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Data Validation Plan


What is the main goal for data validation? Improvement of data quality
How can data quality be improved through data validation? *Detect & correct discrepancies *ID protocol deviations *Recognition of data manipulation during study conduct
Some synonyms for Data Validation validation plan, data validation plan, data edit checks, data validation specificaion (DVS)
Define data validation plan a system of rules, how to check each data field in the clinical DB against protocol requirements
Targets of data validation To ensure thta data in DB is: clean, correct, valid, plausible
What is needed in order to write a data validation plan? Knowledge about the required elect. data: format, frequency, field length, repeated measurements
Where can we find info regarding data validation plan? -Study protocol _CRFs -Mock CRF
What are the 3 main groups contributing for the reconcilliation of data validation DB? -Monitor -Data manager -Statitician
5 steps for QC of data validation plan: 1)the 3main groups 2)test CRF & test output 3)Output control 4)query statistics 5)In process review
What is the structure of the data validation plan? *Cover *General part *Individual part
DVP: Content *every edit check to be listed *Critical data highlighted *diferentiation b/w manua and program checks *Query text
What happens after the approval of data validation plan? *Dat acleaning specifications *Query format & handling guideline
Created by: marlice