• Terms and definitions

Terms and definitions

A number of terms and acronyms are used throughout the QuBAS software and documentation.
Analysis Definition
The Analysis Definition defines all the analysis details including type of statistical model, model parameters, outlier management, system and sample suitability criteria (optional).
There is only one Analysis Definition per Method, but multiple versions may be held in the version controlled Development Report system.
Analysis Engine
In QuBAS, the Analysis Engine is the software component which performs the requested analysis on a dataset and generates the Analysis Report.
Audit Log
There are three Audit Logs that each record different types of activity in the QuBAS system:
•      The Validation Audit Log which records all the real time validation information.
•      The System Audit Log which records all user access and actions within the system.
  •      The Analysis Audit Log which records all the information necessary for QA sign off (approval) of the analysis report. This Audit Log is appended to the Analysis Report and can also be viewed in the Audit Room. 
    In general, QA staff should access the audit records via the audit room which is designed to provide the key audit details in a searchable format.
Data File Template 
The Data File Template is a user defined template that acts as a stencil that the system lays over an imported   data file to identify which entries in the file are the experimental data values  and which are other information such as sample IDs, operator ID, lab ID etc, known as Metadata. 
Data Map
The Data Map defines the details of the various types of experimental data within the Data File.
  •      Type of data, i.e. reference, sample, QC or control
  •      Dose (or dilution) associated with each experimental value
If the data is from a standard plate reader, this is in effect the plate map. The term Data Map is used in QuBAS because the system can also be used to analyse data from in vivo studies where the term ‘plate map’ may not be relevant.
Only one Data Map can be associated with a Method, but multiple versions may be held in the version controlled system. 
Development Report
The Development Report is an incremental file (one per Method) which updates automatically every time a user wishes to store a particular version of the Data Map and/or Analysis Definition created for the Method during development (or after a Method version upgrade).
The Development Report can be exported at any time and can be edited and used as part of the formal bioassay development report for regulatory purposes. 
The Development Report contains hyperlinks allowing the user to select any previous Data Map and Analysis Definition versions and set them as the current working version.
Diverse Self-Checking Pair (Programming)
DSCP programming is key to the Continuous real time Validation (CrtV)  process that allows QuBAS to be installed and used without traditional installation, operational and performance qualification (IQ, OQ and PQ).
Metadata is all the information about an assay
Substance Metadata: The names / identifiers for the substances on the plate (Reference, test items, control items etc)
Method Metadata: Other information about the assay e.g. operator ID, critical reagent lot number etc.
The term Method is used by QuBAS as the name under which to group all associated development and routine analysis files and folders. 
The Method can be updated to reflect a new version as required. The older versions remain available to users with appropriate sign off authorisation.
Method Configuration File
The Method Configuration File is created when a QuBAS Method is signed off (approved) as suitable for routine use.
The Method Configuration File is a read only file created by a DSCP process that contains all the information required to read and analyse an imported  Data File (i.e. the information from the  Data File Template, Data Map and Analysis Definition). It also contains audit information about the sign off process for the Method. 
It is version controlled to allow an updating of the Method at a later time.
The Method Configuration File and a Data File are all that are required to recreate the analysis.