Clincapture Training - Ecrf Design
This ClinCapture Training on eCRF Design assesses skills in creating and managing electronic Case Report Forms. Key areas tested include the use of Studio Libraries, handling PHI data, session management, form design considerations, and implementing Skip Logic in ClinCapture EDC.
- 1.
Type description here
- 2.
Type description here
- 3.
Studio Libraries are a feature that allow you to: (mark all that apply)
- A.
Copy eCRFs from studies shared with you
- B.
Copy eCRFs from the CDISC CDASH Library
- C.
Copy eCRFs from any sponsor using ClinCapture
Correct Answer(s)
A. Copy eCRFs from studies shared with you
B. Copy eCRFs from the CDISC CDASH LibraryExplanation
Users can copy from libraries provided by ClinCapture (CDISC CDASH), any study the user created, and from any study which has been shared with the user. Users cannot copy from a study just because that sponsor is using ClinCapture.Rate this question:
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- 4.
When designing an eCRF, the item configuration "Contains Personal Health Information (pHI) data", is used to:
- A.
Prevent the data export of the data in the field
- B.
Indicate that the field has PHI data during a data export
- C.
Hide the PHI data from the Sponsor
- D.
Import PHI data from the electronic health record
Correct Answer
B. Indicate that the field has PHI data during a data exportExplanation
PHI is an indicator during export for protected/personal health information.Rate this question:
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- 5.
When working in Form studio creating eCRFs, remember to Save often, as the session expiration is set to:
- A.
30 Minutes
- B.
60 Minutes
- C.
4 Hours
- D.
40 Hours
Correct Answer
C. 4 HoursExplanation
Studio sessions expire after 4 hours of inactivity to ensure compliance with 21 CFR Part 11 and other regulatory requirements.Rate this question:
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- 6.
Considerations for designing eCRFs include:
- A.
Sponsor item naming conventions
- B.
Date formats (e.g. full or partial)
- C.
How Checkbox, Radio or List data is stored in the Database
- D.
All of the above
Correct Answer
D. All of the aboveExplanation
CRF designers need to consider all of these when planning their eCRFs as the initial decisions will impact the data stored in the database and in data extracts.Rate this question:
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- 7.
Each eCRF may present the following information at the top of each page:
- A.
CRF Name, Title, Subtitle, and Instructions
- B.
CRF Name, Header, Help text, and Instructions
- C.
Section Name, Title, Help Text, and Footer
- D.
CRF Name, Item level help, Subtitle, Instructions
Correct Answer
A. CRF Name, Title, Subtitle, and InstructionsExplanation
The top of each CRF page can include the Name, Title, Subtitle, and Instructions if the user chooses to complete those fields in Studio.Rate this question:
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- 8.
When utilizing Skip Logic (Simple Conditional Display), the field in ClinCapture EDC is
- A.
Hidden until a previous question is answered with a specific choice
- B.
Used to skip the next page in the event/visit
- C.
Shown until a previous question has certain data
- D.
Shown on a separate page with only one question
Correct Answer
A. Hidden until a previous question is answered with a specific choiceExplanation
Skip Logic will hide a question until a previous question is answered with an expected choice. When displayed it will appear in order on the current page of questions.Rate this question:
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- 9.
While designing an eCRF, any field available on the eCRF or within the user library may be cloned into the eCRF
- A.
True
- B.
False
Correct Answer
A. TrueExplanation
In eCRF design, it is possible to clone any field from the eCRF or the user library into the eCRF. This means that existing fields can be duplicated and used multiple times within the same eCRF or across different eCRFs. Cloning fields can be helpful in situations where similar data needs to be collected or when there is a need to reuse certain fields across different forms. Therefore, the statement "any field available on the eCRF or within the user library may be cloned into the eCRF" is true.Rate this question:
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- 10.
A List field will...
- A.
Display a set of code list values for display only
- B.
Allow the user to select one or more values from a code list
- C.
Require the user to enter a list of values
- D.
None of the above
Correct Answer
B. Allow the user to select one or more values from a code listExplanation
List fields are used to display a code list of one or more items that can be chosen during data entry. List fields support both single-select or multi-select depending on the eCRF configuration settings.Rate this question:
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- 11.
A Radio field will...
- A.
Allow users to select multiple choices
- B.
Display choices on a radio dial
- C.
Allow users only a single choice
- D.
None of the above
Correct Answer
C. Allow users only a single choiceExplanation
Radio fields allow users to select a single choice from a pre-defined code list or dictionary.Rate this question:
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- 12.
A Checkbox field will...
- A.
Present one or more option(s) for the user to choose
- B.
Determine which eCRFs are displayed in the event/visit
- C.
Present only one option to choose
- D.
None of the above
Correct Answer
A. Present one or more option(s) for the user to chooseExplanation
Checkboxes allow the user to select one or more choices from a code list.Rate this question:
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Quiz Review Timeline +
Our quizzes are rigorously reviewed, monitored and continuously updated by our expert board to maintain accuracy, relevance, and timeliness.
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Current Version
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Feb 03, 2023Quiz Edited by
ProProfs Editorial Team -
Jan 12, 2017Quiz Created by
Eric Morrie
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