Clincapture Training - Rules And Sites

1. When using Rule Studio to create rules, it is important to remember to always Save the Rule after it Validates

True

False

It is always important to Validate then Save each rule to check that it can execute before saving it to run against data entry.

Explanation

It is always important to Validate then Save each rule to check that it can execute before saving it to run against data entry.

2. When a Soft Check executes, the user may:

A. Use the flag to address the Discrepancy right away and save again

B. Correct the data and save again

C. Save the data and respond to the Discrepancy at a later time

D. All of the above

Users have three options when entering data that triggers a soft check: fix the data, address the discrepancy directly, or respond to the discrepancy later.

Explanation

Users have three options when entering data that triggers a soft check: fix the data, address the discrepancy directly, or respond to the discrepancy later.

3. Hard Checks may be 'over-ridden' by the user, by clicking on the Flag icon, and providing the reason for the data anomaly.

True

False

Users have the ability to override Hard Checks by clicking on the Flag icon and providing a reason for the data anomaly. This suggests that the statement is true and users have the option to flag and explain any inconsistencies they may come across during the checking process.

Explanation

Users have the ability to override Hard Checks by clicking on the Flag icon and providing a reason for the data anomaly. This suggests that the statement is true and users have the option to flag and explain any inconsistencies they may come across during the checking process.

4. Changing the settings for a Hard Check requires an update to the CRF and a new version to be published.

True

False

Changing the settings for a Hard Check requires an update to the CRF and a new version to be published. This implies that modifying the settings for a Hard Check is not a simple or immediate process. It suggests that any changes made to the settings of a Hard Check would require updating the CRF (Clinical Research Form) and publishing a new version of it. Therefore, the statement is true as it highlights the additional steps and effort involved in changing the settings for a Hard Check.

Explanation

Changing the settings for a Hard Check requires an update to the CRF and a new version to be published. This implies that modifying the settings for a Hard Check is not a simple or immediate process. It suggests that any changes made to the settings of a Hard Check would require updating the CRF (Clinical Research Form) and publishing a new version of it. Therefore, the statement is true as it highlights the additional steps and effort involved in changing the settings for a Hard Check.

5. The Manage Rules interface allows you to:

A. Create rules, Import rules from Excel, Test rules

B. Create rules, Delete or Remove rules, Import rules from XML, Test Rules

C. Import Rules from Excel, Test Rules, Change rule logic

D. Rename or Copy rules

The Manage Rules interface allows you to create rules, delete or remove rules, import rules from XML, and test rules. This means that you can both create and edit rules, as well as import rules from an XML file. Additionally, you have the ability to test the rules to ensure they are functioning correctly. The option to delete or remove rules suggests that you can also manage and remove rules that are no longer needed.

Explanation

The Manage Rules interface allows you to create rules, delete or remove rules, import rules from XML, and test rules. This means that you can both create and edit rules, as well as import rules from an XML file. Additionally, you have the ability to test the rules to ensure they are functioning correctly. The option to delete or remove rules suggests that you can also manage and remove rules that are no longer needed.

6. When you create a rule in Rule Studio, it will by default execute on all eCRF versions and all Events where the eCRF exists.

True

False

Rules default to all versions and events where that eCRF is used. You can edit a rule to attach it to a specific event or version only after validating and saving the rule.

Explanation

Rules default to all versions and events where that eCRF is used. You can edit a rule to attach it to a specific event or version only after validating and saving the rule.

7. When using conditions in Rule Studio (And or Or), parenthesis must be used on either side of the condition (e.g. (A=B) and (C>D))

True

False

Parenthesis are required to ensure proper order of operation. Comparisons should happen before conditions so the comparisons need to happen within a set of parenthesis.

Explanation

Parenthesis are required to ensure proper order of operation. Comparisons should happen before conditions so the comparisons need to happen within a set of parenthesis.

8. A rule with action type of email:

A. Can be defined to send to one or more recipients

B. Will only send an email

C. Will both send an email and display a message on the eCRF

D. Is not a supported function of ClinCapture

A rule with an action type of email will both send an email and display a message on the eCRF. This means that when the rule is triggered, it will not only send an email to the designated recipients but also display a message on the electronic case report form (eCRF) for the relevant users to see. This allows for effective communication and notification within the system itself, ensuring that all relevant parties are informed about the triggered rule.

Explanation

A rule with an action type of email will both send an email and display a message on the eCRF. This means that when the rule is triggered, it will not only send an email to the designated recipients but also display a message on the electronic case report form (eCRF) for the relevant users to see. This allows for effective communication and notification within the system itself, ensuring that all relevant parties are informed about the triggered rule.

9. The logic of a Soft Check may be changed...

A. Anytime.

B. Only before go-live;

C. At the end of the study;

D. None of the above.

Soft checks can be edited at any time using the Rule Studio and tested on @Build before being copied to Production.

Explanation

Soft checks can be edited at any time using the Rule Studio and tested on @Build before being copied to Production.

10. When adding a rule to a live study, or changing rule logic it is always advised to immediately:

A. Only let the new/updated rule execute on new data entered after the new/updated rule

B. Execute the rule, so it may be executed on data already in the Database

C. Test the rule prior to executing the rule against production data

D. All of the above

Testing all rules ensure the study design performs as expected and intended to collect your study data. Once you have created or changed the rule, you can use the Test Module to check rule performance or use @Build to test the rule using data entry.

Explanation

Testing all rules ensure the study design performs as expected and intended to collect your study data. Once you have created or changed the rule, you can use the Test Module to check rule performance or use @Build to test the rule using data entry.

11. Subject Groups (cohorts, arms) may be used to:

Keep visits grouped together in the Subject Matrix

Allow for protocol variations based on study structure

Allow for protocol specific visit structures

Collect additional metadata used for Subject Matrix display and included in exports

Subjects can be assigned and managed in groups when working with the Subject Matrix and Data Extracts.

Explanation

Subjects can be assigned and managed in groups when working with the Subject Matrix and Data Extracts.

12. When creating Sites:

Each site may allow for customized Event and eCRF behavior

All site settings must match throughout the study

Sites will inherit Event eCRF settings

None of the above

During site creation the new site will inherit the Event eCRF settings but will allow customizations specific to each site.

Explanation

During site creation the new site will inherit the Event eCRF settings but will allow customizations specific to each site.

Submit

13. Which of the following are true when utilizing Groups: (mark all that apply)

New Subject Groups may be added in the Update Study Subject Details page

Based on a study configuration setting, they will be editable or non-editable

Manual groups may be assigned at the time a Subject is added

Randomization Groups may be assigned automatically based on the result of the randomization allocation

Subject groups are configured during the study design and may be editable if configured in the study settings. ClinCapture supports both manual assignment during subject creation and automatic assignment during subject randomization.

Explanation

Subject groups are configured during the study design and may be editable if configured in the study settings. ClinCapture supports both manual assignment during subject creation and automatic assignment during subject randomization.

Submit