Data Management personnel are responsible for creating, collecting, maintaining and/or retaining all essential study documents when contracted by the sponsor (e.g. biotech company, big pharma client).
It is important to keep electronic and paper records or hard-copies and specify retention records of these essential documents:
- Final version including amendments of the clinical protocol
- Final version of the CRF/eCRFs
- Final version of the completion guidelines
- All final approvals and written authorization (e.g. emails or note to files).
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Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, Medrio, IBM eCOS, OpenClinica Open Source and Oracle Clinical.