Please note: there may be some adjustments to the teaching arrangements published in the course catalogue for 2020-21. Given current circumstances related to the Covid-19 pandemic it is anticipated that some usual arrangements for teaching on campus will be modified to ensure the safety and wellbeing of students and staff on campus; further adjustments may also be necessary, or beneficial, during the course of the academic year as national requirements relating to management of the pandemic are revised.

Clinical Trials : Principles and Methods MED5336

  • Academic Session: 2021-22
  • School: School of Cardiovascular and Metabolic
  • Credits: 20
  • Level: Level 5 (SCQF level 11)
  • Typically Offered: Semester 2
  • Available to Visiting Students: No
  • Available to Erasmus Students: No

Short Description

The course will provide students with a working knowledge of the principles and methods involved in Clinical Trials.

Timetable

This course will be taught in 4/5 hour blocks for a total of 20 hours, these blocks may be taught consecutively over the course of 5 days.

Requirements of Entry

none

Excluded Courses

none

Co-requisites

none

Assessment

Assessment

Assignment in the form of a design for a Clinical Trial (2000 words) worth 40% of final grade

Written examination worth 60% of final grade

Main Assessment In: April/May

Course Aims

This course aims to provide students with the opportunity to develop their confidence and skill to apply the basic principles and methods required for conducting Clinical Trials

Intended Learning Outcomes of Course

By the end of this course students will be able to:

■ Critically appraise the legal, ethical and regulatory issues underlying clinical trials

■ Critically discuss, evaluate and apply the appropriate theories, principles and methods required to construct a study design

■ Critically compare and select methods of randomisation, data collection and database management

■ Critically compare and select methods recruitment and retention

■ Critically appraise recognised methods of safety reporting and monitoring

■ Critically discuss and evaluate appropriate methods for study closedown

■ Critically compare, contrast and select appropriate methods of analysis and interpretation of trial results

■ Critically evaluate trial results and put them in to context, using judgement and supporting conclusions

Minimum Requirement for Award of Credits

Students must submit at least 75% by weight of the components (including examinations) of the course's summative assessment.