Clincapture Training - Close And Archive | Attempts: 104

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| By Eric Morrie

Eric Morrie

Community Contributor

Quizzes Created: 10 | Total Attempts: 1,419

Questions: 9 | Attempts: 104 | Updated: Feb 3, 2023

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Questions and Answers

1.

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
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
Any data in a Locked status is read-only an may not be changed. The Study Admin can unlock data if changes are necessary.

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2.

An Event is eligible for Locking:
- A.
  
  Once it has been scheduled
- B.
  
  When the PI thinks the study coordinator is awesome
- C.
  
  When all required eCRFs have been Completed, Source Data Verified, or Signed
- D.
  
  None of the above
Correct Answer
C. 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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3.

Why would there be open Notes and Discrepancies at the end of a study?
- A.
  
  Sites were told to ignore answering hard or soft checks that were no longer being used
- B.
  
  Edit checks were added with mid-study changes which generated queries on a withdrawn subject
- C.
  
  A note or discrepancy was manually added before Lock.
- D.
  
  All of the above
Correct Answer
D. 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.

Annotated CRFs can be downloaded by the Study Admin users.
- A.
  
  True
- B.
  
  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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5.

Study archives are requested by using the Archive button in ClinCapture Studio.
- A.
  
  True
- B.
  
  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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6.

Locked studies are retained indefinitely, even if stop paying monthly subscription fees.
- A.
  
  True
- B.
  
  False
Correct Answer
B. 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.

The Study must be Archived to stop monthly billing.
- A.
  
  True
- B.
  
  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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8.

Where can users download the event statuses?
- A.
  
  They are selected on the Subject Matrix
- B.
  
  They can be included in a data extract
- C.
  
  Event statuses are only visible inside ClinCapture EDC
- D.
  
  ClinCapture only provides Subject Status and CRF Status
Correct Answer
B. 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 Admins should download the following items before requesting an Archive (check all that apply)
- A.
  
  Subject Casebooks
- B.
  
  CDISC ODM Study Definition (XML)
- C.
  
  Final data extracts
- D.
  
  ClinCapture Community discussion forums
Correct Answer(s)
A. Subject Casebooks
B. CDISC ODM Study Definition (XML)
C. 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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Current Version
Feb 03, 2023

Quiz Edited by
ProProfs Editorial Team
Jan 14, 2017

Quiz Created by
Eric Morrie

Clincapture Training - Close And Archive

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

An Event is eligible for Locking:

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

Annotated CRFs can be downloaded by the Study Admin users.

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

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

The Study must be Archived to stop monthly billing.

Where can users download the event statuses?

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