Definitions

User Acceptance Testing (UAT) is a closing test 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 validation conducted 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.

SOP 38b Associated Document 3 - User Acceptance Testing

The following has been taken from SOP 38b AD 3, for more information please click here