Clincapture Training - Study Workflow

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| By Eric Morrie

Eric Morrie

Community Contributor

Quizzes Created: 10 | Total Attempts: 1,419

Questions: 11 | Attempts: 191 | Updated: Feb 3, 2023

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Questions and Answers

1.

How does an Investigator know that there are eCRFs ready to be signed?
- A.
  
  A. The subject record in the Subject matrix will have a Sign icon on the far right of the record
- B.
  
  B. The study Monitor or Sponsor will provide you a list of the subjects
- C.
  
  C. eCRFs needing signature can only be seen using a separate application
- D.
  
  D. The CRC will need to manually create/maintain a list of subjects needing signatures
Correct Answer
A. A. The subject record in the Subject matrix will have a Sign icon on the far right of the record

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.

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2.

Reason for Change is required when...
- A.
  
  Any updates are made to a saved CRF
- B.
  
  Performing Source Data Verification
- C.
  
  Data is changed by someone other than the person who originally entered the data
- D.
  
  Updates are made after the eCRF has been marked complete
Correct Answer
D. Updates are made after 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.

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3.

Clinical Research Coordinators are expected to respond to all discrepancies with a status of:
- A.
  
  Closed
- B.
  
  New
- C.
  
  Updated by DM
- D.
  
  Updated by CRC
Correct Answer(s)
B. New
C. Updated by DM

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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4.

A Site Monitor can perform data review, source data verification, and issue queries in ClinCapture.
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
A Site Monitor is responsible for reviewing data, verifying the source data, and raising queries in ClinCapture. This implies that the statement is true, as it accurately describes the role and responsibilities of a Site Monitor in the ClinCapture system.

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5.

ClinCapture provides several built in data validation checks for common data entry errors. They include: (check all that apply)
- A.
  
  Required field (asterisk)
- B.
  
  Date format (dd-mmm-yyyy)
- C.
  
  Out of range check
- D.
  
  No built in data checks are available
Correct Answer(s)
A. Required field (asterisk)
B. Date format (dd-mmm-yyyy)
C. Out of range check

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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6.

In EDC you may have more than one Role in a study. Which of the following would not be allowed?
- A.
  
  A. Clinical Research Coordinator at two sites
- B.
  
  B. Clinical Research Coordinator at one site and Administrator at another site
- C.
  
  C. Principal Investigator at one site and Clinical Research Coordinator at another site
- D.
  
  D. Clinical Research Associate at all sites
Correct Answer
B. B. Clinical Research Coordinator at one site and Administrator at another site

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.

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7.

The User Audit Trail allows you to see when a user was accessing the system.
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
The User audit trail keeps track of both login and logout date and time to check when an individual account may have had access to the secure system.

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8.

When a user is deleted from the system all data they entered is permanently deleted.
- A.
  
  True
- B.
  
  False
Correct Answer
B. False

Explanation
Data is never deleted from the system to conform to regulations. Users can be marked as removed which essentially deactivates their account.

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9.

ClinCapture does not support Double Data Entry.
- A.
  
  True
- B.
  
  False
Correct Answer
B. False

Explanation
ClinCapture includes feature for electronic data entry, double data entry, and evaluation entry.

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10.

If the PI will not be available to eSign the Casebook, they may designate another user to sign on their behalf. The designated user must have the role of:
- A.
  
  Data Manager
- B.
  
  Study Monitor
- C.
  
  Main CRC
- D.
  
  Study Coder
- E.
  
  Investigator
Correct Answer
E. Investigator

Explanation
Only users assigned to the Investigator role are able to sign subject casebooks.

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Clincapture Training - Study Workflow

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

Reason for Change is required when...

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

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

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

In EDC you may have more than one Role in a study. Which of the following would not be allowed?

The User Audit Trail allows you to see when a user was accessing the system.

When a user is deleted from the system all data they entered is permanently deleted.

ClinCapture does not support Double Data Entry.

If the PI will not be available to eSign the Casebook, they may designate another user to sign on their behalf. The designated user must have the role of: