Clinical Sites SOPs
EVICR.net has developed a Quality System for its members which is based on the ICH-GCP Guidelines. All our Clinical Sites Members agree to adopt and implement Standard Operating Procedures (SOPs) in their Centres that will be checked before they are certified as Sites of Excellence.
These 6 SOPs are:
• SOP ECR 500 - Template for Clinical Sites: Preparation, Approval, Distribution, Revision and Withdrawal of SOPs (Master SOP)
• SOP ECR 501 - Human Resources Management: Staff Responsibilities, Functions and Training
• SOP ECR 510 - Pre-Study Activities
• SOP ECR 511 - In-Study Activities
• SOP ECR 512 - End-of-Study Activities
• SOP ECR 530 - Infrastructures Management
The implementation of these 6 organizational SOPs will permit the Clinical Sites to have a standard way of working and in compliance with ICH-GCP Guidelines when performing clinical trials. Since they are common to all members it is a platform to perform Investigator Initiated Research or Industry-Driven Clinical Trials within the Network.