Module 5

Regulatory Control of Clinical Operations

Aim

The purpose of this Module is to provide students with an understanding of the practical regulatory aspects of global clinical research, to enable them to provide effective advice on the regulatory issues likely to arise during clinical programmes.

Learning outcomes

  • Students will understand the practical aspects of Good Clinical Practice and how it supports clinical research.
  • Students will be able to identify the regulatory requirements for clinical research in major markets, understand the importance of the EU Clinical Trial Directive and the requirements and practicalities of preparing the required clinical trial applications and associated documentation.
  • Students will gain an insight into the complexities and requirements of pharmacovigilance in clinical research.
  • Students will be able to understand the management of clinical trial supplies.
  • Students will be able to understand the requirements of Good Manufacturing Practice, authorisation and importation of investigational medicinal products.
  • Students will be able to understand clinical trial reporting, the management of the data, data auditing and the practicalities of Good Clinical Practice inspections.
  • Students will gain an appreciation of the legal and ethical aspects of clinical research, including insurance, indemnity and the role of the ethics committees and safety boards.

Outline of Module topics

  • Investigational Medicinal Product Dossier (IMPD), Investigational New Drug (IND) and other clinical dossier requirements including the progression of clinical trials in relation to the toxicity programme.
  • Ethics Committees and Safety Boards
  • Clinical trial labelling, supplies management and Good Manufacturing Practice requirements
  • Pharmacovigilance of clinical trials
  • Clinical trial reports
  • Data management
  • Good Clinical Practice – Inspections, data auditing and compliance with the Declaration of Helsinki
  • Compassionate use/extended access
  • The legal aspects of clinical trials.

Links with other modules

  • Module 4 complements this Module, covering the needs of global clinical development and effective advice on the suitability of clinical programmes from a regulatory perspective.