December 2024 Medidata Global Education Monthly Course Digest

Explore Rave Audit Data Trail Using Audit Trail Review

Overview:

This new eLearning course will show you how to leverage Large Language Models (or LLMs) and Generative AI to easily explore complex audit trail data sets from Rave

Data Surveillance: Use AI Reconciliation

Overview:

In this course, you will learn about:

• Introduction to AI Reconciliation and its Purpose
• Roles and Permissions
• View and Access AI Reconciliation Reports
• Review AI Reconciliation Reports findings
• Manage AI Reconciliation Reports features, and
• Configure AI Reconciliation Reports for Event Analysis Mapping and Lab Measurements

Clinical Data Studio: Cross Study Analytics for Data Quality Management

Overview:

In this course, you will learn about:

• The purpose and value of Cross Study Metrics
• Roles and Access Rights
• Navigation to Cross-Study Dashboards, and
• Understanding the Data in the Dashboards

Data Surveillance: Monitor Critical Study Data

Overview:

In this course, you will learn about:

• Introduction to Data sets and Listings
• View and Manage Data Sets
• How to Create Listings and Submit Rave Queries
• Manage Listings
• How to Create Listings Template
• How to Add and Manage Vendor Queries, and
• Listing Manager

Medidata Clinical Data Studio December 2024 Release Training

Overview:

The Medidata Clinical Data Studio December 2024 release includes:

1) Data Connect

• Dataset Activation
• Data Profiling
• SDTM Dataset Generation
• Improved Dataset Page
• Enhanced Enriched View/Unit Conversion
• Field Transformation
• Third-party EDC data imports
• Direct Connect with an external EDC vendor

2) Data Surveillance

• Patient Profile Comments
• Patient Milestones for third party
• TSDV counts in Clean Patient Tracker
• Published audit datasets are available in Listings and Data Sets
• UI/UX enhancements of the Clean Patient Tracker

3) RBQM

• Audit Trail Review
• Integrated Data Quality Plans
• Review process when creating Issues
• Improved risk level view
• Enhanced Actions and Mitigations Documentation

4) Cross Study Analytics

• Cross Study Metrics for KRIs, QTLs, and Clean Patients

Data Surveillance: Manage Patient Data Using Clean Patient Tracker

Overview:

The course has been updated to reflect December 2024 Release features and enhancements. The feature enhancements such as TSDV counts in the tracker, enhanced UI/UX of the Clean Patient Tracker, and missing pages from Rave for Clean Patient Tracker.

RBQM: Analyze Data Using Statistical Monitoring

Overview:

The course has been updated to reflect UI updates and updates to the issue creation process.

New Name: RBQM: Monitor Risk

Previous Name: RBQM: Monitor Risk Using Risk Management

Overview:

In this course, you will learn:

• Introduction to Risk Assessment and Risk Inventory
• Navigate to Risk Assessment
• Add and Manage Critical Data
• Add and Manage Risks
• Add and Manage Critical Processes
• Review the list of risks in Risk Inventory
• Generate and Manage QTL Summary Report; and
• Add and Manage Plan Documents

New Name: Data Surveillance: Design Patient Profiles

Old Name: Data Surveillance: Build Patient Profiles Overview

Overview:

The course has been updated to reflect:

• How to Preview and Publish Draft Patient Profiles Designs,
• How to Manage Published Patient Profiles, and
• How to Review and Download Patient Profiles

Rave CTMS 2024.6.0 Release Training

Overview:

This training covers key enhancements necessary to implement and support Rave CTMS successfully for R12. The course is beneficial to Medidata Rave CTMS configuration teams and end users. Additional information can be found in the release newsletter.

New Name: 

Data Connect: Restructure and Standardize Data Using Transformations

Old Name:

Data Connect: Transform and Standardize Data Using Transformations

Overview:

In this course, you will learn about:

• Introduction to Transformations
• Roles and Permissions
• Navigate Transformations
• How to Create a Derived Dataset Project
• How to Create a Unit Conversion Project
• How to Create a Custom Data Model, and
• How to Manage a Transformation Project 

Data Connect: Ingest Third-Party Data Using Imports

Overview:

In this course, you will learn about:

• Imports in Data Connect
• How to Add Data Sources
• How to Add Datasets and Import Data
• How to Activate Imported Datasets
• How to Review and Manage Imports 

Old Name:

User Management in Medidata Imaging

New Name: 

User Management in Rave Imaging

Overview:

This 12-minute eLearning covers Managing Roles, Managing Users, Importing

User Roles and Mappings, and Task Pools in Rave Imaging. This training is intended for administrator users who will need to add and/or manage users in Rave Imaging.

Old Name :

Reviewer Specifics in Medidata Imaging

New Name:

Reviewer Specifics in Rave Imaging

Overview:

This 8-minute eLearning covers how to access and complete tasks in Rave Imaging. This training is intended for users who will complete Reviewer tasks in Rave Imaging.

How to Create Transposed Tables

Overview:

The video has been updated to reflect December 2024 release features and enhancements.

How to Preview and Publish A Patient Profile

Overview:

The video has been updated to reflect December 2024 release features and enhancements.

How to Start Creating a Patient Profile

Overview:

The video has been updated to reflect December 2024 release features and enhancements.

Configure and Utilize Custom Fields

Overview:

How to Configure and Utilize Custom Fields for use in Operation Data within Rave CTMS

Data Surveillance: Build Patient Profiles

Overview:

Patient Profiles are configurable templates used to design and display patient level data using study environment-specific metadata. Patient Profiles provides the ability to generate data reporting documentation based on profile designs for various clinical trial roles, such as data managers or site managers, to review and interpret study data, or to submit data to regulatory authorities.

This course provides an in-depth look at the Patient Profiles tool, including detailed workflows and best practices for building profiles.