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PPCE carries out Clinical Data Management activities for paper-based, electronic data capture trials as well as hybrid studies.
We identify four important areas of difference between electronic and paper based studies:
- the manner in which data will be collected - timelines necessary to prepare for the study - the manner in which collected data will be verified, and - disaster recovery planning. |
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CDISC is ‘a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata.
The aim of CDISC is to ensure that data from clinical trials is submitted in a clear, consistent and standardized format that allows |
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