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-01 | Clinical Data Management | 2.3 |
| SOP-DM-02 | Preparation of Data Management Plan | 2.5 |
| SOP-DM-03 | Preparation of Business Requirements Document (BRD) | 2.6 |
| SOP-DM-04 | Data Management Planning | 2.3 |
| SOP-DM-05 | Incoming documents creation and development of functional requirement to EDC system | 2.7 |
| SOP-DM-06 | Database Design | 2.2 |
| SOP-DM-07 | EDC System Configuration | 2.2 |
| SOP-DM-08 | EDC System Validation | 2.4 |
| SOP-DM-09 | EDC System Verification | 2.1 |
| SOP-DM-10 | Move EDC System to Production Mode | 2.4 |
| SOP-DM-11 | Training for Investigators | 2.1 |
| SOP-DM-12 | Move EDC System to Data Collection Mode | 2.1 |
| SOP-DM-13 | Remote monitoring | 2.1 |
| SOP-DM-14 | Data Cleaning | 2.3 |
| SOP-DM-15 | Database Lock | 2.1 |
| SOP-DM-16 | Sample Size, SAP, Statistical Report Preparation | 2.5 |
| SOP-DM-17 | Archiving | 2.1 |
| SOP-DM-18 | Backup Data Administration | 1.0 |
| SOP-DM-19 | Statistics calculation | 1.0 |
| SOP-DM-20 | Training in the system for the Sponsor | 1.0 |
| SOP-DM-21 | Data Collection and Data Entry Process | 1.0 |
