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Clinical Data Management - Quality Assurance
Peachtree’s attention to quality is demonstrated by our aim to have a zero error rate on critical data and an overall data error rate of less than 0.1% which is more conservative than the industry average.
The following quality control procedures will be performed:
- Critical Variable QC - 100% QC (database versus CRF and DCFs) of all critical data items as defined in the Data Management Plan. All errors found will be corrected. The targeted error rate will be 0%.
- End of Study QC – 100% QC of every data point for a subset of randomly selected CRFs will be done. The acceptable error rate is less than 0.1%. Any error identified will be corrected. Should the error rate be exceeded a further random selection of patients will be selected and the QC process will be repeated until the required standard is met.
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