).

This module is approved as an Elective

Module summary

1. Clinical Trials Research Unit structure2. Introduction to funding bodies and grant applications3. Phases of Clinical Trials research4. Good clinical practice5. Running a clinical trial:> a. grant applications> b. setting up a trial> c. data collection6. Dissemination and clinical applications

Objectives

On completion of this module, students should be able to:

- describe the structure of a clinical trials research unit and how it operates;
- differentiate between different research designs and associated objectives for different phases of research;
- describe the impact of ethics on aspects of a clinical trial;
- lead a small clinical trial research grant application;
- contribute to a larger clinical trial research grant application;
- write a standard operating procedures;
- describe how to disseminate results from a clinical trial;
- set up and run a small clinical trial;
- take responsibility for the day-to-day running of a sub-section of a large clinical trial.

Learning outcomes
On completion of this module students should be able to:

- describe how a clinical trials research unit operates;
- define and describe different designs and associated objectives for the different phases of clinical trials research;
- explain how ethics impacts on all aspects of a clinical research trial;
- write a small clinical research trial grant application;
- contribute to a larger clinical research trial grant application;
- describe how to disseminate clinical research trial results;
- describe how to run a clinical research trial, including set up and writing standard operating procedures.

Skills outcomes
On completion of this module students should have the ability to:

- describe the role of a clinical trials research unit;
- define different designs and associated objectives for the phases of research trials;
- explain how ethics impacts on all aspects of clinical trials research;
- write a small clinical research trial grant application;
- contribute to a larger clinical research trial grant application;
- describe how to disseminate clinical trial research results;
- describe how to run a clinical research trial, including writing standard operating procedures and adherence to good clinical practice;
- set up and run a small clinical research trial;
- take responsibility for the day-to-day running of a sub-section of a large clinical research trial.

Syllabus

The teaching style for this module will be active and participative. Where the module is taught entirely online we will replicate ‘group activities’ and students will be asked to complete online tasks and activities that mirror the pre-Covid19 teaching style. Students will be introduced to the structure of a clinical trials research unit, funding bodies and grant applications for clinical trials research, phases of clinical trials research, good clinical practice, running a clinical trial and dissemination of clinical trial results. Emphasis will be placed on practical aspects of running a clinical trial.

Students will gain knowledge and understanding of these aspects of clinical trials. Students will engage with variety of lectures, seminars and activity based sessions.

Teaching methods

Delivery type	Number	Length hours	Student hours
Seminar	16	2.00	32.00
Private study hours			118.00
Total Contact hours			32.00
Total hours (100hr per 10 credits)			150.00

Private study

Independent online learning will supplement the formal classes and will make use of a portfolio of materials. Students will also be expected to work in their own time, researching taught and online course work, building up their knowledge using the guidance provided by formal taught and online components of the module.

Opportunities for Formative Feedback

Formative assessment will involve monitoring students’ progress through discussion both following lectures/seminars and during the group activities. Students will complete a quiz in class (or online equivalent) and receive formative feedback on their responses (online feedback will be automated). Where the module is taught entirely online this discussion, feedback and reflection will mirror the pre-Covid19 opportunities, taking the form of teleconference drop-in surgeries during the module.

Methods of assessment

Coursework

Assessment type	Notes	% of formal assessment
Written Work	Short summary of a grant application	75.00
Project	Writing a SOP (Standard Operating Proceedure)	25.00
Total percentage (Assessment Coursework)		100.00

Normally resits will be assessed by the same methodology as the first attempt, unless otherwise stated

Reading list

There is no reading list for this module

Last updated: 30/06/2021 16:22:53

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