Clincapture Training - Close And Archive

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| By Eric Morrie
E
Eric Morrie
Community Contributor
Quizzes Created: 10 | Total Attempts: 1,435
| Attempts: 104
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  • 1/9 Questions

    The term Lock in ClinCapture EDC, means that the data for the Study, Site, Event,  and/or Entire Casebook has been set to Read-only mode

    • True
    • False
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About This Quiz

This ClinCapture Training quiz on 'Close and Archive' assesses knowledge on data locking, event eligibility for locking, handling notes and discrepancies, downloading annotated CRFs, and study archival processes. It prepares learners for effective data management in clinical trials.

Clincapture Training - Close And Archive - Quiz

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  • 2. 

    Annotated CRFs can be downloaded by the Study Admin users.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    The statement indicates that Study Admin users have the ability to download Annotated CRFs. Therefore, the correct answer is True.

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  • 3. 

    Why would there be open Notes and Discrepancies at the end of a study?

    • Sites were told to ignore answering hard or soft checks that were no longer being used

    • Edit checks were added with mid-study changes which generated queries on a withdrawn subject

    • A note or discrepancy was manually added before Lock.

    • All of the above

    Correct Answer
    A. All of the above
    Explanation
    There are a number of reasons that result in open notes and discrepancies. All of those above are possible reasons but will not prevent the study from being locked.

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  • 4. 

    The Study must be Archived to stop monthly billing.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    Archiving the study will remove all user access to the study and stop monthly billing. Each month is billed in advance on the first day of the month, there are no partial bills for stopping in the middle of the month.

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  • 5. 

    Study Admins should download the following items before requesting an Archive (check all that apply)

    • Subject Casebooks

    • CDISC ODM Study Definition (XML)

    • Final data extracts

    • ClinCapture Community discussion forums

    Correct Answer(s)
    A. Subject Casebooks
    A. CDISC ODM Study Definition (XML)
    A. Final data extracts
    Explanation
    Prior to archiving a study it is recommended that the Study Admin download the Subject Casebooks (with notes, discrepancies, and audit trail), CDISC ODM Study Definition, and final data extracts because the archive process will remove all access to the study and delete the study after 8 weeks. ClinCapture discussion forums are not part of the study and do not need to be downloaded.

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  • 6. 

    Locked studies are retained indefinitely, even if stop paying monthly subscription fees.

    • True

    • False

    Correct Answer
    A. False
    Explanation
    ClinCapture offers options to retain study data after the study has been locked and archived with ongoing paid subscriptions.

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  • 7. 

    An Event is eligible for Locking:

    • Once it has been scheduled

    • When the PI thinks the study coordinator is awesome

    • When all required eCRFs have been Completed, Source Data Verified, or Signed

    • None of the above

    Correct Answer
    A. When all required eCRFs have been Completed, Source Data Verified, or Signed
    Explanation
    Locking data requires the eCRFs to be comple.ted and either Source Data Verified and/or Signed depending on the study configuration

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  • 8. 

    Where can users download the event statuses?

    • They are selected on the Subject Matrix

    • They can be included in a data extract

    • Event statuses are only visible inside ClinCapture EDC

    • ClinCapture only provides Subject Status and CRF Status

    Correct Answer
    A. They can be included in a data extract
    Explanation
    ClinCapture provides Subject, Event, and CRF statuses which can be included in a data extract for download. Event status icons are visible in EDC but cannot be downloaded from the Subject Matrix.

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  • 9. 

    Study archives are requested by using the Archive button in ClinCapture Studio.

    • True

    • False

    Correct Answer
    A. True
    Explanation
    The statement is explaining that in order to request study archives in ClinCapture Studio, one must use the Archive button. This implies that the Archive button is the designated function for requesting study archives within the software. Therefore, the correct answer is True.

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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 14, 2017
    Quiz Created by
    Eric Morrie
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