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:
| Term | Definition |
|---|---|
| LSAC | Life Science Analytics Cloud |
| CDH | Clinical Data Hub |
| PDA/PDL | Patient Data Analytics/Patient Data Layer |
| ODL | Operation Data Layer |
| ODM | Operational Data Model |
| EDC | Electronic Data Capture |
| CDL/CDM | Common Data Layer/Common Data Model |
| Medidata Rave | Cloud Based Clinical Data Management System |
| BioStat | Biology & Medical Statistical Software |
| DQ | Data Quality |
| CTMS | Clinical 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:
| 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