Data JumpStart has been developed by Clinical Data Management Experts who also have practical experience with CDISC SDTM. This offering combines expert consulting with standardized libraries and templates that were developed based on practical experience. The documented standards enable the institutionalization of data management standards. The offering represents over 300 hours of expert development time by an SDTM knowledgeable resource with extensive data management experience. All deliverables are CDISC SDTM compatible.
The quick implementation of standards enables a company to evaluate a safety profile across studies and make go/no-go decisions more quickly and easily. And if you plan to outlicense, your organization can readily evaluate the safety profile in advance and provide an attractive data package to potential partners. When no standards are used, significant downstream costs (time and money) can be expected because large conversion efforts are required.
Data JumpStart includes the following deliverables:
Library of 18 Standardized CRFs
Annotated CRFs with SDTM variables in PDF format
SDTM compliant database specifications
Laboratory specifications for central lab vendors
Standard templates for Completion Guidelines, Validation Guidelines, and Edit Checks
Library of standard queries (approximately 40-50 queries that provide consistent, quality data and minimize re-querying). These queries support paper, fax and EDC studies
Data management plan template (~60 pages)
Sign off and approval sheets for CRF, Edit Checks, Database Release for Testing, and Completion Guidelines
Four hours of expert data management consulting
Standard Edit Checks for all CRFs included in the Data JumpStart package will be available in Version 2
