The module gives an introduction into management of several important areas of clinical trials - document management, quality management systems and data management. It looks at the essential records associated with clinical research and their functions, according to section 8 of the ICH GCP guidelines, and Trial Master File (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 will cover database development, clinical trial specifications, and data management plans, to aid case repot form (CRF) design. It will also look at data coding, transfer and validation, including database reconciliation and user acceptance testing, and data listings and their review. It will show how to raise and resolve data queries effectively. It also covers some aspects of biological sample management 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.
Distant and Online blended learning: lectures, audio, recordings, video clips, study guides - 42 hours
'Live' contact hours: live teaching via webinars - 5 hours
Extended Writing Case Studies 1 worth 50% (1,500 words)
Extended Writing Case Studies 2 worth 50% (1,500 words)
All assessments must be passed to pass the module.
Reassessment: Like-for-like
1. Recognise essential clinical research records, according to GCP guidelines.
2. Apply key principles of clinical data management.
3. Understand and apply quality assurance principles in clinical research, including compliance.
4. Appraise handling of biological samples in clinical research, including legal and ethical considerations.
5. Critically evaluate the roles and performance of central versus local laboratories within clinical trial operations.
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