Clincapture Training - Introduction

1. After successful login to ClinCapture EDC, your active Study and/or Site is displayed:

In the Message Section of the screen.

In the Notification Section of the screen.

On the bottom right of the page.

On the top left of the page above the metrics Dashboard

Study Name and Protocol ID are displayed at the top left of ClinCapture EDC to ensure all users are working in the proper study.

Explanation

Study Name and Protocol ID are displayed at the top left of ClinCapture EDC to ensure all users are working in the proper study.

2. The Study Name and Unique Protocol ID are used to:

A. Identify the Study in ClinCapture EDC, as displayed on the top of every screen

B. Must be unique for each study created

C. Can be changed after the study has been moved to Production

D. Both A and B

Study Name and Protocol ID must be unique and are displayed at the top of ClinCapture EDC to ensure all users are working in the proper study.

Explanation

Study Name and Protocol ID must be unique and are displayed at the top of ClinCapture EDC to ensure all users are working in the proper study.

3. The user profile is where an individual can reset their password, set their time zone, and change their email address.

True

False

User can manage their personal settings on the Profile page by clicking on their username in the upper right corner. Usernames cannot be changed once assigned.

Explanation

User can manage their personal settings on the Profile page by clicking on their username in the upper right corner. Usernames cannot be changed once assigned.

4. After successful login to ClinCapture EDC, your active Study and/or Site is displayed:

In the Message Section of the screen.

In the Notification Section of the screen.

On the bottom right of the page.

On the top left of the page above the metrics Dashboard

Study Name and Protocol ID are displayed at the top left of ClinCapture EDC to ensure all users are working in the proper study.

Explanation

Study Name and Protocol ID are displayed at the top left of ClinCapture EDC to ensure all users are working in the proper study.

5. The user profile is where an individual can reset their password, set their time zone, and change their email address.

True

False

User can manage their personal settings on the Profile page by clicking on their username in the upper right corner. Usernames cannot be changed once assigned.

Explanation

User can manage their personal settings on the Profile page by clicking on their username in the upper right corner. Usernames cannot be changed once assigned.

6. The typical sequence for Event Status (Visits) in the subject casebook are:

Not Started, Scheduled, Data Entry Started, Completed, Source Data Verified, Signed, Locked

Double Data Entry, Data Entry Started, Completed, Signed, Source Data Verified

Locked, Scheduled, Completed, Source Data Verified, Signed

Completed, Scheduled, Signed, Source Data Verified, Locked

Events may have a number of statuses but there is a workflow in ClinCapture EDC that requires the events to progress in order: Not Started, Scheduled, Data Entry Started, Completed, Source Data Verified, Signed, Locked

Explanation

Events may have a number of statuses but there is a workflow in ClinCapture EDC that requires the events to progress in order: Not Started, Scheduled, Data Entry Started, Completed, Source Data Verified, Signed, Locked

7. Which Roles can Deploy a study from Studio to EDC?

A. Owner

B. Sponsor

C. Collaborator

D. Viewer

E. All of the above

F. Both A and B

Only the Owner and Sponsor are allowed to deploy a study. Collaborators and Viewers cannot deploy studies.

Explanation

Only the Owner and Sponsor are allowed to deploy a study. Collaborators and Viewers cannot deploy studies.

8. Where can system help be found?

A. Under Tasks -> Help in ClinCapture EDC

B. Under the training menu in ClinCapture Studio

C. On the ClinCapture Community website

D. All of the above

All of the choices allow you to access various modes of help for using ClinCapture.

Explanation

All of the choices allow you to access various modes of help for using ClinCapture.

9. To quickly find a specific subject, you should: (mark all that apply)

Filter the Subject Matrix using the subject identifier column

Navigate to the Subject by using the Search box in the upper right corner

Delete all other subjects

Call the Study Admin when you need to find a single subject

Finding a single subject in a large study can be done both by filtering the Subject Matrix and searching for a subject using the Search field.

Explanation

Finding a single subject in a large study can be done both by filtering the Subject Matrix and searching for a subject using the Search field.

Submit

10. How can I share my study, so my team can assist with the creation of eCRFs?

A. Click on the study tile, then choose share

B. Calling support over the telephone to provide sharing details

C. On the study tile, click the person silhouette, then choose share

D. Both A and C

Sharing allows you to invite other users to participate in your CRF design and review. Clicking anywhere on the study tile will allow you to access the Share menu.

Explanation

Sharing allows you to invite other users to participate in your CRF design and review. Clicking anywhere on the study tile will allow you to access the Share menu.

11. ClinCapture Studio and ClinCapture Community share the same account credentials (username/password).

True

False

You can use the same credentials (username and password) in both ClinCpature Studio and ClinCapture Community. Only ClinCapture EDC will have a separate username and password based on your role in the EDC system.

Explanation

You can use the same credentials (username and password) in both ClinCpature Studio and ClinCapture Community. Only ClinCapture EDC will have a separate username and password based on your role in the EDC system.

12. You have not previously logged into ClinCapture EDC and your User name and Password are not working. What should you do?

A. Use the Forget Password link

B. Contact your Study administrator to confirm your credentials and/or have them reset your password

C. Try various username and password combinations until the system gives up and grants you access

D. Use your colleagues credentials

After your first login you will be able to reset your password yourself based on your username and secret question. If you have not already logged on to set your secret question, you will need to contact the Study Admin to assist with a password reset.

Explanation

After your first login you will be able to reset your password yourself based on your username and secret question. If you have not already logged on to set your secret question, you will need to contact the Study Admin to assist with a password reset.

13. After adding a Subject to ClinCapture EDC, the Event status for each event will be:

Either Scheduled or Not Started

Scheduled

Not Started

Casebook Created

Events for the subject will be pre-created based on the configuration for your study including any scheduled dates that were predefined.

Explanation

Events for the subject will be pre-created based on the configuration for your study including any scheduled dates that were predefined.

14. You realize that you entered the wrong chart into the ClinCapture EDC casebook. What should you do?

Go into each eCRF and delete the data, then save the blank eCRFs

From the Subject Matrix, delete the eCRFs.

Contact your Study Administrator or CRA to delete the incorrect data.

Change the subject number to reflect the correct data chart

The Study Admin and CRA can assist with removing incorrectly entered eCRFs. It is never advised to modify the subject number as it may affect other numbers assigned by the system. Leaving blank eCRFs will display incorrect data entry status and metrics.

Explanation

The Study Admin and CRA can assist with removing incorrectly entered eCRFs. It is never advised to modify the subject number as it may affect other numbers assigned by the system. Leaving blank eCRFs will display incorrect data entry status and metrics.

15. When adding a subject to ClinCapture EDC...

A. You can create the subject and jump directly to data entry.

B. You must schedule all Events/Visits before accessing data entry.

C. You must return to the Subject Matrix before starting data entry.

D. None of the above

To speed up subject creation you can use the buttons when creating a subject to add the subject and go right to data entry without needing to return to the Subject Matrix to schedule the events.

Explanation

To speed up subject creation you can use the buttons when creating a subject to add the subject and go right to data entry without needing to return to the Subject Matrix to schedule the events.

16. Hovering on the Event Icon in the Subject Matrix, will always display the eCRFs for that event/visit.

True

False

eCRFs that are part of the event are only displayed when the Event has been scheduled.

Explanation

eCRFs that are part of the event are only displayed when the Event has been scheduled.