Sample Management Analytics (SMA) supports trial sample tracking, reconciliation, informed consent and sample destruction tracking, visualization, and reporting. SMA provides visibility into the collection, movement, storage, reconciliation, consent status, and destruction status of clinical samples, including biological samples, EKGs, and radiology samples.

SMA Key Features

• Sample Tracking: Monitor sample collection, movement, location, storage, and processing throughout the sample lifecycle.
• Reconciliation: Review reconciled and unreconciled sample data and identify data anomalies.
• Informed Consent Tracking: Monitor informed consent coverage, validity, and associations between informed consent forms (ICFs) and samples.
• Sample Destruction Tracking: Monitor sample destruction status with related informed consent and retention policy information.
• Collection Schedule Tracking: Review expected and collected samples and monitor sample collection schedules.
• Reporting: Create configurable reports of sample locations and sample details.
• Sheet Customization: View standard SMA sheets or create private and community sheets using data available in the SMA data model.

In the Sheets panel, SMA sheets are organized into the following categories:

• Informed Consent
• Sample Tracking
• Collection Schedule
• Data Quality
• Reporting

The Home Page is available separately from these categories.

Use the filters at the top of each sheet to refine the displayed data.

Tip: Applied filters remain when navigating between sheets. Clear a selection from the Selections toolbar to remove the filter.

Click the Home icon on any sheet to return to the Home Page. The Home icon does not display on the Home Page.

Hover over the top-right corner of a visualization, then click the Full screen icon to view all data and legends.

Important: The list of sheets does not include custom sheets specific to your organization.

Sample Management Analytics (SMA) Home Page

The Home Page provides an overview of sample management activity across all studies, including sample collection, movement, storage, reconciliation, and data quality.

The Home Page includes the following KPIs:

• Total Studies, Sites & Subjects
• Sample Types & Total Samples
• Samples On Query
• Duplicate Samples
• Unreconciled Samples
• # of Data Anomalies

The following KPIs provide direct access to related SMA sheets:

• Click Sample Types & Total Samples to open the Sample Details by Collection Status sheet.
• Click Unreconciled Samples to open the Unreconciled Samples sheet.
• Click # of Data Anomalies to open the Data Anomalies sheet.

The Home Page includes the following visualizations:

• Collection Status and Schedule Status are available in a tabbed view.
• Samples by Last Status
• Samples by Type
• Samples by Current Location
• Samples by Collection Schedule

The Derived Sample Histories table provides sample-level details.

Informed Consent Overview

Use the Informed Consent Overview sheet to review informed consent form (ICF) coverage, validity, sample associations, and retention requirements.

The sheet includes KPIs and visualizations that compare:

• Subjects with and without ICFs
• ICFs with and without associated samples
• Samples with and without an associated ICF
• Valid and invalid ICFs

Use the following tabbed tables to investigate consent and sample relationships:

• Sample Histories
  • All Samples
  • ICF-Matched Samples
• Informed Consents & Retention Policies
  • Sample-Matched ICFs
  • Unmatched & Invalid ICFs
  • Retention Policies

Sample ICF Tracking

Use the Sample ICF Tracking sheet to review sample-level informed consent form (ICF) collection status across studies and sites.

The sheet includes:

• Total Samples by ICF Collection Status displays samples by ICF collection status. 
• ICF Status by Study and ICF Status by Site are available in a tabbed visualization. 
• The ICF Collection Status by Study, Country, and Site pivot table provides detailed comparisons across study, country, and site.

Sample Flow

Use the Sample Flow sheet to view the journey of samples from the site to the final destination. Samples are displayed by site, sample type, intermediate location, and destination.

If multiple studies are available, select one study to display the sample flow.

• Hover over a site to view the total number of samples for that site.
• Hover over a location bar to view the total number of samples tracked at that location.

Sample Details by Collection Status

Use the Sample Details by Collection Status sheet to review sample collection and schedule status across studies, sites, visits, and sample types.

The sheet includes visualizations for collected and uncollected samples and collection schedule status. Use the Raw Sample Data table to review sample-level details.

Sample Details by Location

Use the Sample Details by Location sheet to review sample locations, movement, and processing timelines.

• The Total Samples by Current Location pie chart displays the distribution of samples by current location.
• The following combo charts are organized in a tabbed view. Click a tab to display the corresponding sample movement or processing metrics:
  • Samples and Avg Days in Transit, displayed by default
  • Samples and Avg Days at Intermediate Location
  • Samples and Avg Days to Process

The Derived Sample Histories table provides sample-level history and location details.

Sample Details by Sample Status

Use the Sample Details by Sample Status sheet to review the last reported status of samples and identify warnings and losses by site and location.

The sheet includes visualizations that compare sample status and status categories by sample type, site, and location. The Derived Sample Histories table provides sample-level status and history details.

Current Sample Locations

Use the Current Sample Locations sheet to review the current location and distribution of samples.

• Use the Duration Threshold drop-down to highlight samples that have remained at a location longer than the selected number of days. 15 Days is selected by default. Select 30 Days, 45 Days, or 60 Days to change the threshold. Samples that exceed the selected threshold are highlighted in yellow.
• Use the Display Sample IDs drop-down to determine whether Sample IDs display in the Current Sample Locations table. No is selected by default.
• The Current Sample Counts by Type and Location table displays sample counts by sample type and location.

Subject Overview

Use the Subject Overview sheet to review sample collection activity for a specific subject. Select one study and one subject to display data.

The sheet includes the following tables:

• Subject Status provides subject status and disposition information.
• Active Schedules displays scheduled sample collection visits for the selected subject.
• Actual Visits displays visits derived from available data sources, including EDC and manifests.
• Collected Samples provides collected sample details, including sample type, visit, collection date, and location.

Sample Destruction Status

Use the Sample Destruction Status sheet to review scheduled sample destruction and identify samples with completed or overdue destruction.

The sheet includes the following visualizations:

• Total Samples by Destruction Status
• Destruction Status by Location
• Destruction Status by Sample Type

Use the Sample Destruction Status, Informed Consents, and Retention Policies tables to review sample destruction details with the associated consent and retention requirements.

Schedule Overview

Use the Schedule Overview sheet to review sample collection schedules, schedule assignments, and active schedules.

The sheet includes:

• Schedule Metrics provides study, cohort, sample type, and subject schedule counts.
• Subjects with Active Schedules by Cohort and Subjects with Active Schedules by Sample Type provide visual summaries of active schedules.
• Active Schedule Summary provides summary schedule information.
• Collection Schedules provides collection schedule details.
• Schedule Assignments provides schedule assignment details.
• Active Schedules provides active schedule details.

Missing or Delayed Samples

Use the Missing or Delayed Samples sheet to identify collected samples that have remained at a location or in transit beyond a specified number of days.

• Enter thresholds in Days At Site Limit, Days In Transit Limit, and Days At Lab Limit. The sheet calculates the number of days since collection, shipment, or receipt and compares the results with the applicable threshold.
• Samples that exceed the applicable threshold display in red. Samples within the threshold display in green.
• Use the drop-down to select Show All Samples or Show Delayed Samples.
• Use the tabbed tables and charts to review Samples At Site, Samples In Transit, and Samples At Lab.
• The Derived Sample Histories table provides additional sample-level details.

Reconciler Results

Use the Reconciler Results sheet to compare Raw Sample Data with Derived Sample Histories after manifest reconciliation.

• In the Raw Sample Data table, use the Reconciler Fields column to view the fields used to reconcile each record.

Unreconciled Samples

Use the Unreconciled Samples sheet to compare unmatched collected samples from different sources and identify why they did not reconcile.

Select a Comparison and Sample Type to display results.

Study, Subject, Sample Type, and Aliquot are always used for reconciliation. Highlighted fields indicate additional reconciliation criteria.

Data Anomalies

Use the Data Anomalies sheet to investigate potential issues in sample and subject data. Highlighted cells indicate potential issues based on anomaly detection rules.

• In the Derived Sample History Issues table, the # of Samples column is highlighted when the value is not equal to 1.
• Data is identified as anomalous when:
  • Sample Location Type is missing
  • Sample processed but Received Date is missing
  • Sample Location is missing
  • Sample stored but Received Date is missing
  • Sample Type is missing
  • Sample processed but also shipped
  • Visit is missing
  • Sample stored but also shipped
  • Sample ID is missing
  • Sample not shipped but Shipped Date is provided
  • Accession ID is missing
  • Received Date precedes Collection Date
  • Sample Collection Y/N is Yes but Collection Date is missing
  • Shipped Date precedes Collection Date
  • Sample Collection Y/N is No but Collection Date is provided
  • Shipped Date precedes Received Date
  • Sample shipped but Received Date is missing

Note: Anomaly detection rules are customizable. Contact eClinical Solutions Support to update or remove the default rules or create additional rules. Configured conditions display in the Possible Issues column in the applicable tables.

Sample Overview Report Builder

Use the Sample Overview Report Builder sheet to create configurable reports of sample locations and expected versus collected samples by site, subject, visit, time point, and aliquot.

• Use the Display Sites, Display Subjects, Display Visits, and Display Aliquot drop-downs to configure the report. Yes is selected by default.
• Use the Display Time Points drop-down to select a time point display option. Yes - All is selected by default.
• In Locations of Samples by Site and Subject, a yellow Multiple cell displays when more than one sample is recorded in a cell based on the selected configuration.
• Expected vs Collected Samples by Site and Subject displays only when Collection Schedules are provided.
  • Cells in the Expected and Collected columns are highlighted when the values do not match, helping identify missing, delayed, or unexpected sample activity.

Sample Details Report Builder

Use the Sample Details Report Builder sheet to create configurable reports of sample details.

• Use the Display Sites, Display Subjects, Display Visits, and Display Aliquot drop-downs to configure the report. Yes is selected by default.
• Use the Display Time Points drop-down to select a time point display option. Yes - All is selected by default.
• In the Sample Details by Site and Subject table:
  • The Expected and Collected cells are highlighted when their values differ, helping identify missing, unexpected, or delayed sample activity.
  • The In Storage metric displays the number of samples where InStorageYN = Y*, indicating samples that are currently in storage.

Application Information

Use the Application Information sheet to view release highlights for the current SMA version, data refresh information by domain, a glossary of SMA terms, descriptions of available sheets, application version details, a link to SDTM Standards, and eClinical Solutions Support contact information.