Clincapture Training - Settings And Events

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| By Eric Morrie

Eric Morrie

Community Contributor

Quizzes Created: 10 | Total Attempts: 1,419

Questions: 10 | Attempts: 143 | Updated: Feb 3, 2023

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Questions and Answers

1.

ClinCapture EDC System settings:
- A.
  
  Can be edited at any time during the study
- B.
  
  Apply to all studies on the instance
- C.
  
  Are only accessible while at the Study Level
- D.
  
  All of the above
Correct Answer
D. All of the above

Explanation
System settings apply to all studies on the instance (URL) and can be edited at any time. The system settings will not be available when at the Site Level.

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2.

When Lockout Enabled is set to True the system lock the user account after the specified number of bad password attempts.
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
When the "Lockout Enabled" setting is set to True, it means that the system has a security feature that will lock the user account after a certain number of unsuccessful password attempts. This is a common practice to protect against unauthorized access and brute-force attacks. Therefore, the given answer of True is correct.

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3.

To configure Study specific settings, the Set Study Status should be set to:
- A.
  
  Locked
- B.
  
  Available
- C.
  
  Design
- D.
  
  Frozen
Correct Answer
C. Design

Explanation
The study needs to be in the Design status to make changes to study settings and configuration items (events, groups, etc).

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4.

Subject identification can be configured to allow
- A.
  
  Automatic numbering within each site
- B.
  
  Selecting subject ID from a predefined list
- C.
  
  Manual entry when adding a new subject
- D.
  
  Printed barcode wristbands
Correct Answer(s)
A. Automatic numbering within each site
C. Manual entry when adding a new subject

Explanation
ClinCapture EDC supports automatic numbering and manual entry when adding a new subject. One option can be selected in the Study Settings.

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5.

When configuring Events the available options include
- A.
  
  Common - CRFs not related to a specific event/visit
- B.
  
  Scheduled - manually scheduled in an expected sequence
- C.
  
  Calendared - automatically scheduled based on a baseline
- D.
  
  Unscheduled - CRFs to be completed outside of an expected event/visit
- E.
  
  All of the above
Correct Answer
E. All of the above

Explanation
The four types of events include: Common, Unscheduled, Scheduled, and Calendared.

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6.

When creating Events (visits), the eCRFs for the event may be:
- A.
  
  Assigned to the event later in ClinCapture Studio during eCRF creation
- B.
  
  Added only for specific subjects
- C.
  
  Added only at time of creation
- D.
  
  Added at creation or modified later to add eCRFs as needed.
Correct Answer
D. Added at creation or modified later to add eCRFs as needed.

Explanation
Event eCRFs are configured in ClinCapture EDC, not in Studio. The specific eCRFs for each event can be added at time of creation or later as needed.

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7.

Source Data Verification settings must be configured at the event level to be available to the Study Monitors.
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
In order for the Study Monitors to have access to the Source Data Verification settings, these settings must be configured at the event level. This means that the settings need to be specifically set up for each event within the study. If the settings are not configured at the event level, they will not be available to the Study Monitors. Therefore, the statement is true.

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8.

Events (Visits) can be configured to: (mark all that apply)
- A.
  
  Hide or display based on time of day
- B.
  
  Appear in a specific order
- C.
  
  Allow end users to repeat an event for unscheduled visits
- D.
  
  Allow sites to use multiple versions of each CRF
Correct Answer(s)
B. Appear in a specific order
C. Allow end users to repeat an event for unscheduled visits
D. Allow sites to use multiple versions of each CRF

Explanation
During event creation users can specify both the visit order as well as allow repeating events for unscheduled visits. Events can support a single eCRF version or allow multiple versions where they end user will select the appropriate version to complete at time of data entry. ClinCapture does not support time of day limits on events.

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9.

Visit windows can be configured for your study using:
- A.
  
  Common Events
- B.
  
  Calendared Events
- C.
  
  Scheduled Events
Correct Answer
B. Calendared Events

Explanation
Calendared Events will support creation of a baseline reference event and visit windows for expected, earliest, and latest visit dates.

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10.

Hiding a CRF at the Event configuration only allows the Site to see that CRF.
- A.
  
  True
- B.
  
  False
Correct Answer
B. False

Explanation
Hiding a CRF at the Event configuration prevents sites from using that CRF. This may be useful for CRFs that the Study Admin will maintain such as lab data loads, protocol deviations, or data review progress.

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Clincapture Training - Settings And Events

ClinCapture EDC System settings:

When Lockout Enabled is set to True the system lock the user account after the specified number of bad password attempts.

To configure Study specific settings, the Set Study Status should be set to:

Subject identification can be configured to allow

When configuring Events the available options include

When creating Events (visits), the eCRFs for the event may be:

Source Data Verification settings must be configured at the event level to be available to the Study Monitors.

Events (Visits) can be configured to: (mark all that apply)

Visit windows can be configured for your study using:

Hiding a CRF at the Event configuration only allows the Site to see that CRF.