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