Clincapture Training - Settings And Events

1. When configuring Events the available options include

Common - CRFs not related to a specific event/visit

Scheduled - manually scheduled in an expected sequence

Calendared - automatically scheduled based on a baseline

Unscheduled - CRFs to be completed outside of an expected event/visit

All of the above

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

Explanation

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

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

True

False

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.

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.

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

Locked

Available

Design

Frozen

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

Explanation

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

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

True

False

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.

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.

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

Assigned to the event later in ClinCapture Studio during eCRF creation

Added only for specific subjects

Added only at time of creation

Added at creation or modified later to add eCRFs as needed.

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.

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.

6. ClinCapture EDC System settings:

Can be edited at any time during the study

Apply to all studies on the instance

Are only accessible while at the Study Level

All of the above

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.

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.

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

True

False

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.

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.

8. Visit windows can be configured for your study using:

Common Events

Calendared Events

Scheduled Events

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

Explanation

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

9. Subject identification can be configured to allow

Automatic numbering within each site

Selecting subject ID from a predefined list

Manual entry when adding a new subject

Printed barcode wristbands

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

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

Hide or display based on time of day

Appear in a specific order

Allow end users to repeat an event for unscheduled visits

Allow sites to use multiple versions of each CRF

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.

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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