Guidance on User Acceptance Testing
Definitions
User Acceptance Testing (UAT) is a closing testing performed on a system that verifies the user needs and requirements, and evaluates the eligibility of the system to be accepted.
UAT is the set of processes of validationconducted on a system, to assess if the system works in the way that is claimed to work, and to prove that all user requirements are fulfilled.
User Acceptance Testing should be split into two levels: first level of testing should be conducted to determine if all functions of the system work as stated. Second level is to evaluate if the eCRF is compatible with the study protocol specifications.
User Acceptance Testing should be performed on designed eCRF undeniably, as mistakes made during creation of the database, if not corrected, could affect data storage and analysis.
UAT should be performed after the eCRF has been designed, revised and corrected by the study Team for the final sign-off.
Responsibility
The CI or delegate is responsible for conducting UAT, ensuring it fulfils CTSU Management requirements. As eCRF should be designed clearly, and in compliance with the protocol, UAT should check each clinical data set due to be collected during the study. UAT should be conducted for all possible roles of potential users participating in the study conduct.
User Acceptance Testing execution:
Minimum of tests (Level 1) performed on designed eCRF should be based on:
1.Requirement of entering the value –checking if the data needed to be entered is possible to be entered in a particular field
2.Format of values- checking, if all variables are of expected format
3.Range checks – checking if all variables are of expected ranges by using tests for values, which are:
- within expected range (approximately central value between two extremes)
- within expected range, but close to the extreme values
- within expected range, equal to extreme values
- beyond expected range, but very close to the expected extreme values
- far beyond expected range at both sides of extremes
4.Negative value check – to assess if any numeric data is not negative
5.Future Date Checks – to evaluate if the data fields forbid entering future dates
6.Multiple data fields – to check, if the fields that should be repeating during the study, work properly within different visits (i.e. Concomitant Medications, Adverse Events)
7.Duplicated data – to assess if any field was double - added incorrectly to the eCRF
8.Auto-queries – checking, if all queries set while designing auto-queries appear in the right position, under the proper circumstances
9.Confirmation of logic between particular fields – checking if all logic conditions are valid and work properly
10.Regression testing – checking, if changes in the structure of tested eCRF will not damage other parts of the system
11.Comparing extracted data to the originaldata– checking, if the data downloaded from the tested database, is the same as the original data, entered to the eCRF
Additional tests (Level 2) of User Acceptance Testing should include:
- Personal data protection evaluation – to check, if all data entered into the eCRF are prevented from possibility of patient identification
- Correction of lab values units and ranges – checking, if the lab values units in eCRF are correctly counted into standard international units, and if their lower and upper range values are compatible with standards
- Patient ID Number check – to evaluate if each patient has unique ID number, consistent with the numbering set up while designing the eCRF
- Unscheduled, Follow-up visitscheck – to assess if designed database contains appropriate forms to manage with Unscheduled of Follow-Up visits, covered in the protocol.
SOP 38b– Associated Document3 UAT Testing V1.0 11/4/16Page 1 of 1