SOPs

The company has established and applies a Quality Management System according to ISO 9001:2015 standard. SOP index includes the important section of the SOPs which regulates Data Management activities as well as OnlineCRF system configuration and validation. This section entitled "DM" and it was developed in strict accordance with Good Clinical Data Management Practice standard (GCDMP). Our SOPs are not set in stone, but they are periodically reviewed and improved to be compliant to the modern requirements.

Code Name Version
SOP-DM-01Clinical Data Management2.3
SOP-DM-02Preparation of Data Management Plan2.5
SOP-DM-03Preparation of Business Requirements Document (BRD)2.6
SOP-DM-04Data Management Planning2.3
SOP-DM-05Incoming documents creation and development of functional requirement to EDC system2.7
SOP-DM-06Database Design2.2
SOP-DM-07EDC System Configuration2.2
SOP-DM-08EDC System Validation2.4
SOP-DM-09EDC System Verification2.1
SOP-DM-10Move EDC System to Production Mode2.4
SOP-DM-11Training for Investigators2.1
SOP-DM-12Move EDC System to Data Collection Mode2.1
SOP-DM-13Remote monitoring2.1
SOP-DM-14Data Cleaning2.3
SOP-DM-15Database Lock2.1
SOP-DM-16Sample Size, SAP, Statistical Report Preparation2.5
SOP-DM-17Archiving2.1
SOP-DM-18Backup Data Administration1.0
SOP-DM-19Statistics calculation1.0
SOP-DM-20Training in the system for the Sponsor1.0
SOP-DM-21Data Collection and Data Entry Process1.0
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