ICH E6 (R2) GCP Guidelines Issued for Review

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.