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MT5921: CLINICAL TRIALS: REGULATION, GOVERNANCE AND SAFETY (2020-2021)

Last modified: 05 Aug 2021 13:04


Course Overview

The course will provide an understanding of the role of governance and regulatory requirements for clinical research and will be invaluable to researchers whether scientists or medics.

Course Details

Study Type Postgraduate Level 5
Session Third Sub Session Credit Points 15 credits (7.5 ECTS credits)
Campus Aberdeen Sustained Study No
Co-ordinators
  • Professor Helen Galley

What courses & programmes must have been taken before this course?

  • Any Postgraduate Programme (Studied)

What other courses must be taken with this course?

None.

Are there a limited number of places available?

No

Course Description

The course will comprise lectures, group discussion and seminars and focuses on clinical trial design and conduct plus research governance including ethics, pharmacovigilance and safety. Importantly, there will be emphasis on using skills, knowledge and understanding to communicate information to a variety of different audiences which is a key requirement in clinical research.


In light of Covid-19 this information is indicative and may be subject to change.

Contact Teaching Time

Information on contact teaching time is available from the course guide.

Teaching Breakdown

  • 1 Tutorial during University weeks 40 - 47

More Information about Week Numbers


In light of Covid-19 and the move to blended learning delivery the assessment information advertised for second half-session courses may be subject to change. All updates for second-half session courses will be actioned in advance of the second half-session teaching starting. Please check back regularly for updates.

Summative Assessments

Infographic

Assessment Type Summative Weighting 15
Assessment Weeks 33 Feedback Weeks

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Feedback

Infographic (small groups) to provide trial information to a general audience.

Learning Outcomes
Knowledge LevelThinking SkillOutcome
Sorry, we don't have this information available just now. Please check the course guide on MyAberdeen or with the Course Coordinator

Oral Presentation: Individual

Assessment Type Summative Weighting 25
Assessment Weeks 31 Feedback Weeks

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Feedback

10 min presentation.

Learning Outcomes
Knowledge LevelThinking SkillOutcome
Sorry, we don't have this information available just now. Please check the course guide on MyAberdeen or with the Course Coordinator

Participant information sheet

Assessment Type Summative Weighting 25
Assessment Weeks 35 Feedback Weeks

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Feedback

Summary written for a trial participant.

Learning Outcomes
Knowledge LevelThinking SkillOutcome
Sorry, we don't have this information available just now. Please check the course guide on MyAberdeen or with the Course Coordinator

Essay

Assessment Type Summative Weighting 35
Assessment Weeks 28 Feedback Weeks

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Feedback Word Count 2000
Learning Outcomes
Knowledge LevelThinking SkillOutcome
Sorry, we don't have this information available just now. Please check the course guide on MyAberdeen or with the Course Coordinator

Formative Assessment

There are no assessments for this course.

Resit Assessments

Essay

Assessment Type Summative Weighting
Assessment Weeks Feedback Weeks

Look up Week Numbers

Feedback Word Count
Learning Outcomes
Knowledge LevelThinking SkillOutcome
Sorry, we don't have this information available just now. Please check the course guide on MyAberdeen or with the Course Coordinator

Course Learning Outcomes

Knowledge LevelThinking SkillOutcome
FactualUnderstandStudents will be able to demonstrate a critical understanding of the principles of governance for clinical trials
ConceptualCreateStudents will be able to use their knowledge, skills and understanding to plan, create and deliver information in a professional context
FactualAnalyseStudents will be able to integrate their knowledge and understanding to communicate, using appropriate methods, to a range of audiences with different levels of knowledge/expertise.
ProceduralApplyStudents will be able to critically review, consolidate and extend knowledge and thinking in relation to compliance with regulatory principles

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