15 October 2015

ICH E6 (R2) GCP Guidelines Issued for Review


A new draft of the ICH GCP guideline has been modified to address the following:

  • data integrity
  • electronic records and controls
  • 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
  • risk based monitoring
Download the new guideline here

No comments:

Post a Comment