Clincapture Training - Module 2

1. 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.

2. 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.

3. 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

4. How does an Investigator know that there are eCRFs ready to be signed?

A. The subject record in the Subject matrix will have a Sign icon on the far right of the record

B. The study Monitor or Sponsor will provide you a list of the subjects

C. eCRFs needing signature can only be seen using a separate application

D. The CRC will need to manually create/maintain a list of subjects needing signatures

A user can have either a Study level role or a Site level role, but not both. Study level roles include Administrator, Monitor, Coder, Evaluator. Site level roles include Investigator, Clinical Research Coordinator, and Site Monitor.

Explanation

A user can have either a Study level role or a Site level role, but not both. Study level roles include Administrator, Monitor, Coder, Evaluator. Site level roles include Investigator, Clinical Research Coordinator, and Site Monitor.

5. 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.

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6. A Site Monitor can perform data review, source data verification, and issue queries in ClinCapture.

True

False

A Site Monitor is responsible for reviewing data, verifying the source data, and addressing any issues or queries that arise in ClinCapture. This indicates that the statement "A Site Monitor can perform data review, source data verification, and issue queries in ClinCapture" is true.

Explanation

A Site Monitor is responsible for reviewing data, verifying the source data, and addressing any issues or queries that arise in ClinCapture. This indicates that the statement "A Site Monitor can perform data review, source data verification, and issue queries in ClinCapture" is true.

7. 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.

8. ClinCapture provides several built in data validation checks for common data entry errors. They include: (check all that apply)

Required field (asterisk)

Date format (dd-mmm-yyyy)

Out of range check

No built in data checks are available

ClinCapture provides required field, range, and date format checks to prevent data entry errors. Users can click on the Flag icon for each question to provide an override reason if necessary.

Explanation

ClinCapture provides required field, range, and date format checks to prevent data entry errors. Users can click on the Flag icon for each question to provide an override reason if necessary.

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9. 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.

10. 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.

11. Reason for Change is required when...

Any updates are made to a saved CRF

Performing Source Data Verification

Data is changed by someone other than the person who originally entered the data

Updates are made after the eCRF has been marked complete

Regardless of who originally entered the data, a reason for change is always required once the eCRF has been marked complete.

Explanation

Regardless of who originally entered the data, a reason for change is always required once the eCRF has been marked complete.

12. Clinical Research Coordinators are expected to respond to all discrepancies with a status of:

Closed

New

Updated by DM

Updated by CRC

Both New and Updated by DM discrepancies are waiting for the Clinical Research Coordinator or Investigator response. Queries that were Updated by CRC/PI or have been Closed are not waiting for the site to respond.

Explanation

Both New and Updated by DM discrepancies are waiting for the Clinical Research Coordinator or Investigator response. Queries that were Updated by CRC/PI or have been Closed are not waiting for the site to respond.

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13. Match the Source Data Verification levels available in ClinCapture with their activity descriptions.

All questions included in the eCRF must be compared to the original source documents for completeness and accuracy.

Specific questions will need to be source data verified to support risk-based monitoring or less than 100% SDV.

No questions are required to be verified. This is often used for survey data and subjects who have withdrawn.

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