When the original ICH E6(R1) was released in 1996, clinical trials were performed in a paper environment. At the time, AOL was the largest Internet Service Provider and YouTube, Facebook and DVDs did not exist.
Over 20 years of technological advances have reshaped the way we work. The proliferate use of scanners, email, shared drives and specialized research systems points to the fact that clinical trial organizations no longer operate in a purely paper-based world. Sites are now operating in a ‘hybrid environment’ consisting of both paper and electronic processes.
Recognizing that adoption of technology offers “new opportunities to increase efficiency,” ICH E6 guidelines have been revised to reflect two decades of technological changes. Among these changes, include updated standards regarding electronic records and essential documents.
Here’s how Complion helps clinical research sites meet compliance with ICH GCP E6(R2).