This ‘carry-around’ pocketbook contains the changes to ICH GCP E6(R1) brought about by the Integrated Addendum E6(R2). This was published by ICH as a Step 4 document in November 2016.
The book contains a unique index (compiled by Prof David Hutchinson) that allows the user to search for the appropriate sections using subject index and key words.
It is ideal for investigators, monitors, auditors, regulatory authority inspectors, members of ethics committees and others who need regular access to the GCP guidelines.
First Edition: November 2016
Also available as an e-publication for iPad/iPhone and as a PDF for android and PCs.