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Throughout all the phases of the projects, strict methods for quality control and data security are applied.
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CRF’s design and printing |
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the quality of data begins with a well designed CRF, where all the information required by the protocol is collected unequivocally. |
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Data Validation Plan |
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Key document in order to ensure quality management of data. It contains all the specifications for the study management and validation of data, from the document flow in and out to the list of all the checks and verifications on the data. |
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Database design, development and testing |
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The database development and maintenance are carried out in compliance with the standards required by the Sponsor. |
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Single/double data entry options |
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The data entry and check procedure is customized according to the Sponsors’ requirements. |
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Medical coding |
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Medical coding is carried out through MeDRA and WHO DRL dictionaries, or according to specific Sponsors’ dictionaries. |
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EDC :  Electronic Data Capture |
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Remote, via Internet o directly from electronic lab or diagnosis instruments or medical devices.
It can replace the data collection on paper CRF completely or in part.
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Validation check programming |
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The data internal consistency is accurately verified through SAS developed programmes. A “core” library of validated programmes ensures reproducibility and quickness in use. |
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Ongoing data consistency and credibility checks |
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On the basis of the control programme results, queries are generated and sent to the centres and the missing or not consistent data are corrected. This is an ongoing process. |
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Automated audit trails |
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At any time during the process, an electronic trail of the changes occurred to data is recorded. |
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Database release and lock |
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At the end of the process the database is declared clean and of quality. |
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Automated data delivery to SAS/SPSS for statistical analysis |
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Regular study progress reporting |
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According to deadlines and modality required by the Sponsor, administrative reports on the database state are written: N. of patients/ visits/ inserted or missing pages/N° of queries sent/solved and so on. |
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