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The US Food and Drug Administration is now accepting electronic regulatory submissions in eCTD format and recommends that the clinical data sets be submitted in Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) compliant format.

Traditionally, the effort to generate compliant data sets has taken significant time and the validation process is usually riddled with errors due of human intervention.

CheckPoint is Octagon's innovative software solution that addresses the tedious, manual and labor-intensive process of validating data for CDISC SDTM Compliance. CheckPoint automates these tasks and simplifies the effort so that your team can identify errors and issues of non-compliance before data is submitted to the agency.

CheckPoint functionality:

  • Implements the 105 CDISC SDTM data validation rules plus 4 Janus checks created by the FDA Data Standards Council
  • Creates annotated CRFs required for electronic regulatory submissions to the US Food and Drug Administration
  • Generates standards-compliant define.xml file for electronic regulatory submissions to the US Food and Drug Administration

CheckPoint Validation Checks

CheckPoint supports 109 standard validation checks based on the SDTM Implementation Guide. CheckPoint may also be configured to perform 217 enhanced checks for a more comprehensive approach to data validation. Resulting web-based reports provide summary information for project management use and drill-down capability for more detailed programming needs. The combined checks address seven key areas including consistency, format and meta data.

Annotated CRF Functionality

CheckPoint utilizes metadata such as page number and variable and places appropriate electronic annotations on a blank CRF to associate each item on the CRF to variables in the database.

Define.xml Functionality

CheckPoint generates standards-compliant define.xml, which is a data definition file that describes the format and content of the submitted datasets required for electronic submissions to the US FDA.

Octagon's Regulatory and Clinical services teams rely on CheckPoint to ensure that compliant data deliverables for electronic submissions are produced quickly and efficiently. This proven solution reduces time, decreases resources and facilitates compliance with industry standards.

Looking to outsource data validation activities?

Octagon also provides CheckPoint data validation services, utilizing CheckPoint in an innovative outsourcing model.

For more information download pdf of CheckPoint Data Validation or Contact Octagon.