Module and Programme Catalogue

Search site

Find information on

2019/20 Taught Postgraduate Module Catalogue

MEDR5180M Clinical Trials Research

15 creditsClass Size: 30

Module manager: Maria Bryant
Email: m.j.bryant@leeds.ac.uk

Taught: Semester 1 (Sep to Jan) View Timetable

Year running 2019/20

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 not 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 all aspects of a clinical research trial;
- lead a small clinical research trial grant application;
- contribute to a larger clinical research trial grant application;
- learn and experience writing standard operating procedures;
- describe how to disseminate results from a clinical research trial;
- 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.

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. In a series of seminars with group activities, 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 research trial and dissemination of clinical research trial results. Emphasis will be placed on practical aspects of running a clinical research trial.

A problem-based approach to learning will be used to lead students towards a knowledge and understanding of these aspects of clinical research trials. Students will attend a variety of lectures, seminars and group work sessions.

Teaching methods

Delivery typeNumberLength hoursStudent hours
Seminar162.0032.00
Private study hours118.00
Total Contact hours32.00
Total hours (100hr per 10 credits)150.00

Private study

Students will be introduced to research phases and asked to think critically about whether existing studies were designed appropriately according to the research objectives. They will be divided into groups (3-4) and each group will be given an anonymous manuscript. It will be their task to determine which phase of research the manuscript is attempting to discuss. In addition, another manuscript will be provided to each group and will be tasked with critically evaluating it to determine the appropriateness of the study design phase. This work will be introduced in the teaching session, and groups will be given time to start work during the session. However, they are expected to work independently outside the session to produce a 5 minute presentation of their results. This piece of work will contribute towards 10% of their assessment.

Students will be introduced to the idea of using standard operating procedures to improve efficiency and manageability of clinical research trials and will be asked to write one from a choice of 3 topics. In order to do this, they will be presented with an anonymous methods section of a grant application. This piece of coursework will count towards 20% of their final assessment and will be given to students approximately half way through the course to be completed in their own time by the end of the course.

Opportunities for Formative Feedback

Formative assessment will involve monitoring students’ progress through discussion both following lectures/seminars and during the group activities. In addition students produce a short presentation of their groups critical appraisal of an existing study/existing studies.

Methods of assessment


Coursework
Assessment typeNotes% of formal assessment
Written WorkShort summary of a grant application70.00
ProjectWriting a SOP (Standard Operating Proceedure)20.00
Group ProjectCritical review and presentation10.00
Computer ExerciseGCP if applicable0.00
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: 22/05/2019

Disclaimer

Browse Other Catalogues

Errors, omissions, failed links etc should be notified to the Catalogue Team.PROD

© Copyright Leeds 2019