Clincapture Training - Study Workflow

11 Questions | Total Attempts: 136

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Clincapture Training - Study Workflow - Quiz

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Questions and Answers
  • 1. 
    How does an Investigator know that there are eCRFs ready to be signed?
    • A. 

      A. The subject record in the Subject matrix will have a Sign icon on the far right of the record

    • B. 

      B. The study Monitor or Sponsor will provide you a list of the subjects

    • C. 

      C. eCRFs needing signature can only be seen using a separate application

    • D. 

      D. The CRC will need to manually create/maintain a list of subjects needing signatures

  • 2. 
    Reason for Change is required when...
    • A. 

      Any updates are made to a saved CRF

    • B. 

      Performing Source Data Verification

    • C. 

      Data is changed by someone other than the person who originally entered the data

    • D. 

      Updates are made after the eCRF has been marked complete

  • 3. 
    Clinical Research Coordinators are expected to respond to all discrepancies with a status of:
    • A. 

      Closed

    • B. 

      New

    • C. 

      Updated by DM

    • D. 

      Updated by CRC

  • 4. 
    A Site Monitor can perform data review, source data verification, and issue queries in ClinCapture.
    • A. 

      True

    • B. 

      False

  • 5. 
    ClinCapture provides several built in data validation checks for common data entry errors.  They include: (check all that apply)
    • A. 

      Required field (asterisk)

    • B. 

      Date format (dd-mmm-yyyy)

    • C. 

      Out of range check

    • D. 

      No built in data checks are available

  • 6. 
    In EDC you may have more than one Role in a study. Which of the following would not be allowed?
    • A. 

      A. Clinical Research Coordinator at two sites

    • B. 

      B. Clinical Research Coordinator at one site and Administrator at another site

    • C. 

      C. Principal Investigator at one site and Clinical Research Coordinator at another site

    • D. 

      D. Clinical Research Associate at all sites

  • 7. 
    The User Audit Trail allows you to see when a user was accessing the system.
    • A. 

      True

    • B. 

      False

  • 8. 
    When a user is deleted from the system all data they entered is permanently deleted.
    • A. 

      True

    • B. 

      False

  • 9. 
    ClinCapture does not support Double Data Entry.
    • A. 

      True

    • B. 

      False

  • 10. 
    If the PI will not be available to eSign the Casebook, they may designate another user to sign on their behalf. The designated user must have the role of:
    • A. 

      Data Manager

    • B. 

      Study Monitor

    • C. 

      Main CRC

    • D. 

      Study Coder

    • E. 

      Investigator

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