A compilation of key requirements and guidelines with a unique index that allows the user to search the key requirements for the appropriate sections using subject index and key words.
Clinical Research in Europe is controlled by a raft of legislation and guidance. This publication brings together the globally accepted ICH GCP guidelines, the three major EU Directives affecting clinical trials, Annex 13 relating to investigational medicinal products and the 1996 and 2013 versions of the Declaration of Helsinki
This wire bound A5 size book opens flat for easy reading. It is an ideal reference guide for everyone involved in human clinical research including Sponsors, Investigators, Trainers, Auditors and others needing regular and rapid access to the key requirements
Its 174 pages, contains copies of the following guidelines/requirements, all cross referenced in a unique index:
ICH GCP Guidelines: E6 (R2)
Directive 2001/20/EC (including amendments since 2001)
Annex 13 (July 2010)
Declaration of Helsinki 1996 and 2013