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Overview Overview
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Quality control of data entry Quality control of data entry
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Corrections to database Corrections to database
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Completing the coding of data Completing the coding of data
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Regular examination of the database Regular examination of the database
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Locking and unlocking the database Locking and unlocking the database
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Cite
Extract
Overview
It is recommended that data be checked, queried, and corrected while the trial is being conducted. It is considerably easier to investigate potential errors in the database as soon as possible after the data have been collected. Therefore, whether paper collection or electronic data capture is used this requires data to be entered into the database with minimum delay. Data entry and management should be an ongoing exercise, which should only rarely be left until the completion of the actual conduct of the study. If data are queried promptly, problems can often be resolved quickly and easily. Therefore, regular checking of the database is essential.
Quality control of data entry
When data are entered from paper case report forms it is important to check the quality of the data entry to ensure that the information in the database agrees with what is recorded on the form. The data entry error rate may be considerably reduced by using double data entry where the same information is entered twice and then compared for inconsistencies. However, as this requires double the resource, single data entry is often preferred. In this case a planned procedure is necessary whereby a chosen percentage of the case report forms are compared with the data entered into the database. A high number of errors would prompt a larger sample to be checked or the data should be entered again in full.
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