This represents a significant shift away from previous guidance. The renovated document is a principles based guideline that has quality deeply embedded in its message, in close alignment to what we can expect to see with ICH E8 (R2). Annexes 1 and 2 are not yet released, and public consultation has not yet begun. For now, the working group have enabled us to contemplate how our approach to #GCP will change to ensure that participant welfare is our focus, and that quality (the absence of errors that matter) is deeply enshrined in our design and practice.
It’s a forward looking document, and it calls out a new era in #clinicaltrials.
Next steps are public consultation and then adoption. For now, it’s status quo.
Link to guidance: https://lnkd.in/g6JM4uc