Purpose & Scope
Life Science Analytics Cloud (LSAC) suite of applications is the leading AI-powered clinical analytics self-serving platform from Saama that seamlessly integrates and processes 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 that sponsors and CROs can optimize study planning, enrollment, compliance, productivity, and oversight.
The purpose of this document is to provide the release notes for version 4.6 of LSAC application. The release notes review the latest enhancements/new features of the LSAC application along with addressing known defects and fixed defects.
This document is intended to leave the business user with an understanding of the features and fixes to the LSAC application when upgrading from subsequent versions.
Release Summary
This release, LSAC v4.6, focuses on a new tab, namely, Country tab and several enhancements in Operations Insights (OI) as well as in Clinical Insights (CI). There are several new smart suggestions and enhancements in Smart Suggestions. There are new columns added to existing tables in LSAC USDM. The LSAC CDH application, as part of the LSAC CDH 4.2 release, has undergone retesting of the LSAC-CDH data pipeline to enable seamless flow of clinical data from the source pipeline to the analytics pipeline.
These enhancements and a few additions in LSAC Analytics will aid in providing business users with unique ways to interact with their data and will also help data analysts to drive the best analytical experience for their business decisions.
For this release:
- The analytics tab, Clinical Insights (CI) has prioritized several inputs from customers and has undergone several enhancements for better functioning of CI modules.
- The analytics tab, Operations Insights (OI) has introduced a new country tab in Executive Summary dashboard that gives key insights into country performance along with several key enhancements.
- Some of the modules of the application have undergone internal application security testing.
- There are new smart suggestions and more interactive tools have been introduced in Smart Suggestions.
- New columns have been added to existing tables in LSAC USDM.
- LSAC-CDH system integration was re-tested and re-validated to achieve a 'happy' path for data flow.
The features/enhancements are categorized, as follows, for better understanding and assimilation.
Abbreviations & Acronyms
The list of applied acronyms and abbreviations is mentioned below:
| Term | Definition |
|---|---|
| LSAC | Life Science Analytics Cloud |
| CDH | Clinical Data Hub |
| CI | Clinical Insights |
| OI | Operations Insights |
| 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 |
| DQ | Data Quality |
| CTMS | Clinical Trial Management System |
| PP | Patient Profile Focus area in application |
| USDM | Unified Study Data Model |
New Features/Enhancements in LSAC Application
The user stories tagged for this release LSAC v4.6 are all part of the JIRA epics inclusive of the LSAC release 4.6.
Operation Insights
Enhancement! Addition of widget-Protocol Deviation-Listing
The addition of the Protocol Deviation – Listing widget table to the Quality Measures dashboard - Study enables the user to fetch comprehensive details of every protocol deviation occurred in the study of interest. The tabular listing comprises some key points of data such as Protocol Severity, Protocol Category, Site ID, Subject ID, Protocol Start Date, Protocol End Date, and so on.
Selecting a protocol deviation category from the donut widget chart, namely, Protocol Deviations by Category, populates the widget table with protocol deviation records that correspond to the selected protocol deviation category.
One or more combined column searches in the widget table columns can filter out relevant records for easy access. Other UI tools also facilitate easy sorting, organizing and viewing of protocol deviation records. User has the option to reset the filtered listing and the admin user has the functionality to save the UI configurations.
Filtered records or all records can be downloaded as a *.CSV file that is marked with study ID and study name for better reference.
Enhancement! Replacing Infographics with Country Activation Details & Site Activation Details widget
The existing infographics in Site Activation dashboard – Study have been replaced with widget tables, namely,
- Site Activation Details table - This table lists the first site activation & the last site activation milestones. The planned date, reprojected date and the actual date of activation is also listed as it is realized.
- Country Activation Details table - This table lists the total planned and actual activated countries within the study. Apart from these highlights, this table also lists the planned date, reprojected date, and the actual date of country activation for every participating country and the delay (in days) incurred for country activation to be realized in that particular study. Selecting a country redirects the user to the Site Activation Listing widget that lists out comprehensive site details for the selected (clicked) country.
Enhancement! Flexible Time Scale in Milestone Cycle Time widget in Site Activation dashboard - Study
The addition of a flexible time scale (X-axis) allows the user to assess milestone cycle time developments through three different perspectives, that is,
- In Study Days
- In Study Weeks
- In Study Months
Milestone assessments compiled based on Site/Cohort/Country will reflect data according to the time scale selected.
Enhancement! Tabular listing of Study Site Progress Status
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
The widget Study Site Progress Status, in Site Activation Dashboard – Study, has been enhanced to include a tabular view that provides details of every milestone realized for every participating site of the study, over a period of time.
The tabular view enables the user to sort data based on one or more columns or to search for records based on one or more column values. Users can hide/show/freeze columns and admin users can save configurations. Also users can download the tabular data as a *.CSV file.
Enhancement! Study Site Visit Summary Infographic
The Study Site Visit Summary Infographic has been enhanced to show the below mentioned monitoring visits in predetermined order, as follows:
- First: Site Selection Visit
- Second: Site Initiation Visit
- Last: Site Closeout Visit
Enhancement! Widget – Actual & Planned Monthly Enrollment & Key Enrollment Milestones
The summary cards in Enrollment dashboard have been replaced with the tabular widget, namely, Actual & Planned Monthly Enrollment. This widget gives the actual and planned enrollment count for every active month since the study start date.
The enrollment counts close out when the LPLV/LPLD/study end date is reached. If LPLD/LPLV or study end date is null then the enrollment counts are displayed till the current date.
Specific time periods can be selected or entered in the calendar to view the planned and actual enrollment counts in that time period.
A new widget, namely, Key Enrollment Milestones, has been incorporated that identifies the progress on the First Subject In and Last Subject In milestones.
New! Country Tab in Executive Summary Dashboard
The addition of a new tab, namely, Country, in the Executive Summary dashboard provides key insights into the portfolio distribution summary of all studies being conducted in the selected country of interest. Some of the portfolio distribution areas are:
- Distribution by TA
- Distribution by Program/Compound
- Distribution by Indication
- Distribution by Country Status
- Distribution by Phase
- Distribution by CRO
The various KPI values, such as Site Activation Percent, Enrollment Percent, Enrollment Rate are indicative of the performance of the study portfolio in the selected country of interest.
The Country Details table gives a list of all studies being conducted in the selected country of interest. Every record contains comprehensive details of the study under selected country, such as, country milestones achieved, country status, indication, compound, active sites and so on.
The Country Details table can be searched on specific column values and the table can be sorted and organized for viewing through specific UI configurations.
Note: The country name in the Country Details table is clickable only if its data is mapped in the cqs.site table.
Enhancement! Rename the Subject Visit Dashboard – Study
The Subject Visit dashboard has been renamed as Subject Visit Compliance – Study under Focus: Study, in Operations Insights.
Enhancement! Site Activation & Enrollment Over Time widget
The Site Activation & Enrollment Over Time widget has been enhanced to show the following relevant details:
- Planned & Actual Enrollment metric will be seen as line charts in the Month tab.
- Cumulative Projected Enrollment metric will show three states of forecast viz., Optimistic Forecast, Pessimistic Forecast & Most Likely Forecast.
- Target Site Activation & Target Enrollment metric will be seen as line charts in both the Month and Cumulative tabs.
| Note: This widget is active on the following dashboards: i) Enrollment dashboard - Study, ii) Site Activation dashboard - Study, and iii) Executive Summary - Portfolio |
1
Enhancement! Site Activation dashboard – Study is now widgetized to avoid performance issues
Site Activation dashboard – Study is widgetized. By default, the widgets visible on the screen will be downloaded as PDF. The selected tab (of the widget) will be visible in the PDF copy, in case the widget has multiple tabs.
JIRA IDs that are applicable to the above stories in OI are: COM-8465, COM-9722, COM-6640, COM-8470, COM-8489, COM-8509, COM-8497, COM-8510, COM-6561, COM-9545, COM-5441, COM-9494, COM-9495, COM-9684, COM-9685, COM-9873, COM-9997, COM-10047, COM-10063, COM-10083, COM-10149, COM-10153, COM-10251.
Clinical Insights
Enhancement! Configurable tooltips in GPP
There is a provision to add configurable tooltips for Vital Signs & ECG.
Enhancement! Configurable tooltip for Adverse Event in GPP
The tooltips mentioned in the GPP configuration section ‘Adverse Events and Conmeds sorted by Start Time’ are not visible by default and can be configured as per the user requirement.
1
Enhancement! Expandable / Collapsible GPP categories
The GPP of a subject is categorized into various sections and each of them can be expanded or collapsed for better viewing purposes.
Enhancement! Source data for summary card - Cause of Death
The source data for the summary card – Cause of Death in GPP will be mapped from the ‘ddorres’ field in the Death table.
Enhancement! Configure up to 10 AE severities in GPP
A maximum of 10 AE severities can be configured in the GPP template. There will be 2 columns in the GPP that will show the severity text and the corresponding severity color.
Enhancement! Summary card - Last Dosage Date logic update
The logic of the summary card, namely, Last Dosage Date, in the Subject Progression dashboard has been updated to cover all possible scenarios to correctly display Last Dosage Date at study level.
1
Enhancement! Logic change for Relative Study Days calculation
In line with SDTM guidelines, relative study days calculation has been updated to exclude 0 days when assessment date and subject start date are the same. The following widgets in the listed dashboards are impacted by this change:
| Widget Name | Dashboard |
| Patient Story | SCE - DM tab |
| AE Time Series | SCE - AE tab |
| %Change from Baseline | SCE - Labs tab |
| Disease Response Treatment | SCE - Solid Tumors tab |
| Lab Result | Lab Spaghetti Plot - Baseline Deviation |
| Lab Result | Lab Spaghetti Plot - Absolute Value |
| Subject Progression | Subject Progression |
| AE Story | Subject Event Log |
| AE/SAE Trend by Study Days | Safety Summary dashboard - Study |
1
New! New column AEDIS added to CQS schema of AE Domain
Users will be able to see the AEDIS column under Adverse Events (AE) domain in CQS Schema under Enter Architect Mode. This can be used for creating tabular listings.
New! Addition of PE Domain in CQS Schema
Users will be able to see the Physical Examination (PE) domain in CQS Schema under Architect Mode. This can be used for creating tabular listings.
Enhancement! Updates to CM Listing
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:
- Addition of columns: Start Time Medication <cmsttm> & End Time Medication <cmentm>
- Backend logic updated to populate correct count as per the defined business logic.
Enhancement! SCE tab retention
Active/focused tab will be retained on:
- Page Refresh
- Study Switch on Global Filter
- Switch Account
Enhancement! Modification to handle truncated text on CM Summary Card
The tooltip has been remodeled to display complete CM name when character length exceeds 13, for the ‘CM with Highest Subjects’ summary card.
Enhancement! Logic Updates on SCE Summary Cards
The logic has been updated for the following summary cards:
- Site with Highest SAEs
- Top SOC with highest AEs
- Site with highest study drug related AEs
- Most frequent CM Indications
Enhancement! UI Level Logic updated for multiple summary cards of SCE
The count mismatch on count of subjects incurred earlier has been resolved and the following summary cards display the correct count as per the cqs db data present. These are:
- AE Tab:
- Subject with Serious Related AEs
- Subject with AEs
- CM Tab
- Total Count of Subjects with CMs
- Count of Subjects with Ongoing CMs
- MH Tab:
- Total Count of Subjects with Medical History
- Ongoing MH
- Ongoing Subjects with MH
Enhancement! Logic Update on Widget – Change from Baseline SOD
Backend logic updated on ‘Change from Baseline SOD’ widget to make the data consistent on the UI with respect to the data in the USDM table.
Enhancement! Label Updates in Subject Progression dashboard
The following labels of the summary cards in the Subject Progression dashboard have been renamed.
- From First Dosage Date to Study First Dosage Date
- From Last Dosage Date to Study Last Dosage Date
JIRA IDs applicable to the above stories in CI are: COM-9627, COM-9876, COM-9877, COM-9878, COM-9879, COM-9436, COM-9524, COM-9522, COM-9435, COM-9708, COM-9526, COM-7435, COM-9521, COM-9881, COM-9882, COM-9883, COM-9900, COM-10023, COM-10056, COM-9698, COM-10239
Smart Suggestions powered by DaLIA
New! Applying Smart Suggestions
A button, namely, Apply as Story, will be accompanied with every smart suggestion to allow the user to initiate the process of applying the smart suggestion as a filter story. The user can apply the smart suggestion by clicking on this explicit button.
New! Smart Suggestion Confidence Score Categorization
Confidence Scores for any ML/Rule based smart suggestion will be categorized as below:
- 'High' is greater than or equal to 75% and less than or equal to 100%
- 'Medium' is greater than 50% and less than 75%
New! Feedback on Smart Suggestions
The user can now express his/her Like (Thumbs Up) or Dislike (Thumbs Down) on a smart suggestion and this input is sent as feedback to the application in order to understand how useful this suggestion was.
Every feedback (Like/Dislike) is saved in the backend and can be pulled in audit trail reports and this would help improve on the quality of smart suggestions generated by the application.
New! Inputs/Ideas on Smart Suggestions
Users can share their ideas or inputs, to improve smart suggestions, by clicking on the ‘Bulb’ icon that appears on the Smart Suggestions panel. Clicking on the ‘Bulb’ icon opens up a dialog box where the user can enter ideas/inputs and then click Submit to save it in the backend which can be pulled from an audit trail report.
Enhancement! Location of Close button on Smart Suggestions
The Close button has been placed outside of the Smart Suggestions panel/box so that it is easier for the user to see it.
New! Suggestion – Count of Subjects with Serious AE – CM combination
The aim of this suggestion is to indicate the number of subjects with possible combinations of Serious AE & CM.
New! Suggestion – Count of Subjects with certain AE – MH & AE-CM-MH combination
The aim of this suggestion is to indicate the number of subjects with possible combinations of Serious AE, CM & MH.
1
New! Suggestion – Correlation between MH, CM, AE and Early EOT
The aim of this suggestion is to indicate the number of subjects with sequential events of MH, AE, CM leading to early EOT.
New! Suggestion – Pattern identification between Serious drug-related AE, DM, CM, Labs, MH and Early EOT
The aim of this suggestion is to indicate the number of subjects having patterns of events such as serious-drug related AE, DM, Labs, CM & Early EOT.
Enhancement! Suggestion - Change in Sentence Structures
The sentence structures of previously developed smart suggestions have undergone a change to make it more precise.
JIRA IDs applicable to the above stories in Smart Suggestions are: COM-9653, COM-9654, COM-9656, COM-9657, COM-9725, COM-9644, COM-9646, COM-9648, COM-9675, COM-9677, and COM-10069
LSAC USDM
Enhancement! New columns have been added to existing tables in cqs.schema
New columns have been added to existing USDM tables to support changes in the LSAC application for Operations Insights and for Clinical Insights. The changes are listed below:
| CDM Table Name | CDM Table Description | CDM Column | CDM Column Description |
| study | Studies | statusseq | Status Sequence |
| site | Sites | statusseq | Status Sequence |
| studycountry | Study Country | statusseq | Status Sequence |
| studymilestone | Study Milestones | milestonetype | Milestone Type (Original, Baseline, Planned, Actual, Reprojected) |
| sitemilestone | Site Milestones | milestonetype | Milestone Type (Original, Baseline, Planned, Actual, Reprojected) |
| countrymilestone | Country Milestones | milestonetype | Milestone Type (Original, Baseline, Planned, Actual, Reprojected) |
| ae | Adverse Events | aedis | AE Resulted in Study Discontinuation |
JIRA IDs applicable for the above stories in LSAC USDM: COM-9611
LSAC Application Security
New! Application Security Testing
The following applications have undergone internal application security testing for a more robust and efficient execution of the modules. These are:
- SCE Analytics
- SCE - Solid Tumors tab
- Hy's Law
- Tasks, Clinical Data Review (Collaboration Module)
- Executive Summary Analytics (under Portfolio)
- RACT-RBQM
- Oversight Scorecard
- Graphical Patient Profile (GPP)
JIRA IDs applicable for the above stories in LSAC Platform: COM-9336, COM-9335, COM-9337, COM-8639, COM-9642, COM-8907, COM-8607, and COM-9774.
Clinical Data Hub
The following are the enhancements and new features that have been released as part of LSAC CDH 4.2.
Application Integration of CDH with LSAC
The CDH integration with the LSAC application has been re-tested and re-verified from end-to-end to create a ‘happy’ path between both applications to ensure that the data pipeline is running seamlessly without any issues.
The integration of CDH application with LSAC application, through a validated data pipeline, enables study and patient source data (CDH) to be deployed seamlessly on Analytics (LSAC) dashboards for a quick and effective understanding of operations across clinical trials.
Enhancement! CQS-USDM mappings
The USDM mappings (as part of the system integration) have been revalidated to ensure existing and newly added variables, as shown in the table below, are mapped correctly to the CQS layer.
The new columns that have been added to the CQS layer are for Executive Summary – Portfolio (Analytics dashboard).
Kindly refer the section LSAC USDM for details.
JIRA IDs applicable for the above stories in CDH (Clinical Data Hub): PDA-8590, PDA-8591
Known/Open Issues
The following is the list of known issues as part of the LSAC v4.6 release:
Issue ID | Open Issues | Workaround/Status |
COM-10301 | The Illegal Request error is displayed when accessing the LSAC application. | Deferred to the next release. |
COM-7357 | The server is unable to accept new HTTP Connection request and displays the Illegal Request error on Analytics login. | Deferred to the next release. |
Operations Insights (OI) | ||
COM-10377 | Enrollment dashboard – Study: The dates selected from the calendar control (widget) are not reflected in the Site Activation and Enrollment Over Time widget (Enrollment dashboard – Study). | Deferred. Users can use the time slider that is present at the bottom of the widget for range selection. |
COM-10369 | Occurrence of a special character in the following:
| Deferred to next release. |
COM-10345 | In the Site Activation Listing widget, the status shown under Site Status column and the status seen in the Site Enrollment Status column are logically mismatched. | Deferred to next release. |
COM-10342 | The date format seen in the Site Activation & Enrollment Over Time widget (Site Activation dashboard – Study) is not consistent with the proposed date format (DD-MMM-YYYY). | Deferred to next release. |
The data format seen in the Site Activation Listing widget is inconsistent across its columns that show dates. | ||
COM-9668, COM-10470 | Donut chart values in the Distribution by Indication widget (Overview tab – Executive Summary – Portfolio) are overlapping with the legend key values. | Deferred. Users can reduce the Zoom% of the browser or look at the widget in Full Screen mode. |
COM-10330 | The count of total subjects is not matching with the Actual and Planned Monthly Enrollment and the Subjects Enrollment summary card (Enrollment dashboard – Study). | Deferred to the next release. |
COM-10276 | The donut chart seen in the Distribution by Indication widget (Country tab – Executive Summary dashboard - Portfolio) does not expand when the Enlarge icon is clicked upon. | Deferred to the next release. |
COM-10429 | Column Hide/Show/Freeze/Unfreeze functionality does not work in the Full Screen mode when Country Details widget (Country tab – Executive Summary – Portfolio) is expanded. | Deferred to the next release. |
Clinical Insights (CI) | ||
COM-9933 | The count displayed in the summary card Adverse Events of Special Interest (AE tab – SCE dashboard) is not matching with the corresponding count seen in the database. | Deferred to the next release. |
COM-10389 | An unknown disposition, namely, Discontinued Before Treatment, is seen in the legend key of the Subject Progression widget chart. | Deferred to the next release. |
COM-10353 | The count displayed in the summary card Site with Highest Study Drug Related AEs (AE tab – SCE dashboard) is not matching with the source (actual) count. | Deferred to the next release. |
COM-9796 | The DSTerm (Subject Progression dashboard – Patient Profile) does not appear in the legend key for a particular subject. | Deferred to the next release. |
COM-10435 | There is a data mismatch for Correlation of Early EOT suggestion that is observed in the SCE Smart Suggestion. | Deferred to the next release. |
Bug Fixes
The following bugs have been fixed as part of the LSAC release 4.6:
Issue ID | Issue Description | Resolution |
Operations Insights (OI) | ||
COM-9809 | The data is the Executive Summary dashboard PDF copy is misaligned and overlapping. | Columns in the PDF and date overlaps in the PDF are now aligned. Query by Study widget is aligned on the UI. |
COM-9811 | The Unscheduled Visit icon (multiple) is not positioned correctly in the Subject Status Tracker widget. | The Unscheduled Visit icon is positioned correctly in the Subject Status Tracker widget. |
COM-9911 | The Subject Visit dashboard is unable to fetch and all study protocol versions from the applied backend logic and is unable to display each of them on the dashboard. | All protocol versions present in the database are correctly displayed in the Protocol Version summary card of the Subject Visit dashboard. |
COM-9810 | NaN value is visible in the Key KPIs widget in the Study tab of the Executive Summary dashboard. | NaN value is not visible in the Key KPIs widget, and the widget is working as expected. |
COM-9826, COM-9550 | The legend key of the Subject Visit Tracker widget is incomplete on the UI display and in the PDF copy as it does not display legends for subject disposition events. | The legend key is complete and is displaying legends for all subject disposition events in the Subject Visit Tracker widget. |
COM-9606 | Applying the Overall Score Category filter does not show the right result in the Site Score column of the Oversight Scorecard. | The Site Score column shows correct values that correspond to the inputs specified in the Overall Score Category filter. |
COM-9771 | Join condition is not updated for rpt_ex, rpt_lab_information tables in cqs-default-schema.json. | Join condition has been updated. |
COM-9613 | Some study IDs are not hyperlinked in the Portfolio Summary dashboard – Portfolio. | All study IDs are hyperlinked in the Portfolio Summary dashboard – Portfolio. |
COM-10396 | The data from the Site Activation and Enrollment Over Time widget (Enrollment dashboard – Study) is not displaying correctly in the PDF copy. | The PDF copy of the Enrollment dashboard – Study is showing all the displayed data from the dashboard and is working as expected. |
COM-10311 | Overall PDF copy of the Enrollment dashboard – Study is inconsistent and missing information. | |
COM-10106 | Widgets are missing from the PDF copy of the Enrollment dashboard – Study. | |
COM-10328 | The data in the PDF copy of the Safety Summary dashboard – Study is missing, is not as per the sequence and is overlapping. | The PDF copy of the Safety Summary dashboard – Study is showing the displayed data from the dashboard and is working as expected. |
COM-10316 | The Info icon of USDM Data Refresh Date/Time is displaying truncated data on hovering over in Portfolio Summary – Portfolio. | Hovering over the Info icon displays the complete information. |
COM-10229 | The study level and arm level KPIs, in the Portfolio Summary – Portfolio, are not visible when the user clicks on Collapse All/Expand All link. | Initially only the study-level KPIs are visible but on clicking the Expand All/Collapse All link, all the study-level and arm-level KPIs are visible. |
COM-9960 | The Cumulative Enrollment data is missing from the AE/SAE Trend, for some recent months, (viewed by: Time and Month) in the Safety Summary dashboard – Study. | The Cumulative Enrollment data is displayed (visible) in the AE/SAE Trend for some recent months. (Viewed by: Time and Month). |
COM-9922 | The legend key of the Protocol by Category widget, in the Quality Measures dashboard – Study, is misaligned and is not displayed completely when the filter panel is open. | The legend key of the Protocol by Category widget is aligned and is displayed correctly even when the filter panel is opened. |
COM-9707 | Inconsistency in the data displayed in the CSV files of Subject Visit Compliance – Study and in the Study tab of the Executive Summary dashboard – Portfolio. | The data is consistent and is displayed correctly in both the CSV files. |
COM-9603 | The Group By option selection in the Portfolio Summary dashboard - Portfolio is not functioning properly and is not showing data as per the selection. | The Group By option is working as expected and the resultant data corresponds to the selection. |
COM-9918 | The heat map displayed under AE by Relative Study Week – Study/Country/Site turns grey when the Zoom functionality is performed. | The heat map does not turn grey when the user performs Zoom functionality and the tooltip shows complete information when hovered upon. |
Clinical Insights (CI) | ||
COM-10294 | The relative study days count is starting with zero (0) in Subject Event Log - Patient Profile. | The relative study days count is starting with 1 in the Subject Event Log – Patient Profile dashboard. |
COM-10283, COM-9913 | The top and bottom horizontal bar in the Concomitant Medication chart, seen on the SCE dashboard, are missing. | The top and bottom horizontal bar are visible in the Concomitant Medication chart. |
COM-10354 | The Adverse Events (Preferred Term) value displayed along the Y-axis of the AE Story widget chart is running across the widget chart causing overlay (overlap). | The Adverse Events (Preferred Term) value does not overlap or run across the AE Story widget chart and is contained in the defined boundary. |
COM-10355 | The Y-axis label is getting trimmed on the AE Story widget chart that is part of the Subject Event Log – Patient Profile. | The Y-axis label does not get trimmed or cut when several AE values are plotted on the AE Story widget chart. |
COM-10425 | The SCE dashboard is not displaying data on single study selection. | The SCE dashboard is displaying data when the user selects a single study. |
Clinical Data Hub (LSAC CDHv4.2) | ||
PDA-8615 | The Master Job log file and the Custom KPI job log file is not generated properly on job completion. | Resolved. The Master job file and the Custom KPI job file is generated properly and is showing all the logs correctly. |
Other Issues in LSAC Analytics | ||
Other Issues in LSAC Analytics
| Expansion of the Protocol Version (Executive Summary dashboard) section is not able to show all the records when it is enlarged – Subject Visit Compliance – Study. | The Protocol Version section is able to show the entire list of records for that specific study, when enlarged – Subject Visit Compliance – Study. |
CSV download of the table showing top/bottom 10 sites in Site Performance -Site show column mismatch. | The CSV column mismatch is now resolved and is working as expected. | |
The data in Study Milestone (Executive Summary – Portfolio) widget is overlapping with other dashboard data in the downloaded PDF. | The Study Milestone widget data is not overlapping, and the widget data is seen clearly in the PDF copy. | |
The widget chart, on the Subject Count by Latest Scheduled Visit – Study, is not presenting visits and data in sequence. | The widget chart in the Subject Count by Latest Scheduled Visit dashboard – Study is presenting visits and data in sequence. | |
KPI values are not matching in CDH application & LSAC OOTB dashboards. | The KPI values are consistent when displayed in CDH application and in OOTB dashboards. | |
Column Freezing functionality is inconsistent in Portfolio Summary – Portfolio. | The Column Freeze functionality is working as expected by aligning all the columns that are marked for freeze on the left side of the widget table. | |
Data displayed on the dashboard for CM Indication (Subject Progression – Patient Profile) is not matching with the backend data available at target CM. | The data displayed on the dashboard is consistent with the backend data available. | |
There is a date and time mismatch in the Start Date/Time medication column in Concomitant Listing. | The Start Date/Time format is approved and consistent in the Concomitant listing table. | |
The count displayed in the summary card Site with Highest Study Drug Related AEs (AE tab – SCE dashboard) is not matching as per user guide logic. | The count displayed in the summary card, Site with Highest Study Drug Related AEs, is validated. | |
Count of lab listing records with respect to the number present in database in not matching. | The count of lab listing records is consistent with the number of records present in the database. | |
Additional count is visible in the AE chart seen in AE tab – SCE dashboard. | The count is consistent with the data being presented in the AE chart (AE tab) and there is no additional count. | |
There is a time format and a Master Study Filter (MSF) issue in the Lab Spaghetti Plot – Absolute Value widget chart. | The time format and the MSF issue is resolved, and it is working as expected. | |
The filter Lab Test is not working properly in the Lab tab – SCE dashboard. | The filter Lab Test is working as expected. | |
The downloaded report of the data contained in the Subject Event Log – Patient Profile show rows with repeated data. | The downloaded data is validated and correct and there is no data duplicity. | |
The swimlane chart in GPP has an incorrect naming format of the Y-axis. | The y-axis naming format has been fixed in the swimlane chart in GPP. | |
There are issues in chart visibility in the AE and CM tabs of the SCE dashboard. | The chart visibility in the AE and CM tabs has been fixed and is working as expected. | |
Data is not visible in the UI but is seen when in the CSV download in the Subject Event Log – Patient Profile. | Data is now visible on the dashboard UI in the Subject Event Log – Patient Profile. | |
The applied filters are not seen on the Y-axis in the Subject Event Log – Patient Profile. | The applied filters are visible on the Y-axis in the Subject Event Log dashboard – Patient Profile. | |
There is a study filter issue in the Hy’s Law dashboard. | The study filter issue is resolved, and the study filter is working as expected. | |
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