Purpose

The purpose of this document is to provide the list of known issues as well as bug fixes for the 4.5 release of the Clinical Data Hub (CDH).


Acronyms & Definitions

Term

Definition

CDH

Clinical Data Hub

PDA

Patient Data Analytics

PDL

Patient Data Lake

ODL

Operation Data Lake

CDM

Common Data Model

USDM

Unified Study Data Model

EDC

Electronic Data Capture

DQ

Data Quality

SDTM

Study Data Tabulation Model

AWS

Amazon Web Services

KPI

Key Performance Indicator

DEL

Data Element Library


Scope

The scope of the 4.5 release of CDH includes bug fixes and known issues. This document also ensures that release 4.5 has been validated as per Saama’s validation process (Product Validation CSV Procedure).

Release Notes

There are no new features/enhancements as part of this release.


Known Bugs/De-Scoped Functionalities/Limitation

Below is the list of Deferred bugs from Current and Past releases:


ID #

JIRA Description

Impact & Justification

Product Release No.

PDA-9232PLO fails when it is triggered through USDM scheduled job.There is no impact on CDH v4.5 due to this defect. This defect is unrelated to the CDH v4.5 scope or bug fixes. A detailed RCA is needed to find the cause of failure pertaining to the study setup data ingested into data models.CDH v4.5

PDA-9264

During the incremental upload of parquet files into the CDH system, the DQ rule is active when there is a destructive change in metadata.

There is no impact on CCR 4.5 due to this defect. The observation reported on the parquet file needs to be analysed further. However, since it does not impact the ODL data loading functionality, this issue is deferred and will be addressed in a future release.

CDH v4.4.1

PDA-9263

The ODL job is failing when there are multiple duplicate columns in dataset and one of the columns BK is incremental in nature.

There is no impact on CDH 4.5 due to this defect. The issue of duplicate columns in the dataset is not preventing the ODL job from functioning. However, it needs to be reviewed and analysed to determine the best solution for executing the job. Therefore, this issue is deferred and will be addressed in a future release.

CDH v4.4.1

PDA-9262

The ODL job is running successfully, instead of throwing an error, and inserting all records when the dataset has duplicate records and duplicate business keys. 

There is no impact on CDH 4.5 due to this defect. The PDL/ODL history table is being populated with duplicate records and duplicate business keys without throwing an error and without experiencing any data loss. A thorough analysis is needed to identify the resolution and apply the fix. This issue does not prevent the ODL Job function from working, and hence this issue is deferred and will be addressed in a future release.

CDH v4.4.1

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.

 

There is no impact on CDH 4.5 functionality due to this defect. This feature will add protection on multiple job submissions. The job fails if multiple jobs are submitted and hence there is no data loss.

CDH v4.3

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.

There is no impact on CDH 4.5 functionality due to this defect. Instead of seeing a blank field there is a Null value visible in the UI. This issue will be addressed in the future release.

CDH v4.3

PDA-8798

The Audit Trail issues as identified in the CDH application.

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

CDH v4.3

PDA-8127

Display adapter description is not present for protocol first.

There is no impact on CDH 4.5 due to this defect. There is no description available for individual fields in the database and for this reason it's not showing any help info for protocol first. Once the description is added for Protocol First it would be visible. This is a minor defect, with minimal impact, hence deferred to future release. Discussion is agreed & approved by Product Owner.

CDH v4.0

PDA-8142

Role access details not visible in Data Browser for all accounts.

There is no impact on CDH 4.5 due to this defect. CDH shows the user’s role for all applications thus if it is not visible in the data browser then user can check the role in the Global/Study admin applications. It is not impacting any functionality in the system hence deferred to future release. Discussion is agreed & approved by Product Owner.

CDH v4.0

PDA-8385

DQ Recon Job not working, not able to see data on DQ.

There is no impact on CDH 4.5 due to this defect. This will be a fix in the next release due to its impact on timeline and will be shipped as a code fix.

CDH v4.0.3


Bug Fixes

Below is the list of Resolved Issues from this release: 


ID #

JIRA Description

Resolution Status

PDA-9027

Need to upgrade the CQS schema in CDH to be compliant with DB enhancements of LSAC 4.7 release.

Resolved.

PDA-9024

The Custom KPI job is failing consistently due to deadlock issue. There is a need to re-trigger the jobs for their successful completion.

Resolved.

PDA-8796

The version_folder tables are not loaded when the RAVE_ODM job is executed.

Resolved.

PDA-8733

The latest audit logs are not downloadable for Scale jobs when there are 3 re-try attempts in airflow.

Resolved.


References


Sr. No.

Document Name

Document ID

1

Project Change Request and Impact Analysis – CDH 4.5

CR-CDH-013

2

Quality Plan - CDH 4.5

CDH-4.5-QP-001

3

CDH - Requirement Specification Document

CDH-RSD-001

4

CDH 4.4 - Quality Summary Report

CDH-4.5-QSR-001

5Product Validation CSV Procedure1378


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.