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 4.3 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

The LSAC CDH application, as part of the LSAC CDH v4.3 release, has been enhanced to accommodate new changes in the SCALE Inform Adapter to meet the requirements of downstream applications (as of now, SDQ) for data consumption. Some deferred issues have been included as part of LSAC CDH v4.3 release.

Abbreviations & Acronyms

     The list of applied acronyms and abbreviations is mentioned below:


    

TermDefinition
LSACLife Science Analytics Cloud
CDHClinical Data Hub
PDA/PDLPatient Data Analytics/Patient Data Layer
ODLOperation Data Layer
ODM
Operational Data Model
EDCElectronic Data Capture
CDL/CDMCommon Data Layer/Common Data Model
Medidata Rave
Cloud Based Clinical Data Management System
BioStat
Biology & Medical Statistical Software
DQData Quality
CTMSClinical Trial Management System
AWS
Amazon Web Services


New Features/Enhancements in LSAC Analytics

     The user stories tagged for this release LSAC CDH v4.3 are all part of the JIRA epics inclusive of the LSAC CDH release 4.3. 


Data Ingestion

Enhancement! Oracle Inform Adapter has been modified to support SDQ data ingestion


The Oracle Inform adapter has undergone code changes to support and include new columns (in existing tables) that will support the ingestion of EDC operations source data for the SDQ application.


JIRA IDs applicable for the above stories in LSAC CDH v4.3 are: PS-235, PDA-8640

Known/Open Issues

The deferred issues, as part of the LSAC CDH v4.3 release, are listed as follows:


Issue ID

Issue Description

Severity

Workaround/Status

Impact & Justification

PDA-8758

When the subjectid value is updated in the CRF form, the column: subject_enrollment_number is not updated in cdhops_subject table and the subjectid is not updated in other clinical datasets.

Major

Deferred. This will be addressed as a hotfix in release LSAC CDH v4.3.2

The impact will be on the incremental data load when the SubjectId is changed and there is no impact when the subjected is updated in the Full load option in the customer-specific environment. This issue will be addressed in the next immediate release.

PDA-8852

The submitted values that are cleared, for a CRF form with log/non-log combination, are not being reflected in incremental load.

Major

Deferred. This will be addressed as a hotfix in release LSAC CDH v4.3.2

The impact is on the incremental data load and there is no impact on the Full load option in the customer-specific environment. This issue will be addressed in the next immediate release.

PDA-8733

An Inform Scale job that is in execution is marked as Failed when the LSAC server is down.

Minor

Deferred to future release. Workaround: The log pull must happen from the last attempt and not from the first retry attempt.

There is no major impact. The user is required to re-trigger the job when the server is up. As the workaround is mentioned and the functionality was designed as per the planned release scope of LSAC CDH v4.3, this issue will be addressed in the future release.

PDA-8740

For a scale job, the Trigger button is enabled (to trigger/start a job) even when the current api pdl job is running.

Minor

Deferred to future release.

There is no impact on functionality. This feature will add protection on multiple job submissions. The job fails if multiple jobs are submitted and hence there is no data loss.

PDA-8764

In the Data Browser (Metadata section), the data length of most columns in cdhops table and of some columns in cdhclinical tables is stated as Null.

Minor

Deferred to future release.

There is no impact on the functionality. Instead of seeing a blank field there is a Null value visible in the UI. This issue will be addressed in the future release.

PDA-8798

The Audit Trail issues as identified in the CDH application are as follows:

  1. Email/UserID should be mentioned instead of First Name and Last Name when viewing the list of users in Audit Trail.
  2. Comments for making changes should be specified under the ‘Change Reason’ column that currently reads as ‘New Addition’ column.
  3. Details of previous versions of Metadata and Audit Trail that are implemented, are not captured.
  4. Dataset’s metadata is in Draft state and is displayed in the system, but its creation details are not captured anywhere.
  5. No option is present to download the Audit Trail.

Medium

Deferred to future release.

This is not actually a defect. This will be addressed as an enhancement of the Audit Trail feature and will be taken up in future release.


Fixed Issues

There are no fixed issues as part of the LSAC CDH v4.3 release.

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