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Observational Studies

Data management

  


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Last update:
2010-09-01 11:49
 
 

 

  • Review of incoming study documents (questionnaires, case report forms).
    Optional: web-based remote data entry.
  • Management of adverse event (AE) reports, assessment by in-house physician, forwarding of AE lists resp. data to sponsor's drug safety department.
  • Data capture, incl. coding by means of customary international coding systems (MedDRA, WHO, COSTART, ICD-10) as agreed with sponsor.
  • Data cleaning, incl. plausibility checks.
  • Flexible database formats, as agreed with sponsor.

 

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