Overview

Life Science Analytics Cloud (LSAC) is the leading AI-powered clinical analytics platform from Saama that seamlessly integrates clinical trial data, delivering more actionable insights for faster decision making. 

Saama’s suite of cloud-based applications in LSAC offer powerful data aggregation, monitoring, analytics, and collaboration capabilities, so sponsors and CROs can optimize study planning, enrollment, compliance, productivity, and oversight.

This document contains important information on new features and updates for LSAC v4.2.

New Features/Enhancements

This section gives a list of new features and/or updates for each module worked upon or improved.

Acronyms & Definitions

TermDefinition
CI
Clinical Insights
OIOperations Insights
SCESmart Clinical Explorer dashboard in CI insights
CMConcomitant Medication
AEAdverse Event
KPIKey Performance Indicator
CDHClinical Data Hub
DaLIADeep Learning Intelligent Assistant
LSACLife Science Analytics Cloud
EDCElectronic Data Capture
IDPIdentity Provider

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Enhancements in Clinical Insights

COM-5528: Enhancements in Lab Spaghetti Plot – Absolute Value & Baseline Deviation dashboard


The Lab Spaghetti Plot – Absolute Value and Baseline Deviation has been enhanced to plot subject visit data against study days. Subject data can also be viewed for a specific visit.

Scheduled visits are shown as another legend key below the subject legend key. The visit names are clickable and appear next to each other. Clicking on one or more visit in the legend key displays the corresponding data markers for those selected visits. All data markers of a selected visit are marked with a unique color that is matched to the color of the visit in the legend key.

Unscheduled visit data cannot be identified in the legend key but will be plotted on the graph. The widget chart can be maximized for better focus.

The toggle key for switching between Visit Schedule and Study Days has been removed from both the dashboards.

The entire data legend key table can be removed from sight, by switching off the Show Legends toggle.


The following enhancements are part of the Smart Clinical Explorer (SCE) dashboard that can be accessed in Focus: Patient Profile and in Analytics: Smart Clinical Explorer from the Clinical Insights tab. Analytics on this dashboard are observed for a single study.

                             

COM-5343, COM-5477: New widgets in the new DM domain tab

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The following widgets have been added to the new Demographics (DM) domain tab that is part of the SCE dashboard. 

  • Subject Screened: This widget displays the count of screened subjects, based on filter selection, where the disposition date is not null. This widget can be added as a filter parameter.
  • Screen Failure: This widget displays the count of subjects that have failed screening based on filter selection. This widget can be added as a filter parameter. Reasons for screen failure are grouped by reason and can be accessed as a pop-up window through this widget. 
  • Total Subjects Withdrawn: This widget displays the count of subjects withdrawn based on filter selection. This widget can be added as a filter parameter.
  • Deaths: This widget displays the number of deaths based on filter selection. This widget can be added as a filter parameter.
  • Race: This widget is represented as a donut chart and displays the count & percentage of subjects for each race or for each group defined by common physical traits. This widget can be added as a filter parameter.
  • Gender: This widget is represented as a donut chart and displays the count & percentage of subjects for each race or for each group defined by common physical traits This widget can be added as a filter parameter.
  • Age: This widget is represented as a bubble chart and displays the count of subjects at every age. Hover over the bubble to see details.
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COM-5476: New widget Disposition Summary in DM domain tab

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This widget, as part of the Demographics domain tab, is represented as a bar chart and displays the count of subjects in each disposition category/event that are listed below. Hover over the bar to see more details.



  • Prescreened
  • Screened
  • Consented
  • Failed Screen
  • Enrolled
  • Randomized
  • Follow Up Agreed
  • Follow Up Not Agreed
  • Treatment Initiated
  • Treatment Not Initiated
  • Withdrawn
  • Discontinued Before Treatment
  • Discontinued After Treatment
  • Withdrawal of Consent
  • Completed
  • Not Evaluable
  • Evaluable




COM-5346: New widget Patient Story in DM domain tab

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This widget, as part of the Demographics (DM) domain tab, is represented as a chart that displays the subject IDs along the Y axis and their respective dosing, disposition, CM & AE events against Study Days that is denoted by the X axis.

The Relative Study Days for each of the events are calculated as follows:

  • Dosing: Dosing Date - Subject Start Date
  • Disposition: Disposition Date - Subject Start Date
  • Drug Response: Response Date - Subject Start Date
  • CM: CM Date - Subject Start Date
  • AE: AE Date - Subject Start Date

               Hover over each of the events, in the chart, to see more relevant details associated with that event.

            

COM-5368: Demographic Listing


This tabular listing, as part of the Demographics (DM) domain tab, is represented as a table that displays demographic details of every subject ID as well as their respective date of informed consent and the arm/cohort, of the study, the subject ID belongs to. The Maximize option enables the user to see an enlarged view of the listing. The columns, in the listing, can be sorted in ascending or descending order. The columns of this listing are as follows:


  • Country
  • Site ID
  • Subject ID
  • Arm Description
  • Age
  • Gender
  • Race
  • Ethnicity
  • Weight (in kilograms)
  • Height (in centimeters)
  • BMI (kg/m2)
  • Date of Informed Consent

                

COM-5369: Disposition Listing


This tabular listing, as part of the Demographics (DM) domain tab, is represented as a table that displays disposition event details of every subject ID as well as the arm/cohort, of the study, the subject ID belongs to. The Maximize option enables the user to see an enlarged view of the listing. The columns, in the listing, can be sorted in ascending or descending order. The columns of this listing are as follows:


  • Study Identifier
  • Site Identifier
  • Country
  • Subject Identifier
  • Arm Description
  • Disposition Term
  • Controlled Terminology for disposition term
  • Category
  • Visit Name
  • Planned Study Day of Visit
  • Start Date/Time of Disposition Event
  • Study Day of Start of Disposition Event

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COM-5663, COM-5664, COM-5665, COM-5667, COM-5685, COM-5686, COM-5668, COM-5673, COM-5687, COM-5674, COM-5675, COM-5676, COM-5677, COM-5678: New AE widgets that reveal AE Statistics


The following widgets have been added to the new Adverse Events (AE) domain tab that is part of the SCE dashboard. 

  • Subjects with AE: This widget displays the count of subjects with adverse events, based on filter selection. This widget can be added as a filter parameter.
  • SAE to AE Ratio: This widget displays the ratio of SAE to AE. This widget can be added as a filter parameter.
  • Treatment Emergent AEs: This widget displays the count of treatment emergent AEs as per the following formula:
    • Count of treatment emergent AEs = Count of AEs having AE start date between AE exposure start date and AE exposure end date.
    • This widget can be added as a filter parameter.
  • AESI (Adverse Event of Special Interest): This widget displays the count of adverse events of special interest. This widget can be added as a filter parameter.
  • Top SOC with Highest AEs: This widget displays the name of the system organ class that has the highest number of subjects. This widget can be added as a filter parameter.
  • Subjects with Serious Related AE: This widget displays the total count of subjects with serious adverse events. This widget can be added as a filter parameter.
  • Site with Highest Study Drug Related AEs: This widget displays the name of the site having the highest count of subjects with IP-related AEs. If two sites have the same count of subjects, then the site name that appears first in alphabetical order will be considered. This widget can be added as a filter parameter.
  • AE with Highest Count: The widget displays the name of the adverse events which has the most occurrences. If two AEs have the same number of occurrences, then the AE which comes first in alphabetical order will be displayed. This widget can be added as a filter parameter.
  • SAE with Highest Count: The widget displays the name of the serious adverse event which has the most occurrences. If two SAEs have the same number of occurrences, then the SAE which comes first in alphabetical order will be displayed. This widget can be added as a filter parameter.
  • Site with Highest SAE: This widget displays the name of the site which has the highest number of serious adverse events. This widget can be added as a filter parameter.
  • Related AE Causality: This widget displays the count of subjects with AE-related causality. This widget can be added as a filter parameter.
  • Serious AEs: This widget displays the total count of all serious AEs. 
  • Site with least subjects with AEs: This widget displays the site ID that has the least number of subjects with adverse events and also displays the count of subjects. If two sites have the least number of subjects, then the site ID that comes first in ascending order is displayed.
  • Ongoing AEs: This widget displays the count of adverse events that have a past/current start date but no end date as yet.

       

COM-5688: New widget - AE Time Series in AE Domain tab


Addition of the new widget - AE Time Series is presented as a line chart that plots the subject count against each AE day that is indicated on the X axis. Hover over the data markers to see the count of subjects for that specific AE day.


Relative Study Day for AE (AE Day) = AE Date - Subject Start Date


COM-5351: New widget - AE Subject Count in AE Domain tab


Addition of the new widget - AE Subject Count is presented as a tabular listing and as a bar chart that plots the count of randomized subjects against each AE preferred term that is indicated on the Y axis. The tabular listing displays the total count and percentage of randomized subjects against the System Organ Class (SOC) AE term. Clicking on the SOC AE term displays the categorized count of randomized subjects for each of the AE preferred terms that are part of the SOC AE term.


COM-5370, COM-5791: New listing - Adverse Event Listing 


Addition of the new listing – Adverse Event Listing is presented as a tabular structure where each record represents the AE relevant details of a single subject. The list of columns is listed below. One or more columns can be sorted in ascending or descending order. 


  • Country
  • Site Identifier
  • Subject Identifier
  • Gender
  • Age
  • System Organ Class
  • Preferred Term
  • Reported Name
  • AE Start Date
  • AE Start Day
  • AE End Date
  • Seriousness
  • Severity Grade
  • Outcome
  • Relationship Study Medication
  • Action Taken with Study
  • Treatment Emergent
  • AE of Special Interest (AESI)
  • CTCAE Grading
  • AE Term

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COM-5679, COM-5680, COM-5681, COM-5682, COM-5690, COM-5692, COM-5695, COM-5696, COM-5697, COM-5698, COM-5700: New CM widgets that reveal CM statistics


The following widgets have been added to the new Concomitant Medication (CM) domain tab that is part of the SCE dashboard. 

  • Total Count of Distinct CMs: This widget displays the total count of unique or distinct concomitant medications identified in their standard medication name in the selected study.
  • Total Count of Subjects with CMs: This widget displays the total count of subjects who have been administered concomitant medications in the selected study.
  • % of subjects with CM: This widget displays the total percentage of subjects who have been administered concomitant medications in the selected study.
  • CMs without Medical Indicators: This widget displays all concomitant medications that have been listed without their respective standard medication name.
  • CM with highest subjects: This widget displays the name of the concomitant medication that has the highest count of subjects in the selected study.
  • Average CM Count: This widget displays the average count of concomitant medications administered to each subject. The average CM count is calculated as:
    • Average CM count = Total concomitant medications administered/total count of subjects screened.
  • Site with highest subjects using CMs: This widget displays the site identifier of the site with the highest count of subjects who have been administered concomitant medications. It also displays the count of subjects.
  • Most Frequent CM Indications: This widget displays the name of the CM that has been reported most frequently and also displays the count of subjects associated with the specific CM (concomitant medication).
  • Count of subjects with ongoing CMs: This widget displays the count of subjects who are being administered concomitant medications as per the present date.
  • Count of Ongoing CMs: This widget displays the count of concomitant medications that are being administered as per the present date.
  • Site with highest CM Count: This widget displays the site identifier of the site with the highest number of concomitant medications administered. 

           

COM-5722: New CM widget – Concomitant Medication


The widget Concomitant Medication in the CM domain tab displays the count and percentage of subjects for every standard CM category. The categorized count & percentage of subjects for every CM name can be seen by clicking on the CM category dropdown.


The CM Category is the primary filter to sort the CM data. The CM name can be selected for the selected CM category.


COM-5371: New CM Listing – Concomitant Listing


Addition of the new listing – Concomitant Listing is presented as a tabular structure where each record represents the CM relevant details of a single subject. The list of columns is listed below. One or more columns can be sorted in ascending or descending order. 


  • Country
  • Site Identifier
  • Subject Identifier
  • Reported Name of drug, medication or therapy
  • Standardized medication name
  • Category of Medication
  • Subcategory for Medication
  • Indication
  • Dose per Administration
  • Dose Description
  • Dose Units
  • Dosing Frequency per interval
  • Route of Administration
  • Start Date of Medication
  • Start Day of Medication
  • End Date of Medication
  • End Day of Medication
  • Duration of Medication



COM-6054: USDM Refresh Date and Time


The time and date of the Unified Study Data Model (USDM) refresh will be visible at the top right corner of all Operations Insights dashboards. The data and time will have a color code against it, to indicate the time elapsed since the last data refresh. More details can be obtained by hovering over the Info icon next to the USDM timestamp.

The USDM appears as a clock icon, next to the Analytics box, in the SCE dashboard. Hover over the clock icon to know the most recent USDM refresh date and time.


COM-6249, COM-5660: SCE Dashboard supports single-study analysis


The Smart Clinical Explorer (SCE) dashboard has been designed to display clinical analytics for a single study, at a time, which is selected from the Master Study Filter (MSF). All the domains, namely, AE, DM, and CM, respond to a single study for results.


The SCE dashboard is the default dashboard seen when the user navigates to the Clinical Insights tab from the Platform Left Navigation Bar.


COM-5139, COM-5846, COM-5141: New filter story bar in SCE dashboard


A new filter pane has been introduced at the top of the SCE dashboard. This filter story bar is populated when data points are selected from the several widgets that are part of the multiple domain tabs, namely, AE, CM, and DM in SCE dashboard. 


The filter selections are applied, by clicking the Apply button, and the resultant data is rendered on all SCE domains, namely, DM, AE, and CM. All filter selections can be cleared by clicking the Clear button.


Note: Data is rendered if all filter selections hold “True” or if all filter selections when combined in an ‘AND’ operation have values.


The filter pane or the filter story bar is indicated with a filter icon, which appears at the end of the filter box, and clicking on this icon can hide or unhide the filter story bar.


COM-5311: New dashboard filters - Country, Site, Cohort


Base filters, namely, Country, Site, and Cohort have been added to the SCE dashboard in all domain tabs. The user can select one or more values from these filters. Data in all widgets and listings, in all the domain tabs, is rendered as per the selections in these filters that are applied from any of the domain tabs.


The filters work in an ‘AND’ operation which means that data is rendered if all the selected values hold ‘True’ for the selected study.


COM-5322: Addition of GPP filter in SCE dashboard


The GPP filter is seen on the right pane of the SCE dashboard. One or more subject IDs can be selected, by selecting the check boxes, to be part of the filter pane or filter story bar. When the selections are applied, the widgets and listings will render data to reflect relevant details of the selected subject IDs in all the domains.


Clicking Select All will either select or deselect all the subject IDs. Click Apply to apply the selected filter values. 


To remove one or more subject IDs that have been applied, select and then unselect the checkboxes against them, and then click Apply. You can also click Clear to reset the filter selections.


Clicking on a subject ID will direct the user to the Graphical Patient Profile (GPP) of that subject. 


The list of subject IDs in the GPP pane is lazy loaded so as the user scrolls down the list, more subject IDs are loaded in the list.


COM-5660, COM-5661: Multiple Clinical Domains in SCE dashboard


The SCE dashboard is divided into tab, where each tab represents a specific domain area of clinical analytics. The domain tabs are Demographics (DM), Adverse Events (AE), and Concomitant Medications (CM). 


Filter values selected and applied in any one domain are applied in all the other domains, simultaneously. The user can extend the filter selections by moving to another domain and selecting more filter values and then applying them.


The default tab seen, when the SCE dashboard is loaded, is the Demographics (DM) tab. 


 The sequence of Analytics listed in the Clinical Insights focus are:

  • Smart Clinical Explorer
  • Graphical Patient Profile
  • Subject Event Log
  • Subject Progression
  • Lab Spaghetti Plot - Absolute Value
  • Lab Spaghetti Plot - Baseline Deviation
  • Concomitant Medications - Listing
  • Lab - Listing

  

COM-6012: Addition of New Columns in USDM Tables


The following columns have been added to the listed USDM table. These are:

  • Table: CM - Concomitant Medications
    • cmatctxt1: ATC Level 1 
    • cmatctxt2: ATC Level 2
    • cmatctxt3: ATC Level 3


Enhancements in Operations Insights

COM-5448: USDM Refresh Timestamp on all OOTB dashboards


The USDM (Unified Study Data Model) data refresh timestamp is captured on all OOTB dashboards and records the most recent successful runtime of the CQS adapter. For OOTB dashboards that render data for multiple studies at one time, the timestamp is visible for each study. The timestamp is displayed in the format of DD-MMM-YYYY HH:MM:SS. The list of dashboards where timestamp is visible are:

  • Portfolio Summary - Portfolio
  • Study Summary - Study
  • Site Activation - Study
  • Enrollment - Study
  • Quality Measures - Study
  • Subject Progression - Patient Profile
  • Graphical Patient Profile - Patient Profile
  • Lab Spaghetti Plot - Absolute Value
  • Lab Spaghetti Plot - Baseline Deviation
  • Safety Summary - Study
  • Data Metrics - Study
  • Cross Study Performance - Site
  • Adverse Events - Toxicity Profile
  • Site Summary - Site

A color-code next to the timestamp indicates the time period elapsed since the most recent data refresh. The color-code represents: 

  • Green - Within 24 hours
  • Yellow - More than 24 hours and less than 36 hours
  • Orange - More than 36 hours and less than 48 hours
  • Red - More than 48 hours

   

COM-3104, COM-6042: Addition of two widgets  - i) Subject Withdrawal by Reasons, and ii) Subject by Treatment Arm


The Enrollment dashboard has been enhanced to add two new widgets, namely,  

  1. Subject Withdrawal by Reason - This widget is represented as a donut chart, at study level and as a bar chart, at site and country level, and gives the count of subjects under each withdrawal category for a selected study, country and site. One or more countries and sites can be selected. Click on any category in the data legend to add or eliminate its visibility.
  2. Subject by Treatment Arm - This widget is represented as a bar chart and gives the monthly actual count of subjects in every treatment arm, starting from the study start date, in the selected study and in the selected site. This widget has 2 views, namely,
    1. Study - The count of subjects in every arm of the study is marked on the Y-axis against the monthly timeline, starting from the study start date till present.
    2. Site - Select one site to see the count of subjects is displayed as a bar in every treatment arm present for the selected date. Sites with no data present are greyed out and the site list is sorted alphanumerically to display the first site with 'Active' status in sorting order.
Note: If no treatment arm/cohort is present for a study, then the following message is displayed: Arm/Cohort level data is not available to render this widget.


COM-5132, COM-5131: Widget-'Site Activation and Enrollment Over Time' in 2 Analytics


The Site Activation and Enrollment Over Time widget, in the Site Activation dashboard, has been enhanced to show the monthly and cumulative count of subjects for the site and enrollment metrics in a selected study. The metric progress can also be seen for a user-specified time period or for the last 1, 3, 6, and 12 months. 


This widget has been added to the Enrollment Dashboard – Study with the same functionality.


The metric progress is assessed by the count of subjects achieved every month and cumulatively. The metrics are shown in bar and line charts as follows:


By Month View

  • Actual Enrollment
  • Planned Enrollment Count
  • Actual Site Activation Count
  • Planned Site Activation Count
  • Planned Site Activation milestone+

                 By Cumulative View

  • Cumulative Actual Enrollment
  • Cumulative Site Activated
  • Projected Enrollment Cumulative (Most likely forecast)
  • Planned Site Activation milestone+

          

+The metric Planned Site Activation milestone is represented as a bar with an asterisk on top (of the bar) and is present in both the Monthly as well as the Cumulative views. Different gradients/percentage of the planned site activation milestone, namely, 25%, 50%, 75%, 100% are visible in the graph at different points in time.

            

Note: The widget Site Activation and Enrollment Over Time has been added as a new widget to the Enrollment dashboard - Study.

        

COM-5135, COM-5888: New Site Activation Listing


The prior widget Site Activation by Country has been replaced by the Site Activation Listing table. The Site Activation Listing is a tabular structure where every record lists out the progress of metrics on every participating site in the selected study. The columns are listed as follows:


  • Site Name
  • Site Identifier
  • Site Country
  • Site Region
  • Site Creation Date
  • Site Planned Activation Date
  • Site Activation Date
  • Site Deactivation Date
  • Site Status
  • Count of Subjects Enrolled till Date
  • Count of Subjects Screened till Date
  • Count of Subjects Screened Failed till Date
  • Site Enrollment Status
  • Site Investigator Name


               

   

These columns contain search boxes in which one or more parameters/values can be specified and applied to render data in the Site Activation Listing accordingly. The filter values work in an 'AND' operation, so records are displayed for which all the filter values hold 'True'. 


The columns in the Site Activation Listing table, on the Site Activation dashboard - Study, can be sorted in ascending or descending order. The first three columns are 'freezed' by default, hence these remain constant as the user scrolls to the right. 

One or more columns can be selected for freeze/unfreeze and one or more columns can be selected to hide/unhide from the Settings icon that appears at the top right corner of the table.

The records of the Site Activation Listing table can be downloaded as a *.csv file.


COM-5184: New Widget - Site Activation Status


The Site Activation Status widget chart gives the count of sites in each of the categories, namely, Yet to Activate and Total Sites Activated in a selected study.


Clicking on the count of activated sites, directs the user to the Site Activation Listing table to see the prioritized list of the activated sites along with more details of each site.


The bar chart in the Country view, displays the count of activated sites in each of the participating countries. The user can select one or more countries from the Countries filter to get a more focused view of the bar chart. 


Clicking on the count of sites that appears at the top of the bar, directs the user to the Site Activation Listing table where the user can see records of the specific sites along with their respective details.


COM-5898: Enhanced Widget - Milestone Cycle Time


The Milestone Cycle Time widget, in Site Activation dashboard – Study, has been enhanced to display the site milestones achieved from three different views –

  1. Site - See the milestone cycle time of achieved milestones in all participating site. Select one or more sites from the Site filter to see a more focused view.
  2. Country - See the milestone cycle time of achieved milestones in all participating country. Select one or more countries from the Country filter to see a more focused view.
  3. Cohort - See the milestone cycle time of achieved milestones in all the cohorts/arms of the selected study. Select one or more cohorts from the Cohort filter to see a more focused view.

Lastly, the Milestone filter is a single-select, non-mandatory filter and can be seen in all the three views that are mentioned above. Only milestones that can be mapped to their next phase are listed in the Milestone filter. Selecting a milestone in the first search box determines the selection in the second search box of the Milestone filter.


The Site, Country, Cohort and Milestone filter are interdependent. The filter dependency logistics are explained below:

  • If site or country is selected and there are no milestones selected, then the widget chart displays all milestones available in the selected countries/sites.
  • If site/country is selected and the Milestone (From-To) filter is selected, then the widget chart will display the selected milestone cycle time if that milestone is available for the selected country/site.
  • If site/country is reselected but the milestone (From-To) selection has not changed, then the widget will render data based on the availability of that milestone for the selected site/country.
  • If a site/country is selected and then the milestone (From-To) filter is selected, then the sites/countries that have that milestone achieved should only be available for selection, else the sites/countries should be greyed.
  • If the Milestone filter is cleared and the Site or Country filter is not cleared, then the widget chart will display all milestone data that is mapped and ‘True’ for the selected sites/countries.

    

COM-5174: Addition of the Site Enrollment Status widget


The Site Enrollment Status has been added to the Enrollment dashboard – Study and is represented as a donut chart that gives the count of sites in the following two categories, namely, Active – Yet to Enroll, and ii) Active – Enrolling. 


Hover over one of the segments in the donut chart and click to be directed to the Site Activation Listing report to see all sites with the selected status marked in the selected study.


COM-5187: Enhancement to the Enrollment Funnel


The Enrollment Funnel in Enrollment dashboard has been enhanced to show the count of subjects in multiple disposition categories for every participating site and country in the selected study and cohort/arm.


In Site view, select a single site from the Site filter, in the Chart view, to see the count of subjects for the disposition events that have occurred at that specific site. 


In Country view, select a single country from the Country filter, in the Chart view, to see the count of subjects for the disposition events that have occurred in that specific country. 


The Table view displays the selections from the Study, Site, and Country view in tabular format. One or more sites, countries can be selected as filter criteria to view data from. The users can drill down from study to country level data and from country to site level data in the tabular format visible under Table view.


The user can download a *.csv file of the tabular records.


COM-5191, COM-5854: New widget - Subject Status Tracker


The Subject Status Tracker widget in Enrollment dashboard – Study, tracks every subject as he/she moves through the disposition events and various visits across different treatment arms as part of the clinical trial. The tabular listing contains details of every subject in the selected study. The tabular listings give the study-site-cohort details of the subject, consent-randomized details, visit-dosing-follow-up details and current status of the subject. 


All scheduled visits of every subject are captured. For visits:

  • If there is no scheduled visit planned, then the visit cell is blank.
  • If the expected visit date for a subject is a past date, then the visit date is orange in color.
  • If the expected visit date for a subject is a future date, then the visit cell is blue in color.

    

By default, the data in the Subject Status Tracker widget table is rendered as per the selection in the Study and Cohort dashboard filters. The selected Study Name and Study ID is visible above the columns.


Every column in the Subject Status Tracker table has a search box that acts as a filter to select one or more values. The search boxes of the columns Subject ID, Site ID, and Current Status are multi-select widget-level filters where the user can select one or more values in each column and the records are displayed if all the selected filter values hold 'True' together. Values from other columns can also be applied to the filtering process.


Columns can be sorted in ascending or descending order. The user can freeze/unfreeze and hide/unhide columns. 


The records of the widget table can be downloaded as a *.csv file with the Study Name and Study ID present. 


COM-4800: Addition of Cohort filter to OOTB dashboards


The Cohort filter is a single-select, non-mandatory dashboard filter that enables the user to select an arm/cohort, of the study, to achieve better focus on data. Data is rendered, in some widgets, based on the selection of this filter.  This filter is present in the following OOTB dashboards:

                
                Enrollment Dashboard - Study

Infographics

  • Subject Screened Count
  • Subject Screen Failed Count
  • % Subject Enrollment to Date
  • Planned Total Enrollment Count
  • Planned to Date Enrollment Count
  • Actual Enrollment Count
  • First Subject Enrolled: Days Delay Count
  • First Subject Enrolled: Planned Date
  • First Subject Enrolled: Projected Date
  • First Subject Enrolled: Actual Date
  • Last Subject Enrolled: Days Delay Count
  • Last Subject Enrolled: Planned Date
  • Last Subject Enrolled: Projected Date
  • Last Subject Enrolled: Actual Date

Widget – Enrollment Funnel

Disposition Event Counts

Widget – Total Enrollment (Country|Site)

Enrollment Counts (Planned|Actual)

Widget – Subject Screen Failure by Reason

Screen Failure Counts

Widget – Subject Count by Withdrawal Reason (Study|Country|Site)

Subject Withdrawal Counts

Widget – Site Activation & Enrollment Over Time

  • Enrollment Count (Planned|Actual)
  • Enrollment Count (Monthly|Cumulative)

Widget – Subject by Treatment ARM (Study|Site)

Enrollment Count for the selected cohort

Listing – Subject Status Tracker (Study|Site)

Subject Level Listing


                Safety Summary dashboard - Study

                

Infographics

  • Serious AE Rate per Subject Days
  • Non-Serious AE Rate per Subject Days
  • Total Serious AE Count
  • Total Non-Serious AE Count
  • Subject Enrollment Count

Widget – AE/SAE Trend (Time|Month|Site|Study Days)

AE Counts

Widget – Adverse Events by Body System

AE Counts

Widget – Adverse Events by Country

AE Counts


                Data Metrics dashboard - Study

                    

Infographics

  • %Data Point Completion
  • Average Days to Data Entry
  • %SDV Completion
  • %Primary Endpoint Data Completion
  • Data Entry Rate

Widget – Data Points Completion (Country|Site|Visit|Month)

  • Data Points Required
  • Data Points Entered

Widget – Avg Time between Data Collection & Entry in Days (Country|Site|Month)

 Average Time between Data Collection & Entry in Days

Widget – %SDV Completion (Country|Site|Visit|Month)

  • Data Points SDV Required
  • Data Points SDVed

Widget - %Primary Endpoint Completion (Country|Site|Visit)

  •  Primary Endpoint Required
  • Primary Endpoint Entered


                Quality Measures dashboard - Study

                            

Infographics

  • PD Rate
  • Threshold
  • Total PD Counts
  • Total Subject Days
  • Average Protocol Deviations per Subject
  • Average Protocol Deviations per Visit
  • Average Protocol Deviations per Form

Widget – Protocol Deviations by Category

PD Counts

Widget – Protocol Deviations (Year|Month|Country|Site|Visit)

PD Counts and Cumulative Enrollment Counts in Year and Month view


                Site Activation dashboard - Study


Infographics

  • Days to First Patient In (FPI)

Widget – Site Activation and Enrollment Over Time

  • Enrollment Count (Planned|Actual)
  • Enrollment Count (Monthly|Cumulative)

Widget – Milestone Cycle Time (Cohort)

Milestone cycle time for the selected Cohort


               

COM-4282: Harmonizing Logic for KPI


The calculation logic for the Disposition KPI - Screened Count has been corrected and is now consistent across the different modules (Legacy OOB dashboards, KPI Studio Reports, Oversight Scorecard) of the LSAC application. 


COM-5917: Recognizing Data Unavailability


The selection of values in the filters present as part of the different widgets has been enhanced to grey out the values/parameters where no data is present for analysis, so that these values are not available for selection. Refer to the table below to recognize the filters that have been enhanced for the widgets listed below.


DashboardWidget NameWidget Level Filters
Site Activation - StudyMilestone Cycle Time
View by: Site | Country | Cohort
Site | Country | Cohort
Enrollment - StudySubject Withdrawal by ReasonCountry | Site


Enhancements in Smart Search Powered by DaLIA*


COM-5354: Smart Suggestions from DaLIA


DaLIA increases the potential to make insightful decisions based on suggestions generated using AI, ML which is much time savior as it speeds up the data analysis by 60-70 percent for medical monitors.


Methods used for suggestions


  1. Pattern recognition: The objective here is to identify and capture succinct unique patterns in clinical data and to be able to detect risk factors in the early phases of study. To analyze and extract meaningful information from complex clinical data, a powerful computing tool is necessary. ‘K-means clustering’ is a proving technique to identify such patterns.
  2. Correlation Analysis framework: Clinical data contains many correlations which might not be visible through the human eye, but some disposition events are highly correlated within the clinical data itself and these are unnoticeable by medical monitors, and it costs most of their time to identify the root of study failures.


COM-5865: Integration of Suggestions window with CIO dashboards


The Smart Suggestion window will be placed at the bottom right corner of the CIO dashboard and when the user selects it, it will show suggestions. As of now, DaLIA smart suggestions will appear in the SCE dashboard and will be visible across all the domain tabs. The suggestions will be associated with the AE clinical domain.


The DaLIA suggestions has its own filter context. When the user clicks on the suggestion, he/she is directed to the dashboard and the filter context of the suggestion is applied on the dashboard without overriding the applied filters in the dashboard.


COM-5325, COM-5326, COM-5339, COM-5340, COM-5426: Scope & Calculations of New Intents - Combining Multiple Similar Intents


TypeIntentCalculationEntity
Site Activation (Handling multiple intents in one query)Count:
Planned sites and actual sites for study/site/country/region in Year/Month
Planned Site Count is present at study level only.

Only count is available for Planned Sites and there is no listing available.

Site Level:

Planned Site Activation Time (Planned Site Activation Date - (Site Selection Date (Actual Date))

Actual Site Activation Time: Actual Site Activation Date -(Site Selection Date (Actual Date))

Country Level:

Mean (Average) of site activation times from all the sites present in that country.

Region Level:

Mean (Average) of site activation times from all the sites present in that region.

Study Level:

Mean (Average) of site activation time from all the sites present in that study

Note: Sites with Site Activation Tie = 0, are not considered while calculating average site activation time at country and study level.
Study, Region, Country, and Site
Site Issues (Handling multiple intents in one query)Listing & Count of one or more site issue status combined with and/or/not/but operatorsCount of site issues based on criteria in user queryStudy, Region, Country, and Site
Protocol Deviations (Handling multiple intents in one query)Listing & Count of one or more protocol deviation status combined with and/or/not/but operatorsCount of PDs based on criteria in user queryStudy, Region, Country, Site
Query Resolution (Handling multiple intents in one query)Listing & Count of one or more query resolution status combined with and/or/not/but operatorsCount of queries based on criteria in user queryStudy, Country, Region, Site
Disposition Events - Screened & Enrolled (Handling multiple intents in one query)Listing & Count of one or more disposition events, namely, Screened & Enrolled combined with and/or/not/but operatorsCount of Disposition EventsStudy, Region, Country, Site

*DaLIA’s responses or answers-to-queries are determined by the data present in the USDM (Unified Standard Data Model) and by the underlying data that is processed to draw out the various OOB KPI analytics. DaLIA is not trained to respond to any query based on custom configurations or to any query based on the OOB KPI Studio reports; response to such a query will be inaccurate or null.


Enhancements in LSAC Platform Applications


LSPT-1438: SSO Login option for LSAC user


When adding a user, the LSAC admin can choose to enable SSO by switching On (enabling) the SSO toggle switch directly from the Add User screen in User Management module.


This will allow the newly registered user to bypass the mandatory Saama LSAC IDP settings and will direct the user to the client’s IDP mechanism after the user enters the username when logging into LSAC.


This SSO-enabled user will have to enter only the following details at the time of setting up his/her user account in LSAC. These details are-i) First name, ii) Last name, iii) Accept Terms and conditions. Password credentials/ MFA settings will not be required for this user.


If the SSO flag is disabled for a user, then the new user registration will include all the following details – i) First Name, ii) Last Name, iii) Accept Terms and Conditions, iv) Setting up Password, v) MFA. The MFA step will require the user to verify his/her credentials through an email verification sent on the registered email address.


By default, the SSO toggle key is disabled or set to Off.


Note: The SSO option can also be enabled or disabled at a user-level irrespective of the LSAC account settings. This is done to allow the LSAC admin flexibility while setting up users.


LSPT-1407: Remember Me feature


At the time of logging in, into the LSAC application, the user can select the Remember Me check box so that he/she does not have to enter the username on consecutive login attempts. As the user attempts to enter the username, he/she will be prompted to select the username from the dropdown box.


If the browser window is accidentally closed (without logging out of the LSAC application), and opened again, the user will not be required to login. At the same time, if the user logs out of the LSAC application, and then closes the browser, he/she would have to re-login.


Unchecking or not selecting the Remember Me check box will require the user to enter his username each time he/she logs in.


Clearing all browser cookies will require the user to select the Remember Me check box again at the next login so that he/she does not have to enter the username.


LSPT-1406: Tracking MarketPlace module usage through Pendo


The MarketPlace module has been integrated with Pendo, on the client Preview and Production environments, to track the usage statistics of the module including other KPIs of the module for improvisation purposes. 


All usage statistics collected from MarketPlace module are seen in the Pendo application. No visible changes are seen on the MarketPlace UI.


LSPT-1211: Use of Cookies


The Cookie Policy popup appears at the bottom left corner of the screen when the user logs in. The cookie popup raises awareness of the use of cookies and stays on the screen till the user clicks OK to accept the use of cookies and agree to the terms and conditions thus.


The user can click on Privacy Policy, before clicking OK, to read the terms and conditions on the usage of cookies. Clicking on Privacy Policy, directs the user to a new browser tab where he/she can read about the policy in detail.


Once the user accepts the cookie policy, the pop-up will not be visible till the next 90 days.


The LSAC application captures cookies, from time to time, and seeks the consent of the user to its usage to drive better customer experience. 


LSPT-1192: Email Verification to support MFA


The multi-factor authentication process is supported with an email verification step where the user receives a system-generated email, after entering his/her username and password on the LSAC login screen and is then required to enter the one-time password (code) received on the registered email ID (username) to complete the login process.  

  • Each OTP is valid for 3 minutes.
  • 6 wrong attempts at entering the OTP will lock the user's account
  • In case of any unforeseen network issues, the user has the option to Resend OTP, after 30 seconds, to the registered email address (username).

                All the above scenarios only apply for users whose LSAC client account is


LSPT-816: LSAC Application version is visible


The version number of the deployed LSAC application will be visible to all users once they login into the application and navigate to the admin applications. 


The user can click on the face icon, which appears at the top right corner of the screen, to see the LSAC application version in the dropdown. 


This versioning captured in the application, will help the LSAC admin, support and technical teams to identify the version of code deployed and will help them to run a quick check on other technical activities that will drive better performance and user experience.  

    

LSPT-734: Common App Level Error pages for LSAC Apps


The access to the LSAC applications is based on the access defined for every user. A user may have access to one or more LSAC applications. In a bid to have a common unified UI and theming across all integrated LSAC applications like Analytics, CDH, etc. Common Error pages are introduced in this release.


A user can encounter error pages due to multiple reasons, such as, session timeout, infinite redirects, accessing an application the user does not have access to and so on. The error messages are represented by commonly used industry standard codes such as 404, 405, and so on.


For this release, common error pages have been integrated in the following modules:

  • MarketPlace
  • Authorization (Platform)


Moving ahead, common error messages will also be applied to other LSAC applications, such as, Analytics, CDH, and so on. 


LSPT-447: Addition of MFA Registration in LSAC


The process of user registration is now concise, crisp and less time consuming. A new user account can be registered in any 4 ways to the LSAC application. These are:


            

Configuration Settings (Account & User level)New User Registration Steps (Sign Up Process)

LSAC Account is MFA Enabled, SSO option is Disabled at the User level

MFA = On (Account), SSO = Off (User)

  • First Name, Last Name
  • Password
  • Terms & Conditions
  • One-Time Password

LSAC Account is MFA Disabled, SSO option is Enabled at the User level

MFA = On (Account), SSO = On (User)

  • First Name, Last Name
  • Terms & Conditions

Note: The SSO selection supercedes the MFA selection.

LSAC Account is MFA Disabled, SSO option is Disabled at the User level

MFA = Off (Account), SSO = Off (User)

  • First Name, Last Name
  • Password
  • Terms & Conditions

LSAC Account is MFA Disabled, SSO option is Enabled at the User Level

MFA = Off (Account), SSO = On (User)

  • First Name, Last Name
  • Terms & Conditions

Note: By default, registration for a new user will be MFA-enabled and hence will be a 2-step process. MFA solution can be disabled at an account-level from the backend. If MFA is disabled for a client account, then all users that are part of the account will require only a 1-step process to register and if the MFA is enabled for a client account, then all users are required to register to the LSAC application with a 2-step process.


LSPT-1493: Email verification to complete MFA


An email verification is sent to the user, at the time of registration, through the MFA registration process to LSAC. The email is sent to the registered email address (username) of the user and he/she is required to complete the registration process by entering the one-time password (OTP) received in the email and then clicking Submit. 


Every LSAC user, for an MFA enabled account, will be required to enter OTP while logging in to the LSAC application every time. User will receive this OTP on his/her registered email address (username).


Every OTP received in email is valid for the next 3 minutes

In case you do not receive the email containing the OTP, you can click Resend OTP that will be active on the screen after 30 seconds. You can click Resend OTP after every 30 seconds provided you do not receive the email on your registered email address. Once you click on Resend OTP the previously received OTPs expires.


LSPT-1422: Moving users from SSO to non-SSO and vice-versa


Users with SSO registration can be moved to MFA registration and vice versa in the following ways:

  • An existing Non-SSO user is updated to SSO (flag is set as ON), then Saama LSAC should not prompt the user to enter the password and to enter the one-time password (OTP) while logging in. The same should be handled by the client account IDP mechanism.
  • An existing SSO user is updated to Non-SSO (SSO flag is set to OFF), then a system generated mail will be sent to this user prompting the user to setup his password and setup his multi factor authentication mechanism before logging in again.
  • If an existing LSAC account is migrated from a non-MFA solution to an MFA solution, then all the existing users (of that account) will be required to complete the email-OTP verification step.


    An email titled, "Update User Account" will be sent to all the respective users. Users can click Update User Account link to complete the email-OTP verification step. The email will be valid for the next 48 hours. To be able to successfully login into LSAC, the user will be required to complete the email-OTP verification step. Until this step is not completed, the status of the existing user will appear as Pending in LSAC User Management module.


    Note: If the user directly logs into LSAC without completing the email-OTP verification step, then he/she will be redirected to the OTP-setup process. 

  • For creating a new user through the SSO solution, the steps required to complete the user registration process:
    • Update User's profile (only name is required)
    • Accept Terms and Conditions
    • System generated emails are sent to the user that include - i) App Access email, ii) Account Access email, iii) Setting up LSAC User Account email
  • For creating a new user through the MFA solution, the following steps will complete the registration process:
    • Update user profile (name and password is required)
    • Accept Terms and Conditions
    • Prompt user to enter OTP
    • System generated emails are sent to the user that include - i) App Access email, ii) Account Access email, iii) Setting up LSAC User Account email


LSPT-1559: Email action to Update User Account 


When an existing user’s account is updated or modified, an email is sent to the user’s registered email address where the user is required to update his/her user account by clicking on the Update User Account link that is received in the email.


This link to update the user account is valid till the next 48 hours.


Possible scenarios when this email is triggered are:

  • When a user is switched from SSO solution to non-SSO solution
  • When an LSAC account is switched from non-MFA to MFA
  • Any other changes to a user's account

    

A single email on updating the account contains all the required steps to initiate the process and to see it to completion.


LSPT-1663: Configure SSO flag in Bulk User Upload


The bulk user upload feature allows the LSAC admin to upload an Excel file that creates multiple new users into the Users module of the LSAC application.


A new column, namely SSO, has been added to the Excel file to give the LSAC admin the ability to configure an SSO solution for every individual user by selecting On to enable the SSO solution or by selecting Off to disable the SSO solution.


The SSO column is non-mandatory and if no value (On/Off) is entered by the LSAC admin, then the user or the set of users are uploaded into the Users module with the SSO flag set to Off. There is no error message generated if the Excel file is uploaded with the SSO column as blank.


This user registration settings can also be modified, for every user, once all the users have been uploaded into the Users module.


LSPT-1693: Setup Email - LSAC Account Access


Once a new user is created into the LSAC account, he/she will receive an email confirming the name of the LSAC account that he/she has been added to.


LSPT-1694: Setup Email - LSAC Application Access


Based on the LSAC application access defined for the user at the time of user creation/modification, the user will receive an email confirming the applications/modules that he/she has been granted access to. Users will receive a single email containing the names of all the applications that the user has access to as opposed to receiving a separate email for every application access granted.


LSPT-1695: Setup Email - LSAC Account Activation


The new user will receive an email that contains the LSAC user account setup link to complete the registration/verification process on LSAC. The user account setup link will be valid for the next 48 hours. If the user is unable to register in the given time, the user account setup link will expire and the user has to reach out to the Admin to send a new user account setup email. 

 

Enhancements in Clinical Data Review - Tasks

LCDR-15, LCDR-28: Tasks creation on Data Markers & Legacy Dashboards 


Tasks can be created at a data point level in the Smart Clinical Explorer dashboard. The Task console pops up when the user right-clicks on any data point in the following widgets in the SCE dashboard.


The task console opens, right next to the widget that contains the data point. It is a floating popup and hence can be repositioned anywhere on the screen. The console can also be scrolled to add more inputs.


Full Task Console


When opened for the first time, the task console opens with all data fields ready for input. The title bar automatically captures the task metadata (created by combining the dashboard name, widget name and filter story). The user can fill in the description of the task along with other related task details and then submit it in the application. 


Mini Task Console


A mini task console opens when the user creates the next task in the same login session. The task console captures most inputs from the previously created task, such as task priority, names of assignees and observers, and so on, so that the user can focus on the task description and then submit it. 

Incase the user wants to see all the input fields or wants to see the full task console, he/she can click Customize Task or unselect the check box Cloned from previous task and then all data fields can be modified.


Note: For a legacy dashboard, a user can create or add a task by clicking on the Ellipsis icon, which appears in the top right corner of the dashboard, and then selecting Add Task.


LCDR-06: Viewing Tasks


The list of opened tasks can be viewed from any widget, in the SCE dashboard, by clicking on the Ellipsis menu, which appears at the top right corner of the widget and selecting View Tasks (N). N denotes the count of tasks that are open. 


The Tasks console opens where the user can see the list of all open tasks and can sort the list by Priority and/or by Modified On (displays tasks in most recent order of modification). Clicking on View Task, which appears with every listed task, directs the user to the Collaboration dashboard where he/she can click on the task ID to open the Task Details console and can view/edit the details of the task depending on the access defined for the user.

 

LCDR-24: Setting Task Priority


The user can choose from the following priority selections when creating a task from the Add Task console. These are:


Note: All tasks in the system prior to the LSACv4.2 release have been marked Urgent , in priority, if they were labelled as Urgent and Medium, in priority, if they were not labelled as Urgent. 

The period for task completion is automatically set to a date that is 15 days from the task creation date and this date can be modified.


The Add Task console contains the following data fields:


  • Title
  • Description
  • Task Type
  • Task State
  • Action
  • Priority
  • Due Date
  • Assignee
  • Observer
  • Email Notification
  • Extended Attributes (Expanded by default with ability to collapse)
  • Clinical Attributes (collapsed by default with ability to expand)



Note: The author (user who creates the task) and the user with edit access can change the task priority and other details when modifying the task from the Collaboration dashboard.


LCDR-15: Capturing Images on Task Creation


The Add Task console captures the image of the widget, as a screenshot, on which the task is being created in the SCE dashboard. For a task being created on other legacy dashboards, the Add Task console captures the screenshot of the dashboard.


The screenshot can be removed and can be added, if needed, by the user manually or can be captured again by the system. The label that appears below the image allows the reader to clearly distinguish between a system generated screenshot and a manually captured screenshot by labelling it as Automatically Captured with timestamp and Manually Captured with timestamp, respectively.


Note: Only one screenshot can be captured or added to a task. The screenshot captured cannot be modified when editing a task.


LCDR-27: Open Task Console without Reload


When a user right-click a widget and selects Add Task, a pop-up window opens next to the widget without reloading the dashboard page or without opening the Add Task console in a new browser window.


Similarly, when a task is created on any other legacy dashboard, the Add Task console opens instantly as a pop-up without reloading the dashboard page or without opening the Add Task console in a new browser window.


LCDR-33: Task State is Open


When a user adds or creates a new task, the state of the task is marked as Open and this label is visible as the first value in the Task State dropdown. If the dropdown does not display Open as the first value, then it should display the next value that appears in sequence in the Task State dropdown.


LCDR-34: Task ID Generation


Every new task is uniquely identified by a task ID that is assigned to the task once it is submitted in the application. The task ID is made up of the following parameters – i) Year of Task creation, ii) Month of Task creation, iii) Day of Task creation, iv) Timestamp of Task creation recorded in Hours, Minutes, Seconds, Milliseconds.


All existing task IDs in the application have been updated to align with the above format.


LCDR-35: Access to Tasks


The dropdown list of users/teams, that can be marked as assignees and observers, will contain only those users and teams who have access to the selected study. 


If a task being created is applicable to multiple studies, then only those users and teams are visible in the dropdown that have access to all the multiple studies listed. 


Observers can supervise a task and can only add comments to it without editing any other task data fields.


Tasks can be created or added by users who have Edit access to the Tasks module. Tasks can be viewed by users who have View access to the Tasks module.


Incase of auto-generated tasks, such as Monitor tasks that do not have any assignees or observers, the task will be automatically assigned to the user who created the Monitor with the statement that ‘No Assignee/Observer was found for this study’.


LCDR-36: Generating Task Titles


The title bar of the task that is being created/added is based on clinical attributes and captures the dashboard name, study name, site name, and subject ID in the task title automatically. Missing clinical attributes are not captured while maintaining the sequence of the task title.


A task title is editable and can be modified by the author (task creator).


For SCE dashboard, where tasks are created at a data point level, the following naming sequence is captured by the system when assigning a title to the task. This sequence is Study Name, Widget Name, Filter Story.


LCDR-40: Accessing Tasks from Collaboration Dashboard 


Existing tasks can be accessed from the Collaboration dashboard that is accessible from the Collaboration tab in the Left Platform Navigation bar.


Clicking on the task ID or on the Open symbol next to every task, opens the Task Details console, as an overlay on the Collaboration dashboard, where the user can see all the values in the task data fields. If the task is missing a screenshot, it will display No screenshot captured. Clicking on the screenshot will open an enlarged view of the image with the task title displayed on top.


Clicking on Live Report link, which appears at the top right corner of the Task Details console, will direct the user to the specific dashboard or widget (in case of the SCE dashboard), in real time keeping the Task Details console as an overlay, and display a dashboard view or a widget view that is aligned with the context or parameters on which the task was created. Clicking Go to Collaboration link, will direct the user back to the Collaboration dashboard.


Changes done to the task including changes to task metadata, by an authorized user, from the Collaboration dashboard will be carried forward when the user navigates to the task screen.


LCDR-16: Integration of CDR into CI dashboards


Task creation on the fly has been made possible by integrating various components of the CI dashboard with components of the CDR feature. The properties of the Task console and the placement of the same (especially on the SCE dashboard) has been kept in mind to drive a user-friendly and intuitive task integration experience.


Tasks can be created on all widgets and listings, in the SCE dashboard in Clinical Insights (CI), except on Summary Cards/Infographics and Graphical Patient Profile (GPP).


LCDR-169: About Task Emails


If the Email Notification toggle is enabled, when creating a task, then all the assignees, observers and the author of the task will receive an email the subject of which will contain the following information as: Task Priority (if it is marked Urgent), Task Created on timestamp, Task ID and Application Name.


The Task email body will contain the following information in sequence – i) Account, ii) Task Owner, iii) Task ID, iv) Due Date (dd-mmm-yyyy), v) Priority, vi) Task Title, vii) Task Description, viii) Task Type, ix) Task State, x) Assignees, xi) Observers (if any), xii) Comments, xiii) Extended Attributes (if any), xiv) Clinical Attributes (if any)


LCDR-67: Viewing Tasks in Task List console


Existing tasks can be viewed by clicking on the Ellipsis icon, which appears at the top right corner of CI widgets and listings, and then selecting View Tasks (N), where N denotes the count of open tasks. On the Task List console, the user can see each task summarized in a way to include the following components – i) Task ID, ii) Date Modified [dd-mmm-yyyy (hr:mm AM/PM)], iii) Task Title, iv) Assigned To, v) Task Description, vi) Priority, vii) Status


Sorting of tasks, in Task List console, can be done on the basis of – i) Priority, ii) Modified On, iii) Created by Me (from dropdown), iv) Assigned to Me, v) Observed by Me. The selection All in the dropdown will display all the tasks.


By default, tasks are sorted based on 2 parameters, namely, i) Assigned to Me, and ii) Modified On (in most recent order)


If the Task title is long and cannot be displayed in one line, then 3 dots appear in the Title bar and more details can be fetched when the user clicks on it. Similarly, to see more of the task description that may not be visible upfront, the user can click Show More and Show Less to collapse it.


Clicking on View Task, which appears next to each task summary, from the Task List console directs the user to the dashboard/widget view that is filtered to maintain the context of the task and its metadata.


LCDR-138: Viewing Tasks in Collaboration Dashboard


A user can view tasks that are associated with all the studies that the user has access to. Task view can be sorted to show tasks that are i) Assigned to Me, ii) Created by Me, iii) Observed by Me.
 By default, the sorting view selected is Assigned to Me.


If the user is not an assignee/not a creator/not an observer for a task that is associated with the study that the user has access to, then the user can only view the task and not edit it.


The task table in the Collaboration dashboard list each task as a record which has the following columns: 


  • Application (Indicated by color of application legend)
  • Starred
  • Task Title
  • Priority
  • Task Type
  • Updated
  • Due Date
  • Status
  • Action
  • Author
  • Assignee
  • Link to Open task

     


The Task ID value is a link that opens the Task Details console as an overlay in the Collaboration dashboard and so does the Open icon, once the user clicks on it.


The Open Tasks by Application displays the count of all tasks that are open in various modules of the application, such as, CI, OI, KPI Studio, based on the sorting view selected. By default, the count of open tasks is seen for all applications categorically.


The Task summary card at the top right corner, displays the count of tasks categorized as i) Overdue, ii) High Priority, iii) Starred, based on the sorting view and application category selected. One or more task status can be selected from the Task summary card.


The task table is divided into 2 tabs – i) Open Tasks (N), ii) Closed Tasks (N), where N denotes the integer count.


Tasks in open and closed tabs are seen based on the selections done in the sorting view (one selection), application category (one or more selections can be done), and task status selected (one or more selections can be done), where the Open Tasks tab lists all open tasks as per the prior selections done and the Closed Tasks tab lists all closed tasks as per the prior selections done.


 If, for a user, there are zero tasks in all the sorting views, namely, Assigned to Me, Observed by Me, and Created by Me, then the Open Tasks by Application tile will display the message, 


No task available for you at this time.


The Task summary card will display zero value in all the task status categories and the table will display the message, 


No records found.


Any task falls under an application, that is categorized as follows:

  • Clinical Insights – All tasks created manually from CI dashboards including SCE dashboard.
  • Operational Insights – All tasks created manually from Operations Insights.
  • RBQM – All auto-generated tasks created from Monitor within Analytics and KPI Monitors.
  • KPI Studio – All tasks created manually from KPI Studio
  • Clinical Data Review – All tasks created manually from Data Review window.
  • Others – Old manual tasks created from Task List (without any association with reports) + any other tasks that are not mapped to any of the above categories.


LCDR-178: Enable Email Notifications in Monitor Template


The Add Monitor template in Centralized Monitoring module has been modified to add the Send Email Notification toggle switch. This toggle switch has been added to the following OOTB monitors, that are:

  • Discontinuation Rate by Site
  • Open and Closed Query Aging Monitor
  • Protocol Deviations Rate by Site Monitor
  • Query Rate Monitor
  • Related AE by Site
  • SAE Rate by Site
  • SDV Monitor by Site
  • Subject Enrollment Rate Monitor
  • Subject Screen Failure Rate Monitor

The Add Monitor template in Centralized Monitoring module has been modified to add the Send Email Notification toggle switch. This toggle switch has been added to the following OOTB monitors, that are:

Enhancements in Clinical Data Hub (CDH)

PDA-6753: Extraction and Browsing of Operations Data


User with a role of Operations Admin will be able to view the Operations data for the layers ODL/CDM/USDM and will also be able to pull data from the layers ODL, CDM, and USDM with the help of web services.


PDA-6688: Metadata Changes are supported USDM Refresh Date and Time


System shall be able to support the constructive and the destructive metadata changes for the file-based operation pipeline data flow.


PDA-6754: Enable Metadata Pull


User with a role of Study Admin shall be able to view the metadata for the given EDC data set which are pulled from the Biostats adapters.


PDA-6828: Handling Special Characters in RAW data job


System shall be able to handle all the special characters in the column names. All the special characters shall be replaced by underscore.


PDA-6689: Support for Parquet, Orc, & Avro data formats


System shall be able to process data in the file formats Parquet, Orc and Avro by converting it into Excel format for file-based data processing.

Bug Fixes

    There are no fixed issues for this release.

Known Issues

    The known issues for this release are as follows:


JIRA IDBug Description
LSAC Analytics
COM-7074The 'Load More' button is not loading additional records in the Closed Tasks tab present in the Collaboration dashboard.
COM-7061Duplicate records are seen in the listing table in the Lab Spaghetti Plot - Absolute Value dashboard.
COM-7077The PDF export in Enrollment dashboard does not fetch the active tab in Enrollment Funnel and only prints the Study tab in Chart view. The Subject Status Tracker table is not seen in the PDF file.
COM-7066The Summary Cards, namely, % of Subjects CM and Average CM per subject are showing infinity value.
COM-7059The count of subjects withdrawn seen in Subjects Withdrawn and in Disposition Summary widget, in SCE dashboard, do not match
COM-7057Product logic needs to be updated for disposition events created before and after the study start date and the study end date respectively.
COM-7058There is a mismatch in Enrollment Count seen in Safety Summary and Enrollment dashboards.
COM-7042The logic for calculating percentage of disposition events seen in the Enrollment Funnel of the Enrollment dashboard - Study, needs to be updated.
COM-7025A modified query response is expected when user changes values in the filters captured by DaLIA.
COM-1765Spacing issues and alignment issues arise when the user navigates to the applications in MarketPlace module.
Clinical Data Hub
PDA-7117When RAW and SDTM data sources are present in the study, the Pre-Conformance layer is picking up data from the SDTM PDL schema instead of the RAW PDL schema. Conformance views are not created when the study has RAW and SDTM data sources.
PDA-7143Blinded Data Flow: When metadata is marked as Optional and the process real flag is set to 'No', the real files are being processed through the RAW job.

Technical Support

Customers can submit issues via our support portal (support.saama.com) or calling the support line (866) 619-9995 during normal business hours. For any other query customers can contact us on the email address: support@saama.com