In November 17, 2016, the International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use (ICH) released E6 R2 which tries
to address some of major developments in technology, medical breakthroughs and
business processes – taking into account unprecedented yet justified
expectations by regulators, patients, investigators and caregivers.
The eCF webinar explored what was removed and discussed some of the
opportunities and challenges presented by additions to the E6 text:
How to eliminate
sponsor control over Investigator entries/Source data? Where did the
contemporaneous investigator copy go and should we forget all about it?
How to develop and
document risk-based approaches to monitoring in order to protect reliability
of trial results (Data Integrity)? How to develop monitoring plans which
describe the strategy, methods, responsibilities, and requirements for
monitoring the trial?
CSV formally makes
its way into GCP in a more prescriptive manner than ever before – too late,
Slides used during the event can be downloaded by eCF members from the Members
area of the website.