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Medidata RTSM Course-Catalog Roadmap

Medidata RTSM Course-Catalog Roadmap

Use this roadmap to find the Medidata Academy courses you can take to learn about RTSM functionality.

Phase 1 – The Rave EDC module that Rave RTSM is integrated with.

Phase 2 – Randomization and treatment design.

Phase 3 – Logistics for supply managers, shippers and sites.

Phase 4Manage studies after its live

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PHASE 1

Learn about the Rave EDC application Medidata Rave RTSM communicates with.

  • What is Rave EDC?
  • What subject information is captured in Rave EDC?

Courses:

This eLearning will demonstrate how to use Rave EDC during a study. The course will show how to access Rave EDC, navigate and view data, queries and the audit trail.

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PHASE 2

Learn how to

  • Randomize subjects
  • Assign treatments to subjects
  • Assign treatments to subjects in a cohort study

Courses:

  • Getting Started with Medidata RTSM  (~ 15 min):
    This eLearning will cover the basics of RTSM, such as the life cycle overview, how RTSM integrates with iMedidata and Medidata EDC, the study setup wizard, and the impact of roles and permissions.
  • Medidata Rave RTSM: Randomization Design (~18 min):
    This eLearning will demonstrate how to design a randomization plan and execute simulations. Please note that Cohorts and Treatment Periods will be covered in separate courses.
  • Medidata Balance Randomization Design and Simulations (4 hours):
    This instructor-led training will focus on creating and configuring trial simulations for a study using pre-validated randomization methods. Please note that Cohorts and Treatment Periods will be covered in separate course.
  • Medidata Rave RTSM: Cohorts Overview (~15 min):
    This eLearning course will demonstrate how to set up a cohort-enabed study and how to design cohorts within a cohort study.
  • Medidata Rave RTSM: Managing Cohort Factors (~8 min)
    This eLearning course will cover how cohort factors help build cohort inclusion rules so that Rave RTSM can randomize a subject into a cohort.
  • Medidata Balance Re-Randomization / Multiple Treatment Periods (~16 min):
    This eLearning will cover how to create multiple treatment periods in the same study, and re-randomize move subjects linearly through treatment periods.
  • Medidata Balance Unblinding (5 min):
    For those who have access to unblind, this eLearning will cover how to unblind subjects during a study.
  • Medidata Rave RTSM: Treatment Design (16 min):
    This eLearning is intended for Rave RTSM users who has access to create article types, treatment compositions, dosing factors, and setting up titration rules in the Design tab. You will also learn how to set up a treatment schedule based on the treatment design.

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PHASE 3

Learn how to

  • Review the trial supply management process
  • Manage trial and individual site inventories
  • Manage inventory with supply accountability
  • Manage pooling groups at depots or sites

Courses:

  • Medidata Rave RTSM: Getting Started with Trial Supply Management (~8 min):
    This eLearning will introduce how trial supplies are managed and monitored in Rave RTSM. The course will demonstrate how the study design determines when and how much inventory should be at the study site and depot, as well as how Rave RTSM generates email alerts to the appropriate receiver.
  • Medidata Rave RTSM: Trial Supply Management (~4 hours):
    This instructor-led training is recommended for Study Managers, Study Designers, Project Managers, CRA, Monitors, Supply Managers, Shipping Managers, and Depot Project Managers. Through a mock study, the instructor will briefly go over how the Randomization Design affects how trial supplies management process, then will go over more in-depth discussion and hands-on exercises relating to creating supply plans, activating supply depots and study sites for shipping, uploading an inventory list, analyzing the inventory overview screens, and reviewing the shipment process.
  • Medidata Rave RTSM: Managing Supply Plans (~19 min):
    This course is intended for Rave RTSM supply managers who have the ability to create and manage supply plans for study sites. The eLearning will go over how to create and modify a Buffer Only Supply Plan, Predictive Only Supply Plan, and Predictive and Buffer Supply Plan. It will also go over the supply plan options, such as creating Decoy groups and setting the supply plan as the default supply plan for all sites associated to a study.
  • Medidata Rave RTSM: Managing Sites, Depots, and Lot (~20 min)
    This course is intended for supply managers who will be assigning study sites to inventory depots, setting up lot information at depot locations, and reviewing inventory at specific locations.
  • Medidata Rave RTSM: Logistics for Shippers (~16 min):
    This eLearning will cover inventory management and generation of shipments of study supplies.
  • Medidata Rave RTSM: Logistics for Site Users (~6 min):
    This eLearning will cover how site users can confirm the receipt of inventory items at investigative sites.
  • Medidata Rave RTSM: Shipping to Return Depot and Destroying items at Destruction Sites (~10 min):
    This eLearning is intended for Study Managers and Site users who mark inventory for return and create/manage shipments to return depots. This course will also cover how to destroy items at designated destruction sites.
  • Medidata Rave RTSM: Pooling Supplies at Depots and Sites (~11 min):
    This eLearning will cover how to create pooling groups to share inventory between studies with common article types and matching depots/sites.
  • Medidata Rave RTSM: Supply Accountability Overview (~17 min):
    This eLearning will cover how Supply Accountability is defined at the article type level, how it is monitored through Dispensation in Rave EDC, and how supply accountability is reconciled at the site. This course will also go over the related Supply Accountability reports.
  • Medidata Rave RTSM: Identifying Supply Accountability Inventory for Destruction (~17 min):
    This eLearning will cover how Supply Accountability items are marked for destruction at either destruction sites, or sent to destruction depots. We will also review the Supply Accountability Destruction history.
  • Medidata Rave RTSM: Inspecting Destruction Shipments with Supply Accountability (~10 min):
    This eLearning will cover how destruction shipments with Supply Accountability items arrive at a destruction depot, and how to confirm the contents of the shipment in Rave RTSM.

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PHASE 4

Learn how to 

  • Manage studies after its live

Courses:

  • Medidata Rave RTSM: Edit Live Design (~10 min):
    This eLearning will cover how authorized users can edit a live study. Please note that this does not apply to cohort or treatment period studies.