MSc Pharmaceutical Industrial Advanced Training (PIAT) / Course details

Year of entry: 2020

Course unit details:
Introduction to Clinical Trials (CT1)

Unit code PHAR72010
Credit rating 15
Unit level FHEQ level 7 – master's degree or fourth year of an integrated master's degree
Teaching period(s) Variable teaching patterns
Offered by Pharmacy
Available as a free choice unit? No

Overview

This introductory module provides an overview of the basic requirements and procedures employed in planning and conducting clinical trials. It also provides guidance on ethical, regulatory and statistical aspects as well as the managerial requirements. 

Aims

The unit aims to provide the learner with the content and support so that they can:

 

  • Acquire and develop an advanced knowledge and in depth understanding of the theory of setting up and running clinical trials
  • Acquire and develop the advanced skills to make an effective contribution to clinical trial practice
  • Demonstrate the ability to analyse the different clinical trial phases and the purpose of each
  • Identify their own learning needs, develop themselves as critically reflective practitioners and advance their own learning to sustain continuing professional development
  • Critically evaluate literature, theories and methodologies and apply approaches to creating a clinical trials project plan

 

Teaching and learning methods

This module is delivered entirely through distance learning. A printed manual consisting of ten chapters is issued to the student on registration and receipt of payment. Each chapter is designed to contain ten hours of assessed learning.

Additional learning activities are directed which, together with the assessment, require 50 hours of self directed learning and assessment.

Knowledge and understanding

Self-directed learning

 

Practical skills

Reflective diary

Peer review

Self-directed learning

 

Transferable skills and personal qualities

Group work

Work based learning

Self-directed learning

 

Knowledge and understanding

Students should be able to: 

Demonstrate an advanced knowledge and detailed understanding of the:

  • historical background of how clinical trials have developed and evolved to modern standards
  • drug development process
  • basic requirements for developing and conducting clinical trials
  • practical and theoretical aspects of the design, conduct, analysis of outcomes and reporting of clinical trials
  • ethical and regulatory aspects of the proper conduct of clinical trials

Intellectual skills

Students should be able to: 

Critically analyse, evaluate and where appropriate formulate an informed opinion about:

  • Clinical trial reporting
  • Impact of poor practices in clinical trial conduct
  • Effectiveness of current systems and processes

Practical skills

  • Analyse approaches to project management
  • Offer guidance on Project Management in Clinical Trials, including Project Management Tools and how to use them effectively, and how to
  • Plan approaches to manage when things don’t go as planned, for example when there are unexpected outcomes or accidents in the conduct of clinical trials
  • Complete practical exercises to demonstrate an understanding of the application of knowledge derived from the course material
  • Engage in critically reflective practice as a process of continuous personal development
  • Network with key stakeholders in own organisation to drive processes forward based on knowledge gained through course participation

Transferable skills and personal qualities

  • The ability to critique information from a range of sources to formulate opinions
  • Project manage in accordance with organisational requirements, demonstrating high level knowledge on a process driven approach
  • The ability to assess current working practices based on knowledge and experience gained and adapt working practices as necessary
  • The ability to prioritise and effectively manage time to complete work by required deadlines

Assessment methods

Method Weight
Written assignment (inc essay) 100%

Feedback methods

Marks and feedback sent by email within 15 working days

Study hours

Independent study hours
Independent study 150

Teaching staff

Staff member Role
Glen Clack Unit coordinator

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