Veeva EDC - Local Labs Module

Managing Reference Ranges and Units Across All Your Studies

Laboratory reference ranges for any test or analyte are unique to each lab. Working with one or more labs at each site creates a burden on the sites and data managers to collect and manage the reference ranges and correlated units for every study. There is an additional burden on data managers to standardize the data and units across the study for reporting and analysis purposes.

Streamlining Work with Local Lab Data

Vault CDMS optimizes the site experience and data quality by creating a master list of units and range values for use across all your studies. Units of measure and laboratory normals are managed centrally in Vault CDMS. When entering results, sites simply select the lab location and Vault automatically loads the correct units and reference range. Sites only enter the collection date, time, and lab results - nothing else is required.

Business Benefits

• Minimizes Data Entry

  • Sites only enter the collection date, time, and lab results.
  • Selecting the lab location auto-populates range values and associated units.

• Maximizes Data Quality

  • Manage lab reference ranges in one place for the entire organization. Ranges entered in the master list are available for every study.
  • Updated range values are immediately available, minimizing the risk of making decisions on outdated information.

Features

• Clean, Intuitive Interface
  The modern UI is easy to navigate and use with little training needed. The local lab data is unified with Vault EDC administration, workflows, and case report forms.

• Centralized Tracking of Reference Ranges
  Enter lab normal information once and share it across all of your studies and sites.

• Data-driven Normals Selection
  Vault uses the patient demographic information such as age and gender to auto-populate the appropriate normal range data for that specific patient, laboratory, and analyte.

• Manual Override
  If authorized, sites may override the auto-populated range values for a particular analyte. Both sets of values are displayed.

• Reference Range Effective Dates
  Effective dates for lab normals ensure the correct ranges display for the given collection date.

• Pre-defined Units
  Vault automatically loads the appropriate units once sites designate the lab. No more selecting units from a dropdown list.

• Background Unit Conversions
  Vault maintains a library of unit conversion ratios and generates standardized results and units to accompany the original results and units in data extractions.

• Visual Indicators
  Visual icons indicate when results are outside of reference ranges. Sites can easily see which results need review for clinical significance.

• Analyte Library
  Vault provides a preloaded master list of all commonly used analytes.

• LOINC Code Support
  Comply with the FDA guidance to report LOINC codes with lab results by adding the appropriate LOINC codes within your analyte master list.

• Rapid Setup
  Upload lab locations and normal ranges from a spreadsheet template for easy deployment.

Changes to Lab Reference Ranges

Lab reference ranges will change due to a new testing method, a new analyzer, or a software update. With most EDCs, a site updates the normal range for an individual study, and every study and site using that lab needs to make the same update. Such a fragmented process introduces delays and increases the likelihood of error.

With Vault CDMS, the sponsor or CRO will update the lab reference range, including the effective date provided by the lab, and the new information is instantly available across all your studies. Vault then uses the effective date to generate a discrepancy report and flag impacted forms.

How changing UAT can save weeks during database builds.