For this release:
- The analytics tab, Clinical Insights (CI) has put focus on Oncology trials and has introduced a new tab in SCE dashboard for the same, along with some new listings and other key enhancements in GPP, CI dashboards.
- The analytics tab, Operations Insights (OI) has introduced a new portfolio management dashboard and a new subject visit compliance dashboard that gives key insights into visit compliance along with several key enhancements.
- Creation of Tasks, as part of the CDR, has been introduced on Tabular Analytics/Listings.
- There have been some minor but critical enhancements under the Administrative tab.
- There are new suggestions in Saama DaLIA along with some new combined AE intents.
The features/enhancements are categorized, as follows, for better understanding and assimilation.
Abbreviations & Acronyms
The list of applied acronyms and abbreviations is mentioned below:
|LSAC||Life Science Analytics Cloud|
|CDH||Clinical Data Hub|
|DaLIA||Deep Learning Intelligent Assistant|
|PDA/PDL||Patient Data Analytics/Patient Data Layer|
|OOB||Out of the Box|
|SSO||Single Sign On|
|MSF||Master Study Filter|
|KC||LSAC Key Cloak Server, that is, the Authentication Server that stores user information|
|ODL||Operation Data Layer|
|EDC||Electronic Data Capture|
|CDL/CDM||Common Data Layer/Common Data Model|
|CTMS||Clinical Trial Management System|
|PP||Patient Profile Focus area in application|
New Features/Enhancements in LSAC Analytics
New! Executive Summary dashboard - Portfolio
A new dashboard, namely, Executive Summary dashboard – Portfolio’ has been introduced in OI that facilitates visibility of overall performance of all studies that are part of the management portfolio. It comprises of primarily two tabs – i) Overview tab and the ii) Study tab.
The Overview tab of the Executive Summary dashboard is powered with three main sections that help the executives gain competent insights into portfolio performance and behavior. These sections are:
- Portfolio Summary - Drives insights into study distribution under various clinical perspectives.
- Portfolio Performance - Drives insights into study performance through clinical assessment governing study progress.
- Study Details Table - Drives insights into study milestones achieved and other metadata.
The Study tab has been introduced in the Executive Summary dashboard – Portfolio that renders comprehensive insights into the progress of a specific study indicative through milestones achieved, KPIs, and so on.
New! Subject Visit dashboard - Study
A new dashboard, namely, Subject Visit dashboard – Study’ has been introduced in OI that drives insights into the progress of the selected study of interest, by giving an account of every subject visit and its compliance status. An overall analysis of visits is possible by understanding the distribution of visits over participating sites and over scheduled visits, based on the stated visit compliance norms and the current protocol version being implemented.
A handy tool, the Subject Visit Tracker, provides a detailed analysis into the visit journey of every subject, from screening till the last disposition event, to include visit compliance details, such as, Missed Visits, Out-of-window visits, On-schedule visits.
Unscheduled visits are also recorded in the Subject Visit Tracker.
Enhancement! New column in Oversight Scorecard (Site View)
A new column, namely, LPLV (Last Patient Last Visit) has been added to the site-based view of Oversight Scorecard. The new column reading can be seen in the tooltip that appears over site name and can also be seen as one of the columns in the tabular view that presents details of all participating sites.
Enhancement! Withdrawal Rate Logic
The values in the two table fields: Withdrawn and Withdrawal of Consent are clubbed together to calculate Withdrawn % and Withdrawal Rate. Dashboards that are using the improvised calculation are:
- Portfolio Summary dashboard - Portfolio
- Site Summary dashboard - Site
- Site Cross Study Performance dashboard - Site
- Site Performance dashboard - Study
- Enrollment dashboard - Study
- Oversight Scorecard
Enhancement! Renamed - Subject by Treatment Arm widget
For ease of understanding and reading, the Subject by Treatment ARM widget has been renamed to Subject by Treatment Arm.
Enhancement! Legend key enhancement in Subject Status Tracker widget
The legend key of the Subject Status Tracker widget in the Enrollment Dashboard – Study has been enhanced to cover all visit details highlighted in the widget.
Enhancement! KPI Table in Site Performance - Study
The table showing the highest and lowest performing sites, based on the KPI selected, has been enhanced to show the column: Enrollment Count. A new instant search facility has also been added to the table to obtain quick results.
JIRA IDs that are applicable to the above stories in OI are: COM-8164, COM-8165, COM-8166, COM-8167, COM-8168, COM-8169, COM-8170, COM-8171, COM-4753, COM-6518, COM-6516, COM-6519, COM-6806, COM-5367, COM-8342, COM-8343, COM-8345, COM-8346, COM-8367, COM-7109, COM-7983, COM-8273, COM-8388, COM-8492, COM-8493, COM-8963, COM-8964, COM-8967, COM-8990, COM-8488
New! A new tab, Solid Tumors, has been added to SCE
The addition of the Solid Tumors tab in the SCE dashboard gives insights into various components of an oncology study. The Solid Tumors tab is divided into various components that allows users to assess certain metrics and fetch relevant details. These components are:
- Solid Tumors - Infographics - These provide a quick summary or overview on certain statistics associated with oncology, for a study of interest.
- Solid Tumors - Disease Response Assessment - This widget provides an insight into the response of every subject to the treatment that is measured over study days. The widget displays a separate chart for each cohort of the selected study. The charts can be expanded or collapsed for viewing flexibility.
- Solid Tumors - Change from Baseline SOD - This widget displays changes in % change from baseline SOD. It focusses on every subject's overall best response to derive the widget chart. Percentage change from Nadir SOD is also measured.
- Solid Tumors - Best Overall Response - This widget charts out the best overall response for every subject across all cohorts of the selected study. It also records the best percentage from baseline and gives the current status of the subject in the study.
- Solid Tumors - Disease Response and Clinical Classification Listing - This tabular listing tracks the treatment response on every tumor for every subject, across study days, and projects the best overall response to the treatment. The color codes have been updated to identify the type of treatment response obtained by the subject. The following color scheme will be applied:
- Progressive Disease - Color Code - #D93F23
- Not Evaluable/Null - Color Code - #B7B7B7
- Complete Response (CR) - Color Code - #79C431
- Stable Disease (SD) - Color Code - #F3B424
- Partial Response (PR) - Color Code - #0FBAE8
- New Lesion - Color Code - #946EA4
- Solid Tumors - The units of measurement will be seen in a column in the tabular listing, Tumor Identification and Results, which is part of the Solid Tumors tab in the SCE dashboard.
- Solid Tumors - The legend names as seen in all the widget charts displayed under the Solid Tumors tab in the SCE dashboard will be consistent across the widget charts. The legend key will be consistent and in the same sequence order in all the three charts, i) Disease Response Assessment, ii) Best Overall Response, and iii) % Change from Baseline SOD and this is defined as follows:
- Complete Response (CR)
- Partial Response (PR)
- Stable Disease (SD)
- Progressive Disease
- Not Evaluable
- The Solid Tumors components (Infographics & Widgets) can be selected to be part of the filter story that can be applied across all SCE domains.
New! Two Enhancements on GPP - Support for multiple clinical domains and Exposure widget
There have been two enhancements done on Graphical Patient Profile (GPP). These are:
- The GPP UX has been modified to show multiple clinical domains, such as, Vital Signs, ECG, and so on.
- The Exposure widget has been enhanced to show separate charts for each medication taken by the subject.
Enhancement! The Lab Charts to not show Screen Failure count
The Lab charts in the following dashboards have been updated to show subjects that have passed the screening or those who have been enrolled. The chart does not show subjects who have screen failed. If the Enrollment disposition is not available, then the Randomization disposition will be considered.
- Lab Spaghetti Plot - Absolute Value
- Lab Spaghetti Plot - Baseline Deviation
- Lab Chart - Absolute Value - SCE Dashboard
- Lab Chart - %Change from Baseline - SCE Dashboard
- Lab Listing
- Hy's Law Dashboard
- DILI Lab Results Over Study Day
- Graphical Patient Profile (GPP)
- Cohort Analysis - Average Result Trend
- Cohort Analysis - Subject Trend Against Baseline
Enhancement! Time logic in CI listings
If the entry of time is missing in the USDM or has not been collected in the EDC, then the table field in the listings should display as blank. The absence of a time entry for a record should be seen as no value or as a blank field.
The absence of date for any record in the listings should be seen as a blank field. No default date such as 01-Jan-1970 will be seen in case there is no date present for the record in the EDC.
The listings implementing this change are:
- MH Listing
- CM Listing
- AE Listing
- Lab Listing
Enhancement! SCE tabs are restricted on Therapeutic Area
The Solid Tumors tab in the SCE dashboard will show only studies that have Oncology as its therapeutic area.
Enhancement! Viewing options in Lab Spaghetti Plot – Baseline & Absolute Value & Labs tab (SCE dashboard)
The legend key, as part of the charts in LSP – Absolute Value & Baseline Deviation, now carry the option to view:
- All Subjects – By default, the LSP chart will be seen for all subjects. Disabling the toggle key Enable All Subject will show none of the subjects.
- Selected Subjects – When all subjects are not displayed on the chart, the user can be selective and choose only those subjects of interest from the legend key, whose lab chart the user wants to see.
- All Visits – By default, the toggle key Enable All Visits is disabled and none of the visits are highlighted or marked on the chart. Enabling this toggle will allow the user to see data for all the visits on the lab chart.
- Selected Visits – When the toggle key Enable All Visits is disabled, the user can select certain visits from the legend key and these specific visits of interest will be highlighted or will be marked on the lab chart.
Enhancement! Units for Higher & Lower Reference Range in all Lab Charts
Units will be visible or displayed for all higher and lower reference range values in all of the lab charts given below:
- Lab Spaghetti Plot - Baseline Deviation
- Lab Spaghetti Plot - Absolute Value
- Lab Chart - Absolute Value - SCE Dashboard
- Lab Chart - Baseline Deviation - SCE Dashboard
Enhancement! Death logic has been updated
The calculation of the count of deaths applied to the Death summary card in the SCE dashboard has been modified to take the count from the Death table instead of the Disposition table.
New! Addition of QS domain in CQS schema
Users will be able to see the Questionnaire (QS) domain in CQS Schema under Enter Architect Mode. This can be used for creating tabular listings.
Enhancement! Withdrawal Rate Logic
The values in the two table fields: Withdrawn and Withdrawal of Consent are clubbed together to calculate Withdrawn % and Withdrawal Rate. The dashboard that is using the improvised calculation is:
- Smart Clinical Explorer (SCE) dashboard
JIRA IDs applicable to the above stories in CI are: COM-8031, COM-6861, COM-6878, COM-6880, COM-6887, COM-6885, COM-6956, COM-7391, COM-8176, COM-5162, COM-6824, COM-8237, COM-7019, COM-7021, COM-7020, COM-7432, COM-8468, COM-8475, COM-8502, COM-8626, COM-8625, COM-8682, COM-8947, COM-8652, COM-8454, COM-8656
Smart Suggestions powered by DaLIA
New! Suggestion – EOT & AE & SAE
The aim of this suggestion is to highlight the abnormalities in count of SAE & AE and early EOT. The new suggestion shows the count of EOT (End of Treatment) which are due to SAE (Serious Adverse Events) and AE (Adverse Events). The input parameters for the same are: Non-Serious AE Count and Serious AE Count
New! Suggestion – Prediction of AE based on Lab Results & Demographics
The aim of this suggestion is to show the prediction of AE on a new subject that has enrolled and with a confidence score to understand better. A common Adverse Event (AE) can be predicted on a collection of new subjects with more or less of them having the same lab results and demographics. The input parameters are lab results and demographic data.
New! Suggestion – Prediction of early EOT based on AE, Demographics
The aim of this suggestion is to show the prediction of early EOT with a confidence score for better understanding. The input parameters are AE results and demographic data.
New! Suggestion – Correlation of early EOT with new lab data
The aim of this suggestion is to show the correlation of early EOT with new lab data derived, such as, VS (Vital Signs), PE, and EG. The input parameters are Labs, VS, PE, EG.
New! Navigation to Smart Suggestions Panel from SCE dashboard
When the SCE dashboard is loaded or selected from Analytics, the Smart Suggestions slider window popup will spring up to alert the user on relevant suggestions. The user may choose to close the slider window panel by clicking on the Cross icon at the top right corner of the panel.
The Smart Suggestions icon, however, will still be visible at the lower right corner of the SCE dashboard. The user may click on this icon at any time to view the Smart Suggestions. The Smart Suggestions icon also shows the count of unread smart suggestions.
The user may choose to disable the toggle that is present on the slider window popup. In this case, the count of new suggestions will not be seen on the Smart Suggestions icon.
New! Factors & tools influencing Smart Suggestions
A small introduction to Smart Suggestions and how they are being implemented can be accessed through the slider window panel. The user can click the Disclaimer link to open a window that gives more insights into the tools and factors governing Smart Suggestions.
New! Slider Window Panel for Smart Suggestions
The Smart Suggestions panel is enabled by default. Hence, when the user lands on the SCE dashboard, the slider window panel pops open to displays new suggestions. The user may choose to:
- Disable Smart Suggestions: When the user decides to disable seeing Smart Suggestions, the user would need to manually open the slider window panel by clicking on the Smart Suggestions icon and would then need to disable the toggle. On logging again into the SCE dashboard, the Smart Suggestions slider window panel will not pop open, but the Smart Suggestions icon will still be visible, giving the opportunity to enable or disable the panel for new suggestions.
- Close Smart Suggestions: When the user closes the slider window panel, if Smart Suggestions is enabled, then the user will not see the popup again even if the user switches between tabs of the SCE dashboard.
New! Combining AE intents with AND/OR/BUT/NOT operators
Multiple AE intents can be combined to yield results on the count of sites/subjects for a study/country/region in month/year.
New! Combining Lab Results intents with AND/OR/BUT/NOT operators
Multiple intents on lab results can be combined to yield results on the count of subjects for a lab result for study/country/region/site.
Scope & Calculations of New Intents – Combining Multiple Similar Intents
|Adverse Event (Handling multiple intents in one query)||Count:|
Serious/Non-Serious/Related/Unrelated/Severe/Mild AE combined with AND/OR/BUT NOT operators for study/country/site/subject in month year/year
|Count of Studies/Countries/Sites/Region based on AE intent||Study, Country, Region, and Site.|
|Lab Results (Handling multiple intents in one query)||Count of subjects for specific lab results combined with AND/OR/BUT NOT operators for study/country/region/site||Count of subjects with labresult intent in query||Study, Country, Region, and Site|
|Dalia's Response 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 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 Reports; response to such a query will be inaccurate or null.|
JIRA IDs applicable to the above stories in DaLIA are: COM-5338, COM-8291, COM-8149, COM-8124, COM-8127, COM-8250, COM-8212, COM-8232, COM-8944, COM-8945
Enhancement! Higher version of KeyCloak Server implemented
The KeyCloak server has been updated to a higher version, namely, version 16 since the prior version was outdated and was not working as expected.
Enhancement! LSAC Session Time Out
An LSAC application session will time out or log out the user in 15 minutes instead of a prior 30 minutes when the application is idle. This enhancement has been implemented at the account-level and hence will apply to all the users of that specific client account.
Enhancement! Setup Emails for New User
A new user who has subscribed to any of the modules in the LSAC application will receive two emails: i) The first one is for User Account creation which will direct the user to set up username, password and ii) Account email which will inform the user about the account they have been onboarded to.
JIRA IDs applicable for the above stories in LSAC Platform: LSPT-1924, LSPT-1707, LSPT-1818
Clinical Data Review
New! Creating Tasks on LSAC Listing Reports
An administrative user can now configure the task template to enable task creation on listing reports. Tasks can be viewed and associated cells of the listing that are part of the task can be highlighted. Tasks created on listings can be viewed from the listing.
These existing tasks can be accessed through the Collaboration dashboard and can be made available for view and certain edit action.
JIRA IDs applicable for the above stories in LSAC CDR: LCDR-277, LCDR-279, LCDR-281, LCDR-283, LCDR-310, LCDR-280
Clinical Data Hub
The following are the enhancements and new features that have been released as part of LSAC CDH 4.0.
New! Multi-tenancy Supported
LSAC CDH 4.0 is now a multi-tenancy application across all its modules.
New! OTB Functions
The following OTB functions have been added as part of LSAC CDH 4.0
Enhancement! Parallel execution with Master Job
A new USDM job can be initiated and run simultaneously with the Master Job.
New! eTMF Adapter Enablement
New eTMF adapter enabled in scale to load data in CDH.
New! Scalar Adapter Support on Multi-Tenant
SCALE framework is aligned with CDH multitenant architecture and ensures smooth data flow to CDH.
Enhancement! Vendor and Custom Functions Enhanced
File adapter has been enhanced to support multiple file formats. New set of custom functions are added to handle different file formats.
JIRA IDs applicable for the above stories in CDH (Clinical Data Hub): PDA-7669, PDA-6024, PDA-7146, PDA-6623, PDA-6624, PDA-7147, PDA-7148, PDA-8012, PDA-8198, PDA-7650, PDA-7867, PDA-7949, PDA-8014, PDA-8200
The following is the list of known issues as part of the LSAC v4.5 release:
Clinical Data Hub (CDH)
Display adapter description is not present for protocol first.
Deferred to next release.
The role access details are not visible in Data Browser for all the client accounts.
Deferred to next release.
Switching between client CDH accounts is not working on the LSAC application console.
Deferred to next release.
CDH-VAL: CDM extract job status fails for huge dataset file.
Deferred to next release.
The Add Task panel is not loading for any of the columns of the Data Refresh – Listing analytics.
After logging out as user: ‘firstname.lastname@example.org’, the other user is unable to log into this account and gets the following error message: ‘You are already authenticated as different user ‘email@example.com’ in this session. Please log out first.’
Deferred to the next release. Workaround is as follows:
Clear the user session from KC console or clear browser session. This will allow new users to login.
‘Filter Task’ checkbox near the ‘Highlight All Tasks’ checkbox is not working as expected in ‘Site Activation-Listing’ page.
On clicking on the Help icon in the Subject Visit dashboard page on AWS, the following error message appears: ‘Access Denied’.
Deferred. It is working as expected in all other user environments.
When the user clicks on the +4 button seen on highchair, the UI is breaking on Site Performance dashboard – Study
Deferred. Most customers are using laptops for accessing dashboards.
The PDF download of the Subject Visit Tracker widget in Subject Visit dashboard – Study does not print the following information:
- Symbols of visit compliance
- Protocol Version
- Last Visit Reason
- Unscheduled Visits
The following bugs have been fixed as part of the LSAC release 4.5:
Date picker, seen in the Calendar Days tab of the Subject Progression chart, is working as expected.
The tooltip information is fully visible for all the KPIs stated in the Site Summary table of the Site Summary dashboard – Site
There is no extra space between visit numbers as mentioned in the tooltip of the On-schedule Visits Trend chart in the Subject Visit Compliance with Schedule dashboard - Study
The tooltip, as seen under Adverse Events and Conmeds sorted by start time widget chart is showing the correct and calculated number of days
The tooltips seen on hovering over the Info icon of the column headings display complete information
The time period selection in the From and To fields of the date picker control in the Site Activation and Enrollment Over Time widget chart is working as expected.
With reference to: Site Activation dashboard – Study
Deselecting all columns, through the Show/Hide Metric, in the tabular listings of the SCE dashboard does not show the Load More button as no data is present.
On selecting specific columns to show, the dropdown that appears on clicking the Settings icon in the Prior & Concomitant Medication Listing table is working as expected.
With reference to: SCE dashboard - CI
The X-axis values of the AE Term Frequency chart are clearly visible in the PDF export document.
The legend key values are in Title Case for all the widget charts present.
With reference to: Safety Summary dashboard – Study
COM-8587, COM-7263, COM- 8444
The appearance of the legend key of the Subject Status Tracker widget table is as expected in the PDF export document.
The dropdown that appears on clicking the Settings icon of the Subject Status Tracker widget table is working as expected.
The Active-Yet To Enroll statistic captured in the Site Enrollment Status widget can be drilled down to reveal a listing.
With reference to: Enrollment Dashboard - Study
The dropdown that appears on clicking the Settings icon of the Lab Listing widget table in the Labs tab is working as expected.
With reference to: SCE dashboard – CI
The X-axis date range labels is same for both the high charts navigator handle and the Adverse Events by Month widget chart.
With reference to: Safety Summary dashboard - Study
The date displays in the same format in the CSV download as seen in the Data Refresh – Listing table.
[In AWS] The KPI widget chart shows more KPI charts when the user clicks on the tab that indicates more KPIs by a numeric seen on the tab
[In AWS] The Settings icon, which is part of the KPI widget chart, is working as expected.
With reference to: Site Performance dashboard - Study
The selections made in the Included Filters panel of the Task Analytics page are considered when showing task data on the Task Analytics page.
Other Defects in LSAC Analytics
|Other Defects in LSAC Analytics|
- The SDV data is not more than the Data Points completion data as seen in the Data Metrics dashboard.
- SDV% is visible for all studies that have the required data.
- The data in the Site Activation and Enrollment Over Time widget, in the Study Summary dashboard, is aligned and displaying data as expected.
- The data displayed in the Protocol Deviations widget, through the Year and Month tabs, is aligned and working as expected. With reference to: Quality Measures dashboard
- The Screen Failure - Country calculation has been modified and is seen correctly in the Scatter Plot widget chart.
- The data is visible in all columns of the Portfolio Summary dashboard and the dashboard is working as expected.
- The count of I/E Screen Failure Reasons is displayed correctly (in alignment with the count shown in the Screen Failure summary card)
- The Treatment Name seen in the tooltip is equating (matching) to the treatment name seen in the source table.
- The cohort name seen in the Portfolio Summary table is displayed as expected, and is in alignment to the column.
- Milestone data seen in 2 separate environments is matched correctly.
- Data labels are displayed correctly with their respective data, in all the tabs of the SCE dashboard.
- The AE data displayed in the Adverse Events and Concomitant Medications widget in GPP, is arranged on the basis of the AE start date.
- The line chart is well aligned with the bar chart and legends in the Protocol Deviations (by Month) widget in the Quality Measures dashboard.
- The counts displayed in the summary cards of the SCE dashboard are matched correctly to the source table and to the derivation logic used.
- The count displayed in the summary cards, namely, Count for CMs without Medical Indication and Site with Highest Subjects using CMs is equating to the count seen in the backend database (DB).
- The Planned Site Activation tool tip in the Site Activation and Enrollment Over Time widget displays the count correctly. With reference to: Enrollment dashboard
- Site 001 is being registered correctly in the filter story in the SCE dashboard.
- Records are matched correctly in the AE/SAE Trend widget where data is displayed across Study Days.
- The PDF export functionality in Site - Cross Study Performance dashboard is opening and is working as expected.
- The Lab Test filter in the Cohort Analysis - Avg Results Trend dashboard and in the Cohort Analysis - Subject Trend Against Baseline dashboard is working as expected.
- All SOCs are displayed in the AE Subject Count in the AE tab of the SEC dashboard.
- The summary card, namely, Site with Highest CM, displays the correct count.
- The Favorites tab under Home section is working as expected.
- The PDF downloaded in the Study Summary dashboard is opening as expected.
- The data seen under Medical History in the SCE dashboard is matching correctly with the data seen in the database (DB).
- The AE Time Series data is matching correctly with the data seen in the database (with respect to the dashboard).
- The data for country Hong Kong is being plotted correctly in the Adverse Events by Country widget in the Safety Summary dashboard.
- The stated time periods, namely, 1M and 3M are enabled in the Site Activation and Enrollment Over Time widget.
- The Current Subject Disposition data is displayed correctly on the dashboard.
- The tooltip data in ECG widget in the SCE dashboard, displays the correct time.
- The legend Failed Screen in the Patient Story widget in SCE dashboard is clickable.
- The Lost to Follow Up category in the Disposition Events is seen as a negative trend.
- AE data is visible in the Patient Story chart, when AE legend key is selected.
- The scroll bar for Preferred Term tab is working as expected in the AE Toxicity Profile widget.
- The Dosing tooltip details are visible in the Subject Progression chart.
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: firstname.lastname@example.org