Clincapture Training - Close And Archive - Quiz, Flashcards & Trivia

1. The term Lock in ClinCapture EDC, means that the data for the Study, Site, Event, and/or Entire Casebook has been set to Read-only mode

True

False

Any data in a Locked status is read-only an may not be changed. The Study Admin can unlock data if changes are necessary.

Explanation

Any data in a Locked status is read-only an may not be changed. The Study Admin can unlock data if changes are necessary.

2. Annotated CRFs can be downloaded by the Study Admin users.

True

False

The statement indicates that Study Admin users have the ability to download Annotated CRFs. Therefore, the correct answer is True.

Explanation

The statement indicates that Study Admin users have the ability to download Annotated CRFs. Therefore, the correct answer is True.

3. Why would there be open Notes and Discrepancies at the end of a study?

Sites were told to ignore answering hard or soft checks that were no longer being used

Edit checks were added with mid-study changes which generated queries on a withdrawn subject

A note or discrepancy was manually added before Lock.

All of the above

There are a number of reasons that result in open notes and discrepancies. All of those above are possible reasons but will not prevent the study from being locked.

Explanation

There are a number of reasons that result in open notes and discrepancies. All of those above are possible reasons but will not prevent the study from being locked.

4. The Study must be Archived to stop monthly billing.

True

False

Archiving the study will remove all user access to the study and stop monthly billing. Each month is billed in advance on the first day of the month, there are no partial bills for stopping in the middle of the month.

Explanation

Archiving the study will remove all user access to the study and stop monthly billing. Each month is billed in advance on the first day of the month, there are no partial bills for stopping in the middle of the month.

5. Study Admins should download the following items before requesting an Archive (check all that apply)

Subject Casebooks

CDISC ODM Study Definition (XML)

Final data extracts

ClinCapture Community discussion forums

Prior to archiving a study it is recommended that the Study Admin download the Subject Casebooks (with notes, discrepancies, and audit trail), CDISC ODM Study Definition, and final data extracts because the archive process will remove all access to the study and delete the study after 8 weeks. ClinCapture discussion forums are not part of the study and do not need to be downloaded.

Explanation

Prior to archiving a study it is recommended that the Study Admin download the Subject Casebooks (with notes, discrepancies, and audit trail), CDISC ODM Study Definition, and final data extracts because the archive process will remove all access to the study and delete the study after 8 weeks. ClinCapture discussion forums are not part of the study and do not need to be downloaded.

Submit

6. Locked studies are retained indefinitely, even if stop paying monthly subscription fees.

True

False

ClinCapture offers options to retain study data after the study has been locked and archived with ongoing paid subscriptions.

Explanation

ClinCapture offers options to retain study data after the study has been locked and archived with ongoing paid subscriptions.

7. An Event is eligible for Locking:

Once it has been scheduled

When the PI thinks the study coordinator is awesome

When all required eCRFs have been Completed, Source Data Verified, or Signed

None of the above

Locking data requires the eCRFs to be comple.ted and either Source Data Verified and/or Signed depending on the study configuration

Explanation

Locking data requires the eCRFs to be comple.ted and either Source Data Verified and/or Signed depending on the study configuration

8. Where can users download the event statuses?

They are selected on the Subject Matrix

They can be included in a data extract

Event statuses are only visible inside ClinCapture EDC

ClinCapture only provides Subject Status and CRF Status

ClinCapture provides Subject, Event, and CRF statuses which can be included in a data extract for download. Event status icons are visible in EDC but cannot be downloaded from the Subject Matrix.

Explanation

ClinCapture provides Subject, Event, and CRF statuses which can be included in a data extract for download. Event status icons are visible in EDC but cannot be downloaded from the Subject Matrix.

9. Study archives are requested by using the Archive button in ClinCapture Studio.

True

False

The statement is explaining that in order to request study archives in ClinCapture Studio, one must use the Archive button. This implies that the Archive button is the designated function for requesting study archives within the software. Therefore, the correct answer is True.

Explanation

The statement is explaining that in order to request study archives in ClinCapture Studio, one must use the Archive button. This implies that the Archive button is the designated function for requesting study archives within the software. Therefore, the correct answer is True.