The module gives an introduction into document management, quality management systems and biological sample management. It looks at the essential documents associated with clinical research and their functions, according to section 8 of the ICH GCP guidelines, and TMF. It also looks at the requirements for archiving, quality assurance and its role in clinical research (including continuous improvement), quality control checks, SOPS and their role in upholding regulations, compliance reports, and regulatory authority inspections. It also looks at the definition of a biological sample, and compliance with the applicable rules and laws for the collection, storage, and future use, of biological samples of clinical research subjects. Furthermore, it looks at the pros and cons of central vs local laboratories.
Blended distance learning:
Contact Hours: 100 hours
Private Study Time: 50 hours
Total Learning Time: 150 hours
Essay Assignment 50%
Portfolio 50% - composed of 5 individual assignments where topics are applied to the workplace
All assessments must be passed in order to pass the module
Reassessment: Like-for-like
See the library reading list for this module (Medway)
The intended subject specific learning outcomes.
On successfully completing the module students will be able to:
Make appropriate use of the essential documents associated with clinical research and their functions, according to the international conference on harmonisation (ICH) good clinical practice (GCP) guidelines and trail master files (TMF).
Understand the well-established requirements for archiving.
Apply the concepts and principles in quality assurance in clinical research.
Apply the concepts and principles associated with standard operating procedures (SOPS) and critically understand their role in upholding regulations.
Demonstrate knowledge and critical understanding of the well-established principles within compliance reports and regulatory authority inspections.
Understand what a biological sample is and how to comply with the applicable rules and laws for the collection, storage, and future use, of biological samples of clinical research subjects.
Critically evaluate the pros and cons of central and local laboratories.
The intended generic learning outcomes.
On successfully completing the module students will be able to:
Develop and demonstrate an ability to work and communicate effectively with others.
Analyse, evaluate and correctly interpret data
Present and communicate data effectively
Obtain and use information from a variety of sources as part of self-directed learning.
Manage their time and use their organisation skills within the context of self-directed learning.
University of Kent makes every effort to ensure that module information is accurate for the relevant academic session and to provide educational services as described. However, courses, services and other matters may be subject to change. Please read our full disclaimer.