Data Validation Specifications

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DATA VALIDATION SPECIFICATIONS (DVS)

The DVS is a technical document that details unique forms and fields, visit structures, dynamic rules, calculations, edit check logic and query text. The DVS must align with other critical study documents and specifications. Data Validation Specifications are considered by many data managers to be the “Bible” for the clinical data management of the study.  All system checks as well as protocol specific edit checks are outlined within the DVS.  Query text should be logical, instructional yet non-leading, consistent with protocol requirements, and be in alignment with Case Report Form Completion Guidelines.

A comprehensive, well designed DVS is critical in the downstream quality of data output.  The quality control of these specifications before the clinical database goes live is painstaking yet ESSENTIAL.

CDM TASKER can help you by reviewing the DVS for you and provide insight into enhancements that may be needed BEFORE it is placed into production.  Rely on the expertise of CDM TASKER to ensure that your clinical data management specifications and database are of the highest quality.

 Questions? Contact CDM TASKER anytime at info@cdmtasker.com or dial 508.333.1279.