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rSDV for rSDV Specialists

Course Name: 

rSDV for rSDV Specialists

 

Course Duration:

12 Hours

CEU Credits:

1.2 CEUs

 

Instructor:

rSDV Course Instructor

 

Course Description:

Remote Source Document Verification (rSDV) is the process of remotely comparing and verifying data collected during clinical trial research.  It is a comparison of the data present in case report forms (CRFs) with source document data to verify the information was entered accurately.  This course will provide learners with the tools and knowledge to proficiently verify data for clinical trial research. In this course, through a combination of lecture, tutorials, and hands-on activities, the participant learn to use both the Inspire EDC and I-Vault eTMF  systems to validate clinical trial data and to fire queries for issue notification.

 

Course Prerequisites:

  • Proficient in Microsoft Excel
  • Basic computer and internet navigation skills
  • Able to navigate Windows efficiently
  • Able to retrieve email attachments and save them to a location on the computer
  • Successful  completion of PharmaVigilant Introduction and Overview
  • Successful completion of InSpire
  • Successful completion of I-Vault

Maximum Number of Attendees:

Instructor-Led classroom: 10

 

Course Objectives:

  • Upon completing the course, the learner will be able to:
  • Set up and share dual computer screens
  • Successfully navigate between dual internet browser windows
  • Explain the rSDV process
  • Compare and validate data between EDC and eTMF systems
  • Access and analyze rSDV reports
  • Fire queries with the appropriate query reasons
  • Promote a form to SDV Reviewed
  • Lock a document
  • Resolve and Approve a query

Learning Expectations:

  • Participants will work on a training version of the actual InSpire and I-Vault systems to fully understand the process of rSDV.
  • Participants will also complete activities and tutorials designed to facilitate learning.

Assessment:

  • Learners will be assessed at the conclusion of the course:
  • A written, multiple choice exam is administered.
  • A pass rate of 90% is required for successful completion.
  • Participant must attend 100% of the course to receive full CEU credits.
  • Missed content can be completed within one week of the originally scheduled course. 
  • Completion of the Course and Instructor Evaluation form is required at course end.

Certificate/ CEU

A Certificate of Completion containing the number of CEU's earned will be issued at the successful passing of course. 

 

Learner Support:

Questions may be directed to:
PVU Administrator
Phone: (508) 475-4202
Fax: (508) 898-0005

 

Learning Facility Address:

Will be provided

 

Required Documents:

Completed Registration form

 



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