Clincapture Training - Study Workflow

1. ClinCapture does not support Double Data Entry.

True

False

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

Explanation

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

2. 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.

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

True

False

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.

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.

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

True

False

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

Explanation

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

5. 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 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.

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.

6. 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:

Data Manager

Study Monitor

Main CRC

Study Coder

Investigator

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

Explanation

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

7. 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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8. 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.

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

A. Clinical Research Coordinator at two sites

B. Clinical Research Coordinator at one site and Administrator at another site

C. Principal Investigator at one site and Clinical Research Coordinator at another site

D. Clinical Research Associate at all sites

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.

10. 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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11. 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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