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 original data – 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:

1. Personal data protection evaluation – to check, if all data entered into the eCRF are prevented from possibility of patient identification
2. 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
3. Patient ID Number check – to evaluate if each patient has unique ID number, consistent with the numbering set up while designing the eCRF
4. Unscheduled, Follow-up visits check - to assess if designed database contains appropriate forms to manage with Unscheduled of Follow-Up visits, covered in the protocol.