Contact Us

If you still have questions or prefer to get help directly from an agent, please submit a request.
We’ll get back to you as soon as possible.

Please fill out the contact form below and we will reply as soon as possible.

  • Contact Us
  • Home
  • Helpdesk
  • News
  • Latest news

Changes to data management workflows introduced with CDMS v2024.4.0.0

Contact Us

If you still have questions or prefer to get help directly from an agent, please submit a request.
We’ll get back to you as soon as possible.

Please fill out the contact form below and we will reply as soon as possible.

  • CDMS
    Castor CDMS Manual Castor CDMS Calculations Manual Frequently Asked Questions Articles for Data Managers Castor CDMS Compliance Release Documents
  • eConsent
    Castor eConsent Manual Castor eConsent Compliance Release Documents
  • SMS
    Castor SMS Manual Castor SMS Compliance Release Documents
  • Castor Connect
    Castor Connect Compliance Release Documents Castor Connect Manual Castor Connect - Participant Quick Start Guide
  • Helpdesk
    News Other Resources Castor products knowledge resources
  • Status page
  • Completing a Study
+ More

Table of Contents

Automated (re-)execution of calculations How it works While building a study Validation for cyclic dependencies Restriction on deleting fields During data entry When importing data Enabling the feature for existing studies Automated (re-)evaluation and persistence of validations How it works While building a study During data entry When importing data Enabling the feature for existing studies

With the release of Castor CDMS version 2024.4.0.0 in December 2024, we are introducing two new features to enhance data management workflows: automated (re-)execution of calculations and automated (re-)evaluation and persistence of validations. These features will be automatically enabled for new studies.

This article outlines these features, explains their impact on study building, data entry, and data import, and describes how to enable them in studies created before this update.

 


 

Automated (re-)execution of calculations

Calculation fields are fields that automatically compute and display values based on predefined formulas using data from other fields within a study.

 


This feature ensures that calculations get (re-)executed automatically in the background throughout the data collection process (whenever data are entered or imported) and when there are changes to calculation templates or the study structure. Previously, users had to reopen forms to trigger recalculations, as calculations were only updated on the current form. 

 

How it works

This feature is enabled by default for new studies created after the 2024.4.0.0 release.

 

While building a study

Calculations automatically re-execute in the background for all participants whenever:

  • A calculation field is created, updated, copied, or imported.
  • A form containing a calculation field is created, copied, or imported.

 

If the result of a calculation changes, the updated value is stored similarly to regular data entry and is attributed to a System User. This also applies to changes applied via Form Sync. An event is logged in the Audit Trail, similar to regular data entry events (Participant result, Repeating Data Instance result, Survey result).

 


 

Validation for cyclic dependencies

When saving or importing calculation fields, the system verifies that calculations do not depend on each other in a circular manner, which would prevent execution. If a cyclic dependency is detected, an error message is displayed when the calculation is added.


 

Restriction on deleting fields

Fields used in calculations cannot be deleted. To delete a field that is part of a calculation, the calculation field must be updated or removed first.


 

During data entry

Calculations automatically re-execute in the background for a participant whenever:

  • Values of fields that are part of a calculation are entered or changed.
  • New Repeating Data Instances or Survey Package Instances are created or archived that either:
    • Include fields used in calculations elsewhere.
    • Contain calculation fields themselves.
  • Participants, Visits, Forms, Repeating Data Instances, or Survey Package Instances are unlocked or unarchived when they either:
    • Have fields used in calculations elsewhere.
    • Contain calculation fields themselves.

If the result of a calculation changes, the updated value is stored and attributed to the user performing the data entry. An event is logged in the Audit Trail, similar to regular data entry events (Participant result, Repeating Data Instance result, Survey result).

 


 

When importing data

Calculations automatically re-execute in the background for a participant whenever:

  • Data for fields that are used in a calculation are imported (via CSV or FHIR) or pushed to CDMS through the API. 

 

If the result of a calculation changes, the updated value is stored and attributed to the user performing the import. An event is logged in the Audit Trail, similar to regular data entry events (Participant result, Repeating Data Instance result, Survey result).


 

Enabling the feature for existing studies 

To maintain consistency in the execution of calculations, this feature is not enabled by default for studies created before CDMS version 2024.4.0.0.

 

For existing studies, you can enable this feature on the Study Settings page. When activated on an active study, the automated re-execution of calculations will only occur from the moment it is enabled. Previously calculated values will not be updated upon enabling; they will only be updated when a re-execution is triggered as described above.

 

To enable this feature:

  • Go to the Study Settings page and select the Study properties tab.
  • Check the ‘Enable automated re-execution of calculations’ checkbox.

 

Enabling this feature triggers a validation of all calculation templates in the study to ensure they can execute properly. This validation includes:

  • Checking for circular dependencies between calculations (i.e., verifying that calculations do not reference each other in a loop).
  • Ensuring that all variable names used in calculations resolve correctly.

 

If any invalid calculation templates are found, the feature cannot be enabled. Please review all calculation templates to resolve any issues.

Please note that once enabled, this feature cannot be disabled for your study.

 

 


 

Automated (re-)evaluation and persistence of validations

Validations (also known as system edit checks) notify users about required actions or warn them of potential errors based on the data entered. 

 


This feature ensures that validations are automatically evaluated in the background whenever data is entered or when changes are made to the study structure. It also ensures that the complete history of validations is persistently maintained and can be reviewed in the study's audit trail. Previously, automatically closed validations were no longer visible in the interface.

 

How it works

This feature is enabled by default for new studies created after the 2024.4.0.0 release.

 

While building a study

Validations are automatically (re-)evaluated in the background for all participants whenever:

  • The validation configuration of a field is changed, either by adding, updating, or removing one or more validations.

 

By (re-)evaluating, a validation can either be: 

  • Opened (marked as New): when a condition is met and a validation message should show for a field
    • Example: A warning message is configured to display when a participant's height exceeds 220 cm, and a value of 250 cm is entered. Therefore, a validation is opened.
  • Automatically closed (marked as Auto-closed): when the condition of the validation is not met anymore
    • Example: A warning message is configured to display when a participant's height exceeds 200 cm, and a value of 210 cm is entered. The validation is updated to trigger only when the height exceeds 220 cm. Therefore, the previously opened validation auto-closes.

 

If a validation is opened or automatically closed after re-evaluation, the action is stored and attributed to a System User. This also applies to changes applied via Form Sync. A Validation triggered or Validation status updated event is also logged in the Audit Trail.

 

 

 

During data entry

Validations are automatically (re-)evaluated in the background for a participant whenever:

  • A value is entered or changed of a field that contains a validation.

 

By (re-)evaluating, a validation can either be: 

  • Opened (marked as New): when a condition is met and a validation message should show for a field
    • Example: A warning message is configured to display when a participant's height exceeds 220 cm, and a value of 250 cm is entered. Therefore, a validation is opened.
  • Automatically closed (marked as Auto-closed): when the condition of the validation is not met anymore
    • Example: a warning message is configured to display when a participant's height exceeds 220 cm. A value of 250 cm was previously entered, and the value is corrected to 180 cm. Therefore, the previously opened validation auto-closes.

 

If a validation is opened or automatically closed after re-evaluation, the action is stored and attributed to the user performing the data entry. A Validation triggered or Validation status updated event is also logged in the Audit Trail.

 

 

When importing data

Please note that validations are not automatically being evaluated upon Data Import. We are reviewing options to include this event with future CDMS versions.

 

 

Enabling the feature for existing studies 

To maintain consistency in the validations overview, this feature is not enabled by default for studies created before CDMS version 2024.4.0.0.

 

Enabling this feature on an active study will only retrigger and persist validations from the moment it is activated onward. It does not retroactively retrigger validations or generate a historical record of previously triggered validations. Therefore, to ensure the validations overview remains consistent, existing active studies can enable this feature only by contacting Castor Customer Support.

 

Please note that once enabled, this feature cannot be disabled for your study.

 

 

 

workflows data management validations edit-check

Was this article helpful?

Yes
No
Give feedback about this article

Related Articles

  • Launching Castor eConsent
  • Coming Soon: CastorConnect!
  • FormSync feature
  • Apache Log4j platform impact
  • Upcoming Terminology changes in Castor EDC
ISO 27001
FDA - 21 CFR part 11
ICH GCP compliant
HIPAA compliant
CDISC
ISO 9001
gdpr compliant

Products & Industries

  • Electronic Data Capture (EDC)
  • ePRO
  • eConsent
  • Decentralized Clinical Trials (DCT)
  • Clinical Data Management
  • Medical Device & Diagnostics
  • Biotech & Pharma
  • CROs
  • Academic Research

Resources

  • Thought Leadership
  • Blog
  • Castor Academy
  • Knowledge Base

 

Company

  • About Us
  • Careers
  • News
  • Contact Support
  • Contact Us

Legal & Compliance

  • Terms of Use
  • Privacy & Cookie Statement
  • Responsible Disclosure Policy
  • Good Clinical Practice (GCP)
  • ISO Compliance Certificates
  • GDPR & HIPAA Compliance
  • Security Statement

© 2022, Castor. All Rights Reserved.

Follow us on social media


Knowledge Base Software powered by Helpjuice

Definition by Author

0
0
Expand