15 Golden IND/GCP Rules for Investigators


15 Golden IND/GCP Rules for Investigators
Product Code: 15 Golden IND/GCP Rules for Investigators
ISBN: 9781912055036
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*****  ICH GCP E6 (R2) compliant  *****

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by Prof David Hutchinson

The code of Federal Regulations (21 CFR Part 312) applies to all studies performed in accordance with an Investigational New Drug Application (IND) in the USA. In addition, Good Clinical Practice (GCP) is a global quality process that is applied to the conduct of all clinical trials on new medicinal products. Study investigators, including physicians and other healthcare professionals at all levels of experience, have GCP responsibilities, but most researchers do not full understand what this involves. Investigators who do not work in accordance with GCP will be unable to perform trials on new products in the future.

This quick and easy to read, illustrated, 'bullet point' guide to IND requirements and ICH GCP is ideal for investigators and other members of the study team.

This popular book will help investigators comply with ICH GCP investigator responsibilities and items on the monitor's wish list. The book contains relevant extracts from the guidelines.

It presents 15 golden rules for investigators and members of the study team who need to be aware of their responsibilities when performing a trial in accordance with the US Investigational New Drug (IND) application requirements (21CFR Part 312).

Sample Pages

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