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Data Validation Plan
CDM
| Question | Answer |
|---|---|
| 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
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