Clinical Material (CM) supply chain management is an ever-expanding and complex field. Government agencies require that staff members are fully trained in the appropriate regulations and GMPs, and keeping current with the rapidly changing global landscape may present a considerable challenge. The ISPE Comprehensive Guide to Clinical Materials offers guidance in this demanding area.

The Guide is designed to provide a valuable tool for the development of inhouse training sessions for advanced training, building on the topics covered in the earlier Introductory US Clinical Trial Materials Training Guide’ (ISPE 2002).

The Guide may be used in a classroom setting and then by attendees to gain a more in-depth knowledge and as reference source for future use.

The Guide is divided into sections focusing on:

• Critical learning points summarized for trainer led sessions, written concisely in bullet format.
• Detailed information addressing each of the critical learning points and reasons for their importance - for background and more in-depth knowledge.
• Reference sources to provide a comprehensive knowledge base.

The Guide has been developed by the ISPE Clinical Materials Community of Practice, including members of the European Investigational Medicinal Products Group (IMPG). This is reflected in a more global approach to regulatory aspects, which include:

• The Common Technical Document (CTD)
• Relevant cGMPs
• New EU Regulatory Environment

Other sections of the Guide consider:

• Project Planning and Management
• Clinical Trial Design
• Manufacturing
• Distribution and Returns