Help is Here: Interpreting the ICH E6 R3 Data Governance Requirements

About this session

Session: DRIVING SCALABLE INNOVATION

The upcoming ICH E6 R3 (GCP) guideline introduces a brand-new section related to Data Governance in clinical trials. Given the critical nature of data in clinical research, proper governance is essential to maintain the reliability of the trial results, the protection of the participants’ rights and safety and to ensure compliance with regulatory requirements. ACRO and TransCelerate collaborated to deliver a Data Governance framework and diverse solutions to support the understanding and interpretation of these new requirements. This session will help interpret this new GCP guidance for those involved in clinical data and GCP auditing.

Speaker

• HL

  Hasnaa Likaoui

  Dir · Bristol Myers Squibb SA

  Speaker