Purpose
The purpose of this document is to provide details of enhancements and resolved (fixed) bugs that are defined in the scope of the 4.8 release of the Life Sciences Analytics Cloud (LSAC) application.
Acronyms & Definitions
Term | Definition |
AE | Adverse Events |
ALT | Alanine Aminotransferase |
AST | Aspartate Aminotransferase |
AWS | Amazon Web Services |
BILI | Bilirubin |
CI | Clinical Insights |
CQS Schema | Database with tables containing data related to OI, CI, and RBQM. |
CRA | Clinical Research Associate |
CSV | Computer System Validation |
CTCAE Grading | Common Terminology Criteria for Adverse Events (Grade refers to the severity of AE) |
DC | Saama’s Data Centre |
DM | Demographics |
DTC | A variable used for date of collection across clinical domains. |
eCRF | Electronic Case Report Form |
KC | Key Cloak Authentication Server of Saama |
KPI/KRI | Key Performance Indicator/Key Risk Indicator |
LSAC | Life Sciences Analytics Cloud |
MSF | Master Study Filter |
OI | Operational Insights |
OOTB/OTB | Out of Box/Out of the Box |
RACT | Risk Assessment & Categorization Tool |
RBQM | Risk Based Quality Management |
SCE | Smart Clinical Explorer (CI dashboard) |
SSO | Single Sign On |
UI | User Interface |
USDM | Unified Study Data Model |
Scope
The scope of the 4.8 release of LSAC includes some enhancements across the LSAC application, and addresses security vulnerabilities along with bug fixes in OI. This document also ensures that release 4.8 has been validated as per Saama’s validation process (Product Validation CSV Procedure).
Release Notes
The LSAC 4.8 release is aimed at the resolution of product bugs, and security upgrades that were identified during product delivery and is inclusive of some enhancements.
The features/enhancements are categorized and briefly discussed below for better understanding and assimilation.
- Clinical Insights
The Clinical Insights application enhances your analytics capabilities for more accurate data review and better decision making. Clinical Insights removes the lag time between the data requests and data availability by eliminating manual work, removing data management complexity, and presenting intuitive patient and cohort level dashboards.
Enhancement! Normal range calculation update in Lab Listing
The lower and upper limit of the range of values, will be specified for a given lab test in the Lab Listing tabular report.
Enhancement! Widget Chart - Baseline Deviation
The Baseline Deviation widget chart is now an integral part of two dashboards, namely, the Labs tab in Smart Clinical Explorer and Lab Spaghetti Plot – % Change from Baseline Deviation. Its calculation logic has been enhanced in the following ways:
- The Baseline Deviation is diplayed only when the Baseline flag is enabled.
- If there are multiple baseline visits for a subject, the most recent baseline visit will be taken up for calculating the percentage change from baseline for all visits.
- The new formula to calculating %Baseline Deviation is:
- %Baseline Deviation: (lab_result - lab result value at baseline visit)/(lab result value at baseline visit) * 100
- Note: If baseline flag (lbblfl) is not mapped, then % change for the subject will not be plotted on the chart.
Enhancement! Relative Study Days logic update in HY's Law dashboard
The Relative Study Days logic has been updated to not display a value of zero (0) for relative study day calculations. The following dashboards have been impacted due to the logic change:
- Hy's Law dashboard
- DILI Lab Results Over Study Day
- AST vs BILI
- ALT vs BILI
Enhancement! Logic Update in summary card - Total Subjects with Related AEs
The logic of summary card, Total Subjects with Related AEs (in AE tab of Smart Clinical Explorer) has been updated as follows:
- Total Subjects with Related AEs – Count of distinct subjects with AERELNST = All except anything like ‘%No%’, ‘%Un%’, ‘Null’, “(blank)”, ‘Incomplete Data’, ‘Missing’. (Possible terms as an example – ‘No’, ‘Not Related’, ‘Null’, ‘Blank’, ‘Unrelated’, ‘Unknown’, ‘Not Applicable’, ‘Incomplete Data’, ‘Unlikely Related’, ‘Missing’).
- LSAC Platform
The LSAC Platform is the underlying inherent single, and secure access gateway to all the applications of Saama Platform. It is an active hub for various administrative activities, user access and account management.
New! New UI for User Login and User Registration
Design changes have been implemented on the User Login and User Registration pages to render a better UI experience.
Enhancement! Update Components with Known Vulnerabilities
The current JQuery version has been updated to the latest version to patch the known vulnerabilities in LSAC Platform.
Enhancement! Increased time for User Account Setup (for Legacy Product Users)
The account setup activation link received in the email – “Saama – Setup Your User Account”, at the time of user registration, will remain active for 7 days (168 hours) from the time of the receipt of the email.
- Security Testing & Fixes
Security testing & fixes are conducted on LSAC applications at a regular interval or when required.
Security Upgrade! Yellowfin Upgrade
The application Yellowfin KPI Studio has undergone an upgrade, and its new image is now visible. Security checks have been performed on Yellowfin Studio.
Security Upgrade! KC Upgrade
The Key Cloak authentication server of Saama has undergone an upgrade to identify and remove security vulnerabilities.
Performance Upgrade! Performance Tesrting of CI dashboard
The performance of the Lab Spaghetti Plot – Absolute Value dashboard has been increased to render data on the dashboard in minimum to zero lag time. Please note Cohort filter is set mandatory in order to enhance performance. Even if the Cohort value is Null, the dashboard will still render data.
Security Upgrade & Performance Upgrade! Performance Tesrting of OI dashboards
The following OI dashboards have been tested for application security and application performance. These are categorized as per their focus areas:
OI dashboards |
Portfolio Executive Summary dashboard – Study tab
Study Enrollment dashboard – Study Site Activation dashboard – Study Study Summary – Study Subject Visit Compliance – Study
Centralized Monitor Open Query Aging by Site Missed Visits by Site Monitor
Centralized Monitors - ATRI Infusions Stopped or Interrupted by Site Subject Screen Failure vs Randomization KRI Monitor Subject Randomization KRI Monitor |
Security Upgrade! Security Risks addressed in Clinical Insights
Vulnerabilities or security risks have been identified and addressed for the following CI dashboards in LSAC Analytics:
CI dashboards |
Patient Profile Smart Clinical Explorer Lab Spaghetti Plot – Absolute Value Lab Spaghetti Plot – Baseline Deviation |
Bug Fixes
Below is the list of Resolved Issues/Closed Issues from this release:
ID # | JIRA Description | Resolution |
Operational Insights (OI) | ||
COM-11195 | Issues with Monitor: Open Query Aging by Site:
For some past dates, data is not available on the UI. | Closed. |
COM-11196 | Time period filter in Centralized Monitoring is not working as expected. The monitor goes blank when the time period is reset or set to initial values. | Closed. |
COM-11197 | The following issues were sited in custom monitors:
| Closed. |
COM-11200 | The time frame filter is breaking (visually distorted) when viewing the KPIs on the monitor. | Closed. |
COM-10345 | In Site Activation Listing, the Site Status column value is not in logical alignment with the value in Site Enrollment Status column. | Closed. |
COM-11412 | The Subject Status Tracker widget, in the Enrollment dashboard, is displaying projected dates for subjects that have exited/withdrawn from the study. | Closed. |
COM-11492 | The Y-axis and Z-axis line graphs are displaying Site Activation count in decimal values instead of displaying it in whole numbers, in Site Activation & Enrollment Over Time widget. | Closed. |
COM-11499 | On clicking the Zoom button in Site Activation & Enrollment Over Time widget, in the Executive Summary dashboard, the date picker control is not showing the default dates. | Closed. |
COM-11506 | The Subject Visit Tracker widget, in the Subject Visit Compliance dashboard, is displaying projected dates for subjects that have exited/withdrawn from the study. | Closed. |
Known Bugs/De-Scoped Functionalities/Limitation
Below is the deferred defect from the Past release. There are no deferred defects from the Current release.
ID # | JIRA Description | Impact & Justification | Product Release No. |
COM-11450 | The CM data points seen in the pop-up by hovering over the Subject ID, in Patient Story widget in DM tab of SCE, shows value as 1, despite there being multiple CM data points. | Deferred. This is not a bug. It is a product enhancement and was not part of the initial requirement. The change requires a logic update in X-axis to respond to time variation in the current widget. Severity: Low. | LSAC v4.7 |
As mentioned in the Quality Summary Report, LSAC-QSR-4.6 (AWS + DC), there are no deferred issues from LSAC v4.6. | |||
References
Sr. No. | Document Name | Document ID |
1 | Project Change Request and Impact Analysis – LSAC v4.7 | CR-LSAC-017 |
2 | Quality Plan for LSAC, Version 4.8 (AWS + DC) | QP-LSAC-4.8 (AWS + DC) |
3 | Requirement Specification Document - LSAC | FSQ-LSAC-4.8.0 |
4 | Quality Summary Report for LSAC, Version 4.8 (AWS + DC) | LSAC-4.8-QSR-001 |
| 5 | Product Validation CSV Procedure | 1378 |
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
Annexure
Not Applicable.