The ICH GCP guidelines have been modified to address the following:
- electronic records and controls (reflects 21CFR Part 11 requirements)
- validation of computer systems used for GCP
- risk management approach on behalf of the sponsor and the CRO to evaluate, identify, control, mitigate, and communicate the major risks
- oversight responsibilities of the sponsor
- integrity of the data (the new FDA hot button)
- risk based monitoring
Download the guidelines here.