July 2024 Medidata Global Education Monthly Course Digest

Rave Site Cloud: End of Study (Client Coordinators)

Objective:

In this course, you will learn about the Client Coordinator role, and the various tasks they can perform.

After completing this course, you will be able to:

• Identify the role of a client coordinator
• Create and submit site instructions
• Generate a report for site instructions
• Update and resubmit site instructions 

Rave Site Cloud: End of Study - Tasks for Administrators

Overview:

In this course, you will learn about the role of a client coordinator along with the tasks they perform in Site Cloud: End of Study.

After completing this course, you will be able to:

• Transfer EOS media from the FTP server
• View EOS Media transferred from Rave PDF Generator
• Generate the EOS Import Report
• Set up users and workflows,
• Manage Access Rights and Workflow Maintenance
• Archived EOS studies
• Regrant site users access to archived studies 

Site Monitoring: Study Environment Level Settings

Overview:

Site Monitoring provides efficient monitoring of clinical studies with integrated workflows to improve the site monitor experience, aid proactive decision making, and reduce risk and costs to ultimately increase study performance, patient safety, and time to market for the drug or device. This course focuses on how to configure Site Monitoring settings at the Study environment level.

Topics covered include:

• Access Study Environment Level Settings
• Copy Client Division Level Settings
• Create Visit Schedules
• Configure Study Sites Settings
• Configure Report Settings 

Date of Retirement Announcement: Aug 5, 2024

Official Date of Retirement: September 25, 2024

Medidata Site Monitoring: Visit Management

Overview:

Site Monitoring provides efficient monitoring of clinical studies with integrated workflows to improve the site monitor experience, aid proactive decision making, and reduce risk and costs to ultimately increase study performance, patient safety, and time to market for the drug or device. This course outlines the process of manually adding and conducting visits in Site Monitoring.

In this course, you will learn about:

• Accessing Site Monitoring
• Adding a Monitoring Visit
• Conducting a Monitoring Visit

Date of Retirement Announcement: Aug 5, 2024

Official Date of Retirement: September 25, 2024

Site Monitoring: Client Division Level Settings

Overview:

Site Monitoring provides efficient monitoring of clinical studies with integrated workflows to improve the site monitor experience, aid proactive decision making, and reduce risk and costs to ultimately increase study performance, patient safety, and time to market for the drug or device. This course focuses on how to configure Site Monitoring settings at the Client Division level.

Topics covered include:

• Configuration of Visit Types and Conduct Methods
• Configuration of Visit Activities and Questions
• Configuration of Risk Categories
• Configuration of Visit Matrix
• Configuration of Visit Report Templates
• Configuration of Visit Letter Templates

Date of Retirement Announcement: Aug 5, 2024

Official Date of Retirement: September 25, 2024

Rave Companion: Working with Rave Forms and Medidata Health Record Connect.

Overview:

This eLearning has been updated with the new feature enhancements for showing and filtering data, and flagging PHI data, as per the Rave Companion 2024.2.0  release.

Rave Companion: Working with Rave Forms

Overview:

This eLearning has been updated with the new feature enhancements for flagging PHI data, as per the Rave Companion 2024.2.0  release.

Medidata.com

Introduction to Extractor

Overview:

• Overview of MEDS Extractor
• Creating and Scheduling Export Jobs
• Downloading Data Extracts
• Manage Export Jobs, and
• SFTP for Data Extracts

Topics covered in- Data Connect: Extract Data Using Exports

Date of Retirement Announcement: Aug 5, 2024

Official Date of Retirement: February 5, 2025 

Extractor for Administrators

Overview:

• Creating and using an SFTP location, and
• Creating and using an Amazon S3 location
• Topics Covered in - Data Connect: Configuring Delivery Locations for Data Exports

Topics covered in- Data Connect: Configuring Delivery Locations for Data Exports

Date of Retirement Announcement: Aug 5, 2024

Official Date of Retirement: February 5, 2025 

Medidata Rave eTMF: Reports

Overview:

The Rave eTMF feature of Rave RCM is a content management system that stores, organizes, and secures documents, images, and other digital content for pharmaceutical clinical trials that can be required for compliance with government regulatory agencies. In this course, you will learn about the different reports you can access in Rave eTMF.

In this course, you will learn about:

• How different roles use e.T.M.F reports
• The purpose of each e.T.M.F report
• Report Management

Medidata Site Monitoring: Submit, Review and Approve Visits

Overview:

Site Monitoring provides efficient monitoring of clinical studies with integrated workflows to improve the site monitor experience, aid proactive decision making, and reduce risk and costs to ultimately increase study performance, patient safety, and time to market for the drug or device. This course focuses on submitting, reviewing, and approving the visit reports.

Topics covered include:

• Preview and Submit Visit Reports
• Review and Comment on Visit Reports
• Reject and Resubmit Visit Reports
• Approve Visit Reports 

Date of Retirement Announcement: Aug 5, 2024

Official Date of Retirement: September 25, 2024

Medidata Site Monitoring: Confirmation and Follow Up Letters

Overview:

Site Monitoring provides efficient monitoring of clinical studies with integrated workflows to improve the site monitor experience, aid proactive decision making, and reduce risk and costs to ultimately increase study performance, patient safety, and time to market for the drug or device.

This course covers the workflow for confirmation and follow up letters during site visits.

Topics include:

• Editing and Finalizing Confirmation Letters
• Editing and Finalizing Follow Up Letters 

Date of Retirement Announcement: Aug 5, 2024

Official Date of Retirement: September 25, 2024

Show and Filter EHR Data in Rave Companion

Overview:

This video has been updated to reflect the new enhancements to the Show and Filter functionality, as per the Rave Companion 2024.2.0  release.

Collect Form Data with Rave Companion

Overview:

This video has been updated to reflect the new enhancement for flagging PHI in Rave Companion, as per the 2024.2.0  release.

Best Practices: Rave Labs

Overview:

This course has been adapted to be compatible to deliver for both Rave EDC as well as Classic Rave URLs. 

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.