Data Map and Quality of Life Changes Abound in SAM 3.1
New features and application updates for Smart Auto Mapper (SAM) and Hub Administration (HA) release in tandem in the SAM 3.1 release. Inbound and outbound API support for Hub Administration provides
What’s New for SAM in the 3.1 Release:
Hub Administration (HA)
[New] Access Fine Grained Data on the Hub Administration Home Screen
A new feature – Fine Grained Access (FGA) – is visible on the Home Screen of the Hub Administration application. This feature allows the user to configure column-level rules for datasets, and allows masking of column data when raw data is ingested from HA to SAM. The FGA feature can also be applied so that users can modify a study that has already been onboarded:
- Allows addition of column-level FGA rule.
- Allows editing, deleting, viewing a column-level FGA rule.
- Allows changes to metadata based on configured FGA rule.
- Allows data ingestion to SAM based on the configured FGA rule.
- Allows masking of table-level, column-level data, dataset-level data, based on the FGA rule configured. The list of masked rules can be seen by the Hub Administrator for a study.
- Allows this feature to be applied to a blinded study as well.
For a specific study, the change in FGA rules will be recorded and an audit trail will be generated. For an existing list of FGA rules, users will be able to select the FGA rules that may be considered for implementation in the study.
[New] Inbound API support for Hub Administration
Inbound API support will enable users to write data back to the HA Data Lake. This feature is only applicable to coding datasets.
[New] Outbound API Support for Hub Administration
Outbound API support feature will enable the user to retrieve data, in JSON format, from the data layers, namely, PDL, Pre-Conformance, and Conformance, of the patient pipeline. The ability to use this feature will be determined by the study access defined for each user in the application.
[New] Access to the Hub Administration Database
Authorized users can now connect the HA application to the SAM database using a reporting tool, such as JReview or Spotfire.
[Enhancement] Processing SAS Datasets
User can now process file-based datasets with the extension ‘*.sas7bdat‘ when progressing towards file-based Source System Management.
[Enhancement] Processing files without the ‘date’ timestamp
Users can now process files, for a file-based connection, without providing a ‘date’ timestamp.
[Enhancement] More effective EDC RAVE data processing
With the help of Biostat adapters, HA and SAM will be able to process EDC Rave data for all CRF pages and will be able to skip the ODM dataset pulls.
[Enhancement] Modifications to metadata structure
The metadata API has been updated for the following connections:
- File-Based Connections
- Database Connections
[Enhancement] Improved Metadata Import
A metadata extract from the any source storage system, such as file-based, API-based, and DB based, will include the following columns in the sequence order below:
- Dataset Name – Name of the dataset
- Dataset Label – Description of the dataset
- Column Sequence – Column Sequence Number
- Column Name – Name of the column
- Column Label – Column Description
- Column Format – Datatype format
- Data Type – Data type of the column
- Data Length – Length of the column
Smart Auto Mapper (SAM)
[New] ML Model for Predictions in Pre-Conformance
The implementation of a pre-trained Machine Learning model within SAM has equipped SAM with strong ML capabilities that provide users with highly accurate predictions on Pre-Conformance data and improves the MAP creation process.
[New] P21 Report Generation for TDD
Users can now generate Pinnacle 21 reports from underlying XPT files that are present in the TDD domain.
[New] Global Metadata Setup
The user experience for an on-boarded new client has been enhanced with the addition of pre-approved global modules during the metadata setup process in Global Administration. These include:
- Pre-Conf DEL
- Conf DEL
- Conf Standards
- Target Codelist
[Enhancement] Domain labels in XPT files
To better align with Conformance data layer standards for XPT files, the ‘Domain’ label will be the same as defined in the Standard page under Global Metadata Management when generating an XPT file.
[Enhancement] Copying of AutoMaps – Conformance
The Conformance DEL Elements added or modified after study registration, under Global Administration, can be copied to the Study Layer.
[Enhancement] OTB Functions
The functional logic of the following OTB functions have been enhanced:
- Copy (Row Operation)
For an enhanced user experience, these OTB functions are now sorted in alphabetical order within SAM.
[New] OTB function – CHAR_TO_NUM
A new OTB function, CHAR_TO_NUM, has been added. It converts character values to numeric values.
[Enhancement] Modifying Domain Keys
Approved Domain Keys can now be edited or modified so that users can customize these keys per study requirements.
[Enhancement] XPT Reports for Pre-Conformance Layer
XPT reports can now be generated on the Pre-Conformance layer irrespective of the MAP statuses (that is to say, even if there are no maps to or from the pre-conformance layer)
[Enhancement] New columns in Snapshot Management
New columns, namely, Snapshot Version and TMF ID have been added to the Snapshot Management module to enhance the user experience and user accessibility of preserved data.
[Enhancement] Improved search function in AutoMaps
The search functionality has been implemented at the column-level within the Auto Maps module to enhance user experience.
[Enhancement] Improved logic on Import/Save button
The Import button and Save buttons will be disabled in the Global Administration & Study Administration modules until the First Import process is completed.
[Enhancement] Consistent Headers
Headers present in files, exported from other references, will remain unchanged when the exported file content is rendered in the UI.
[Enhancement] Auto Map function
The Auto Map module will enable the user to execute a dry run of the Maps, even if the underlying custom functions are in Draft state, awaiting approval.
[Enhancement] Leading Zeros Preserved
The application will preserve all the leading zeros present in data columns of imported files.
[Enhancement] Modal Window – Logic Updates
The UI prompts for modal windows are disabled when the user selects one or more OTBs with the Map module.
[New] CO Data Preview
CO Data will be available for preview on the Map Summary page, under Maps module, so that the user has visibility to CO domain data.
[Enhancement] Deletion of Inactive Scheduling Job
The Delete operation will not be possible for Active or Running jobs.
[Enhancement] SAM Data Browser Supports FGA
If a Masking Rule is applied on a dataset, then the masked columns will not be visible in the SAM Data Browser and will present users with a restricted view.
[Enhancement] Browser – Snapshot Management
Preserved Datasets of the archived snapshot will be visible in the Read Only Mode within the Data Browser module across the Data Layer.
[Enhancement] Reference Files displayed
The selected files will be displayed as a title under the ‘Other Reference’ section on the Reference List page.
[Enhancement] Job Scheduling workflow
Some of the known limitations that occurred when scheduling a job in the Job Management module have been addressed.
[Enhancement] Dataset & Variable Names
The Dataset names and Variable names will be uniquely identified within the Create Map module to avoid duplication.
[Enhancement] Flag Deleted Records
All deleted records will be moved to downstream application with a flag set value of ‘D’ tagged to each of them and will thus keep all previous values intact.
[Enhancement] Warning Messages for SAM ingestion
Warning messages will be displayed if the CDH Trace ID and CDH Record ID is missing in the dataset when it(dataset) is being transformed for SAM ingestion.
[Enhancement] SAM process updated
The dataset transformation for SAM ingestion will be deemed unsuccessful if the exceptional datasets have blank/duplicate Trace IDs and CDH record IDs.