Clincapture Training - Ecrf Design

1. Considerations for designing eCRFs include:

Sponsor item naming conventions

Date formats (e.g. full or partial)

How Checkbox, Radio or List data is stored in the Database

All of the above

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.

Explanation

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.

2. When utilizing Skip Logic (Simple Conditional Display), the field in ClinCapture EDC is

Hidden until a previous question is answered with a specific choice

Used to skip the next page in the event/visit

Shown until a previous question has certain data

Shown on a separate page with only one question

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.

Explanation

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.

3. While designing an eCRF, any field available on the eCRF or within the user library may be cloned into the eCRF

True

False

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.

Explanation

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.

4. Studio Libraries are a feature that allow you to: (mark all that apply)

Copy eCRFs from studies shared with you

Copy eCRFs from the CDISC CDASH Library

Copy eCRFs from any sponsor using ClinCapture

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.

Explanation

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.

Submit

5. A Checkbox field will...

Present one or more option(s) for the user to choose

Determine which eCRFs are displayed in the event/visit

Present only one option to choose

None of the above

Checkboxes allow the user to select one or more choices from a code list.

Explanation

Checkboxes allow the user to select one or more choices from a code list.

6. A List field will...

Display a set of code list values for display only

Allow the user to select one or more values from a code list

Require the user to enter a list of values

None of the above

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.

Explanation

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.

7. A Radio field will...

Allow users to select multiple choices

Display choices on a radio dial

Allow users only a single choice

None of the above

Radio fields allow users to select a single choice from a pre-defined code list or dictionary.

Explanation

Radio fields allow users to select a single choice from a pre-defined code list or dictionary.

8. Each eCRF may present the following information at the top of each page:

CRF Name, Title, Subtitle, and Instructions

CRF Name, Header, Help text, and Instructions

Section Name, Title, Help Text, and Footer

CRF Name, Item level help, Subtitle, Instructions

The top of each CRF page can include the Name, Title, Subtitle, and Instructions if the user chooses to complete those fields in Studio.

Explanation

The top of each CRF page can include the Name, Title, Subtitle, and Instructions if the user chooses to complete those fields in Studio.

9. When working in Form studio creating eCRFs, remember to Save often, as the session expiration is set to:

30 Minutes

60 Minutes

4 Hours

40 Hours

Studio sessions expire after 4 hours of inactivity to ensure compliance with 21 CFR Part 11 and other regulatory requirements.

Explanation

Studio sessions expire after 4 hours of inactivity to ensure compliance with 21 CFR Part 11 and other regulatory requirements.

10. When designing an eCRF, the item configuration "Contains Personal Health Information (PHI) data", is used to: