Rave Study Design and Build Essentials Training Agenda
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1 Training Agenda Approximate Duration: 2 ½-day sessions Rave EDC Essentials 1 Time Topic Session 1 30 min Welcome & Introductions 30 min imedidata Setting up an imedidata account Navigating imedidata as an end user elearning 3 hr EDC Module - CRC Role Task Summaries The Subject Homepage Data Entry and Editing Add a New Subject Standard Forms All field types Viewing the Audit Trail Log Forms Displaying Previous Visit Data Coding Dictionary Data Translating Data Lab Forms/Lab Ranges 2 CRC Exercises Session 2 45 min EDC Module - CRA Role Working with Markings Template Forms Cleaning Data 1 The 1 st day is delivered remotely in 2 ½ day sesions. 2 Lab forms and Lab ranges will only be covered for clients using the Medidata Rave Lab Administration Module. Document Version 3.0 PROPRIETARY LIMITED DISTRIBUTION 1
2 Grid View CRA Exercises 20 min EDC Module - CDM Role Subject Administration and Sharing Coding Options Cleaning Data Disabling Add Events CDM Exercises 15 min EDC Module - PI Role Electronic Signatures PI Exercises 15 min Basic Reports Accessing Reports in EDC Study/Site/Subject Level Reporting 15 min Query Management Searching for Queries Managing Queries 45 minutes imedidata Setting up a study in imedidata Assigning a Site to a Study Assigning a User to a Study Site 15 min Course Wrap Up Questions and Answers Course Evaluation Document Version 1.0 Page 2 of 5
3 Approximate Duration: 4 days Time Topic DAY 2 9:15am - 9:30am 9:30am - 10:30pm Welcome & Introductions imedidata of navigating imedidata as an end user of study, site, and user set up in imedidata Architect Module Introduction to Architect Project Development Process and Terminology Architect Module: ecrf Configuration Creating a Draft Creating Draft Items: Forms 10:30am 10:45am 10:45:am 12:00pm 12:00pm - 1:00pm 1:00pm 5:00pm Break Creating Draft Items: Fields Creating Draft Items: Fields DAY 3 9:15am 12:00pm Creating Draft Items: Folders Creating Draft Items: Matrices Lab Settings Alerts Draft Settings Publish, Push, and Test Subject Fields Configuration Document Version 1.0 Page 3 of 5
4 12:00pm - 1:00 pm 1:00pm - 2:00pm 2:00pm - 3:15pm 3:30pm - 5:00pm Clinical Views Overview Global Library: Introduction Global Library Overview Defining Copy Sources Copying Objects into a Blank Draft Extension Exercises and Extra Practice DAY 4 9:15am 12:00pm 12:00pm - 1:00 pm 1:00pm 5:00pm Architect Module: Data Validations Introduction to Edit Checks Post-fix Notation Configuring Edit Checks Publish-in-Place Architect Module Data Validations (cont d) Configuring Edit Checks (cont d) Introduction to Derivations Configuring Derivations Introduction to Custom Functions DAY 5 9:15am 10:30am 10:45am - 12:00pm 12:00pm 1:00pm Global Library: Additional Topics Copying Data Validations The Edit Check/Derivation Filter for Retesting Building a Global Library Volume Architect Loader Architect Loader Overview Downloading and Editing a Draft Uploading a Draft Document Version 1.0 Page 4 of 5
5 1:00pm 3:00pm 3:00pm - 4:00pm 4:00pm 4:15pm Architect Module: Data Validations (cont d) Extension Exercises and Extra Practice Final Course Assessment Course Wrap Up Questions and Answers Course Evaluation Document Version 1.0 Page 5 of 5
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