SCLRC holds Master Agreements with our consortium sites. Our Master Agreement template includes our standard research guidelines that agree with the guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and FDA regulatory requirements in 21 CFR 50.23. If a site provides their own guidelines, they are verified to be in agreement with ICF and FDA regulatory requirements in 21 CFR 50.23.
Consistent Research Guidelines