Take 12 GCP Rules and add IND rules for investigators doing US IND trials.     

This quick and easy to read, illustrated, bullet-point guide breaks down IND requirements and ICH GCP into 14 digestible and bite-size chunks, the ‘golden rules’. It will help investigator site personnel comply with ICH GCP investigator responsibilities and the US Code of Federal Regulations 21 CFR Part 312, which applies to all studies performed in accordance with a US Investigational New Drug Application (IND).  Updated to be fully compliant with ICH GCP E6(R3)