QuBAS System

The diagram below shows an overview of the QuBAS system, detailing the two complementary program elements Explorer and Regulatory.

QuBAS System

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.

UserAdmin (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