CRP 109 Lecture 4

Question 1

Data Queries

Answer 1

Ensure data integrity & improve data quality by raising attention
to data that are out of the expected range, inconsistent, illogical
or discrepant

Question 2

Edit Checks

Answer 2

• Increase efficiency and data quality by automating data review
  processes
• Design edit checks based on parameters of the CRFs and the
  parameters of the protocol, e.g.
• Inclusion and exclusion criteria
• Study endpoints/efficacy
• Safety data
• Range checks
• Missing values
• Develop library of standard CRFs and edit checks
• QC review of edit check design and specifications before UAT

Question 3

Data Validation

Answer 3

 Validation of software system or study-specific database prior
to its release for operational use
 Develop a validation plan to ensure database will operate on
clean, correct and useful data
 Complete at database design stage
 Sponsor’s responsibility
-QA/QC mechanisms ensure data are generated and processed
in compliance with the study protocol and GCP requirements
 UAT is one element of validation process

Question 4

Data Validation Specification

Answer 4

-i.e. making sure EDC is automatically raising prompts and queries as required for invalid data
 Part of the validation plan – define the test methodology,
problem reporting and resolution, acceptance criterion
 Document with details of the testing of every edit check using
‘good’ and ‘bad’ dummy data
 Responsibility of the eCRF build team (qualified staff)
 Critical step; ensures edit checks are all defined and
functioning properly
 Edit checks can prevent illogical, incomplete, or inconsistent
data from being entered into eCRFs – makes downstream data
analyses easier

Question 5

UAT

Answer 5

 The testing of eCRFs to assess if the system works in the way
that it is claimed to work, and to prove that all user
requirements are fulfilled
 All components are tested on a per study basis – data entry,
monitoring/source data verification/query process
 Findings are documented and reviewed by the eCRF build
team for feasibility
 Outcomes are documented in a UAT report whether changes
are implemented or not
 Study build team and testers sign to authorize acceptance of
the report