Scope

The scope of the 4.7 release of LSAC includes new features/functionality as well as bug fixes and known issues. This document also ensures that release 4.7 has been validated as per Saama’s validation process (Product Validation CSV Procedure).

Enhancement! Complete milestone names in Executive Summary dashboard – Portfolio

The data in multiple Parquet files is loaded in discrete portions, which are subsequently persisted in a temporary table. These individual segments are then amalgamated and persisted in the main table.

1. Complete names of milestone labels are available in tooltip in Study Details table in Study tab when user hovers over the Info icon that is next to the column name.
2. Complete names of milestone labels are available in tooltip in Country Details table in Country tab when user hovers on the Info icon that is next to the column name.

Enhancement! Open Filter Panes on Dashboards

The filter panes will be displayed on the left side, by default, when the dashboard is opened/loaded. This setting is applicable to all dashboards except to the following OI dashboards:

Enhancement! Site Performance dashboard

There is visibility of sites with KPI value as ‘zero’ in the existing widgets (charts and tables) of the Site Performance dashboard.

Enhancement! Addition of columns & UI updates on ‘Actual and Planned Monthly Enrollment’.

The following enhancements have been done to the Actual and Planned Monthly Enrollment widget:

1. The widget has been renamed to 'Actual and Planned Enrollment'.
2. The following metrics have been added to this widget:
   1. Planned Enrollment (Cumulative)
   2. Actual Enrollment (Cumulative)
   3. Enrollment %
3. Existing rows will be renamed as Planned Enrollment (Monthly) and Actual Enrollment (Monthly).
4. Cumulative Actual Enrollment will stop showing when the Last Patient In date is identified for the study. The date column will be highlighted with color and an Info icon will show the milestone label and date in the tooltip.

Enhancement! Addition of new columns to Listings relevant to Subject Visit Compliance

Three new columns, namely, PI Name, PI Email, and Subject Status have been added to the following listings accessible in OOTB listing and in KPI Studio Listings. PI Name and Subject Status are also added to the multi-select local filter pane of the following listings.

1. Subject Visit - Listing - Site
2. Latest Subject Visit - Listing - Subject
3. Subject Visit - Listing - KPI Studio
4. Latest Subject Visit - Listing - KPI Studio

Enhancement! Updates in AE Count logic for counting AEs from Consent Date.

The AE Count logic has been enhanced to count AEs from Consent Date. The following dashboards have benefited from the change:

Enhancement! Reordering of Infographics in Study Summary dashboard – Study

Study ID and Medical Indication are now added to the Infographics section in Study Summary dashboard and the infographics information is ordered as follows:

1. Study Name
2. Study ID
3. Therapeutic Area (Newly added)
4. Medical Indication (Newly added)
5. Phase
6. Study Start Date
7. Study End Date

Enhancement! Change in the Subject Days calculation logic

The minimum date logic, as part of the Days Calculation, has been updated and has been applied across the following dashboards for harmonization in data deliverance.

The details of the requirements are available in Requirement Specification Document (Reference Document ID: , v12.0)

• 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! Calculation/Title Updates on SCE Summary Cards

Summary cards, in the following domains of the SCE dashboard, have undergone a calculation and/or title update.

Enhancement! Rearrangement of Summary Cards in SCE dashboard

Summary cards in the AE, MH, and CM tab (domain) of the SCE dashboard have been rearranged based on the Study/Event level categorization.

Enhancement! Updates on the AE Subject Count table

The label ‘Randomized Subjects’, in the AE Subject Count table, has been changed to read as ‘Enrolled/Randomized Subjects’ and column logic has been enhanced to handle scenarios when randomized subjects are not present in the study.

Enhancement! Updates to the Adverse Event Listing 

The updates to the Adverse Event Listing, present in the AE tab of SCE dashboard, are listed as follows:

1. The existing 'rpt_ae' logic has been updated to display the correct count of records in the Adverse Event Listing.
2. New column, namely, 'AE End Day' has been added.
3. Column logic has been updated to retrieve the CTCAE grading from the USDM table and not from the PLO layer.

Enhancement! Time display updates to Adverse Event OOTB Listing

The Start/End Time columns, in the Adverse Event OOTB Listing, show the user-configured time value.

Enhancement! Enhanced performance of ‘Adverse Event – Toxicity Profile: Study’ dashboard.

The performance of the Adverse Event – Toxicity Profile dashboard in the focus area Study has been enhanced as per the NFR requirements.

Enhancement! Error fixes on CQS Schema

The ‘endpoints valid’ warnings have been fixed on ‘Edit CQS Schema’.

Enhancement! Column addition to USDM layer

A new column ‘AETRTEM’ has been added to the AE table in the USDM schema.

Enhancement! Column headers to CM table & MH table

The column labels have been updated in the Concomitant Medication table and in the Medical History table, present in the CM tab & MH tab respectively of the SCE dashboard.

Enhancement! Calculation Logic Update in PLO layers

The minimum date logic, as part of the Days Calculation, has been updated and has been applied across the following dashboards for harmonization in data deliverance.