Clincapture Training - Study Workflow

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| By Eric Morrie
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Eric Morrie
Community Contributor
Quizzes Created: 10 | Total Attempts: 1,435
| Attempts: 191
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  • 1/11 Questions

    How does an Investigator know that there are eCRFs ready to be signed?

    • A. The subject record in the Subject matrix will have a Sign icon on the far right of the record
    • B. The study Monitor or Sponsor will provide you a list of the subjects
    • C. eCRFs needing signature can only be seen using a separate application
    • D. The CRC will need to manually create/maintain a list of subjects needing signatures
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About This Quiz

This ClinCapture Training quiz on Study Workflow assesses knowledge on eCRF signing, data validation, and discrepancy management. It is designed for clinical research coordinators and investigators, focusing on practical skills essential for effective study management.

Clincapture Training - Study Workflow - Quiz

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  • 2. 

    ClinCapture does not support Double Data Entry.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    ClinCapture includes feature for electronic data entry, double data entry, and evaluation entry.

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  • 3. 

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

    • True

    • False

    Correct Answer
    A. True
    Explanation
    The User audit trail keeps track of both login and logout date and time to check when an individual account may have had access to the secure system.

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  • 4. 

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

    • True

    • False

    Correct Answer
    A. False
    Explanation
    Data is never deleted from the system to conform to regulations. Users can be marked as removed which essentially deactivates their account.

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  • 5. 

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

    • True

    • False

    Correct Answer
    A. True
    Explanation
    A Site Monitor is responsible for reviewing data, verifying the source data, and raising queries in ClinCapture. This implies that the statement is true, as it accurately describes the role and responsibilities of a Site Monitor in the ClinCapture system.

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  • 6. 

    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:

    • Data Manager

    • Study Monitor

    • Main CRC

    • Study Coder

    • Investigator

    Correct Answer
    A. Investigator
    Explanation
    Only users assigned to the Investigator role are able to sign subject casebooks.

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  • 7. 

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

    • Required field (asterisk)

    • Date format (dd-mmm-yyyy)

    • Out of range check

    • No built in data checks are available

    Correct Answer(s)
    A. Required field (asterisk)
    A. Date format (dd-mmm-yyyy)
    A. Out of range check
    Explanation
    ClinCapture provides required field, range, and date format checks to prevent data entry errors. Users can click on the Flag icon for each question to provide an override reason if necessary.

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  • 8. 

    Reason for Change is required when...

    • Any updates are made to a saved CRF

    • Performing Source Data Verification

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

    • Updates are made after the eCRF has been marked complete

    Correct Answer
    A. Updates are made after the eCRF has been marked complete
    Explanation
    Regardless of who originally entered the data, a reason for change is always required once the eCRF has been marked complete.

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  • 9. 

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

    • A. Clinical Research Coordinator at two sites

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

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

    • D. Clinical Research Associate at all sites

    Correct Answer
    A. B. Clinical Research Coordinator at one site and Administrator at another site
    Explanation
    A user can have either a Study level role or a Site level role, but not both. Study level roles include Administrator, Monitor, Coder, Evaluator. Site level roles include Investigator, Clinical Research Coordinator, and Site Monitor.

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  • 10. 

    Clinical Research Coordinators are expected to respond to all discrepancies with a status of:

    • Closed

    • New

    • Updated by DM

    • Updated by CRC

    Correct Answer(s)
    A. New
    A. Updated by DM
    Explanation
    Both New and Updated by DM discrepancies are waiting for the Clinical Research Coordinator or Investigator response. Queries that were Updated by CRC/PI or have been Closed are not waiting for the site to respond.

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Quiz Review Timeline (Updated): Feb 3, 2023 +

Our quizzes are rigorously reviewed, monitored and continuously updated by our expert board to maintain accuracy, relevance, and timeliness.

  • Current Version
  • Feb 03, 2023
    Quiz Edited by
    ProProfs Editorial Team
  • Jan 03, 2017
    Quiz Created by
    Eric Morrie
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