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About This Item
The Guide is designed to provide a valuable tool for the development of in-house 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
- Distribution and Returns