QuBAS System
The diagram below shows an overview of the QuBAS system, detailing the two complementary program elements Explorer and Regulatory.
The login area and the import room are common to both elements: The Explorer package is used for developing the analysis and exploring the consequences of different statistical methods and suitability criteria. The Regulatory element of QuBAS is used for creating a GxP and 21 CFR part 11 compliant standard analysis report. The method, created by the R&D user, can be approved and locked down so that it can be used securely by a Routine user. The Routine user simply imports the data, selects the locked method created by the Sign off user and presses go to produce the GxP and 21 CFR part 11 compliant report.
User Permissions
The table below details the different user profiles available for both the Explorer & Regulatory elements of QuBAS along with the permissions for each.
| User | Admin (Explorer) | R&D (Explorer) | Routine (Regulatory) | Sign Off (Regulatory) | Àudit (Regulatory) |
|---|---|---|---|---|---|
| Method management | |||||
| Create New | |||||
| Modify Method Meta Data | |||||
| Import room | |||||
| Import Data File | |||||
| Design New DFT | |||||
| Add Meta Data (if not present in data file) | |||||
| Explore room | |||||
| Create / Edit Data Maps | |||||
| Create / Edit Analysis Definitions Including All Suitability Criteria | |||||
| Manage Versions of Data Maps and Analysis Definitions | |||||
| View Data | |||||
| Run Analysis | |||||
| Download Report (Not for GxP use) | |||||
| Download Excel Format Results | |||||
| Create Entry In Development Record | |||||
| Submit A Fully Developed Method For Sign Off | |||||
| Sign Off Room | |||||
| Authorise A “Method” For Use In Routine / Regulatory Studies. Creates Locked Method Configuration File (MCF) | |||||
| Download MCF for paper records | |||||
| Routine Room | |||||
| Run An Analysis Using A MCF On A Selected Data File | |||||
| Download Report For Regulatory Use (GxP , 21CFR Part 11 ) | |||||
| Audit Room | |||||
| Read Audit Logs | |||||
| Admin Areas | |||||
| User Invitation | |||||
| Management Update Licence | |||||
| Create System Meta Data | |||||
| Auto Log Out Setting | |||||
| System Validation Checks In Routine Mode | |||||
| View IT Environment Report | |||||
| View System Level Audit Logs |