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Additionally, 20% of the subjects were randomly selected for repeat data entry by another research assistant, and data discrepancies were resolved by independent source document verification by a senior medically-trained study team member.
In compliance with Good Clinical Practices (GCP), trial sponsors typically perform source document verification (SDV) of recorded data [36].
In the clinical trials arena, source document verification (manual comparison of the medical record to the CRF or database) although unproven, is generally thought to decrease data errors.
Data of included articles were extracted and entered into Microsoft Excel data files by one person; all entered data were subject to source document verification by another person.
Source document verification (SDV) was performed for 100% of core data (randomization, primary endpoint and SAE) and 20% of other data in this study.
As with any voluntary registry, incomplete or missing data may affect the results, though a recent analysis of the MPS I Registry using source document verification revealed an overall source-to-database error rate of <4%, with no systematic errors.
Similar(51)
Events were confirmed twice via source-document verification at site visits or delivered radiographic data by members of the data center and the investigators.
After opening, following the implant placement, the opaque envelope was kept as a source document for later verification against the randomization list.
Accordingly, whereas source laboratory documents verification is routinely performed by monitors and CRAs, assessment of laboratory performance with regards to SOP compliance, or of effective management and implementation of quality systems, is often beyond the scope of the standard monitoring process.
(See primary source document: Inaugural Address).
At "origination", they might include telemarketing, data entry and document verification.
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