FEATURES BRIEF

Managing Reference Ranges andUnits Across All Your Studies
Laboratory reference ranges for any test or
analyte are unique to each lab. Working withone or more labs at each site creates a burden
on the sites and data managers to collect andmanage the reference ranges and correlated
units for every study. There is an additionalburden on data managers to standardize thedata and units across the study for reportingand analysis purposes.

Streamlining Work with Local Lab DataVault 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 enteringresults, 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 themaster list are available for every study.
• Updated range values are immediately available, minimizing the risk of making decisions onoutdated information.

FEATURES BRIEF

Features
Clean, Intuitive Interface

Background Unit Conversions

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.

Vault maintains a library of unit conversion ratios andgenerates standardized results and units to accompany
the original results and units in data extractions.

Centralized Tracking of Reference Ranges

Visual Indicators

Enter lab normal information once and share it across allof your studies and sites.

Visual icons indicate when results are outside of reference
ranges. Sites can easily see which results need review forclinical significance.

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.

Analyte Library

Manual Override

LOINC Code SupportIf authorized, sites may override the auto-populated
range values for a particular analyte. Both sets of values
are displayed.

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

Reference Range Effective Dates

Rapid Setup

Effective dates for lab normals ensure the correct ranges
display for the given collection date.

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

Vault provides a preloaded master list of all commonlyused analytes.

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

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 adiscrepancy report and flag impacted forms.

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