Änderungsprotokoll

v2.17.0 (2025-08-18) Minor

Features

• Expression enhancements
  • Added a new environment variable to expressions, allowing fields to be hidden based on whether forms are answered in the app or survey.
  • Added a new getParameter function to expressions, allowing access to URL parameters for dynamic form behavior or data retrieval.
  • Besides the existing floor and ceil functions, added a new round function for rounding to the nearest whole number.
  • Calculations can now be of type Preload (in accordance with CDISC ODM MethodDef) to calculate a field value only once and prevent it from being overwritten when form data changes.

Improvements

• Added text align justify option to documents and descriptive texts which is also supported in PDF/A exports.

Bug fixes

• Solved an error that prevented users from unselecting a date value by clicking on the same day in the calendar again.
• Fixed an issue where conditional fields in the application settings were sometimes not rendered correctly.

v2.16.1 (2025-08-14) Patch

Improvements

• Added border and center options to the Likert scale field for improved visual customization.

Bug fixes

• Fixed an issue where the button group field sometimes did not reflect data updates.

v2.16.0 (2025-08-13) Minor

Features

• Likert scales
  • OpenEDC now provides a dedicated Likert scale field type, complete with a simple and interactive editor.
  • Visually, a Likert scale is similar to a data matrix (introduced in v2.0.0), but offers a streamlined creation process.
  • From a technical perspective, Likert scales are grouped items, enabling multiple Likert scales within one form section.
  • This technical foundation opens up possibilities for future multidimensional data collection fields, such as coordinate systems.
  • Likert scales are fully supported in PDF/A exports for robust and long-term and archival.
• Recode and average functions
  • Added new recode function to remap coded values of multiple fields using a dictionary, enabling complex data transformations in calculations.
  • Added new average function to calculate average values across multiple fields.
  • These functions work seamlessly together to calculate scores for psychological questionnaires and scoring systems (e.g., SF-36).

Improvements

• To help distinguish between different types of validation, permissive (soft) validation messages are now displayed in blue, while strict (hard) rule violations remain in red.
• Improved performance when loading forms with many expressions that require data from other forms by fetching items in a batch.
• Active quick filters in lists are now highlighted in blue for better recognizability.

Bug fixes

• Fixed an issue where the form status could erroneously switch to Complete if a repeating section (with more than one instance) contained unanswered mandatory fields.
• Corrected a bug where removing a codelist item (i.e., a single- or multiple-choice option) sometimes didn’t work when using the backspace key.
• Solved a data export error in Chrome by requesting the directory handle before data fetch operations that could invalidate the user interaction context.
• Resolved a permission issue where project owners with minimal rights were not able to update project settings.
• Fixed two issues with conditions that sometimes prevented them from working in surveys or when referencing event names.

v2.15.2 (2025-07-28) Patch

Improvements

• Custom fields with codelist items (introduced in v2.12.0) are now rendered as quick filters in the subject list by default.

Bug fixes

• Fixed a bug since Chrome and Edge 137 (June 2025) where creating a new codelist item in the form editor sometimes caused the cursor to move up instead of down.
• Custom fields in documents or descriptive fields that evaluate to a numeric zero (0) are now rendered correctly.

v2.15.1 (2025-07-24) Patch

Improvements

• Improved the positioning and spacing of headings and lists in PDF/A exports.
• New study events are now always added to the last study event group for better organization.
• The select field dropdown menu now covers the entire width of the field.

Bug fixes

• Date and time fields that included descriptions were sometimes not properly aligned.

v2.15.0 (2025-07-23) Minor

Features

• Queries in CDISC ODM and PDF/A exports
  • Queries can now be exported to, and imported from, CDISC ODM-XML files.
  • Exports include the entire history of each query, with all comments and state changes.
  • For PDF/A exports, queries are added to an item’s audit table to provide a holistic overview.

Improvements

• When exporting a report table that has file columns, it’s now possible to export all included files as a directory.

v2.14.0 (2025-07-18) Minor

Features

• Expressions in validation rules
  • Custom conditional expressions can now be used in data validation rules.
  • This allows for complex comparisons with previous values or functions (e.g., to ensure a date is not in the future).
  • Furthermore, it is now possible to define custom and localized error messages for more precise user information.

Improvements

• Start and end of line anchors in regular expression validations are now appended implicitly, simplifying the process.

v2.13.1 (2025-07-15) Patch

Improvements

• Repeating event, form, and section instance numbers are now rendered more consistently.
• The study protocol and event groups have been added to the audited data models.

Bug fixes

• Document updates are now rendered correctly when only the name of the document is changed.
• Fixed an issue where query updates that only contained a comment but no data change were not rendered.

v2.13.0 (2025-06-26) Minor

Features

• Redesigned documents
  • The document editor now supports text alignment and tables.
  • A new fixed inline menu is always reachable at the top of a draft document.
  • Documents can now be exported to PDF/A, including text alignment, tables, images, lists, and more.
• Expressions in documents
  • It’s now possible to add arbitrary expressions to documents and descriptive texts.
  • Expressions can pipe in previously entered (clinical) data or perform calculations.
  • New functions in expressions help to format dates and numbers into localized values.
  • Conditional sections in documents can be hidden based on previous inputs.

Improvements

• Custom fields are now rendered for events and forms when available.
• In addition to fields, sections, forms, and visits, study event groups can now be re-ordered via drag-and-drop.

v2.12.0 (2025-06-07) Minor

Features

• Custom fields in subject list and table
  • You can now display any form field as a custom value in the subject list and table.
  • Subjects can be filtered and sorted by these custom fields.
  • The default subject creation date can be hidden if desired.
  • This enables use cases such as adding a custom subject status or displaying an alternative date field.

Improvements

• For fields in expressions (conditions and calculations), the event name is now shown if it’s different from the current one.
• Added custom step intervals for numeric inputs (integer and decimal), as well as for the range slider.
• The aggregated subject form status now renders more granular values instead of 20% steps.
• Numeric fields now use region-specific decimal separators in reports and exports.

Bug fixes

• Temporarily disabled the automated inactivity logout during large data imports to prevent interruptions.
• Improved the handling of conditional forms in repeating events.
• The completion progress for optional events is now shown without influencing the aggregated subject status.

v2.11.0 (2025-05-26) Minor

Features

• Delete form data
  • For each subject, a new menu option allows you to delete all data and the status of a selected form.
  • For repeating forms, the selected instance will also be removed.
  • Deletion requires permission and is recorded in the audit trail.
• Required two-factor authentication
  • The owner of a project can now mandate two-factor authentication (2FA) for all users.
  • If a user without 2FA enabled attempts to access such a project, they will see an error with an option to enable it.

Improvements

• When a form is unselected from all events in the assignment table, an error message now prevents losing the reference to it.
• Improved the performance of file uploads, downloads, and previews.

v2.10.0 (2025-05-19) Minor

Features

• Sortable subject list
  • Subjects in the list view can now be sorted by their creation date in either ascending or descending order.
  • Additionally, the list’s sort, filter, and search states are now persisted between navigations and reloads.

Improvements

• Subjects can now be filtered by their status: incomplete, complete, verified, or locked.

v2.9.0 (2025-05-16) Minor

Features

• PDF export and print functionalities now support including the audit trail.

Improvements

• Improved and extended the help documentation, especially for data management topics.
• In addition to events, forms can now also be marked as optional, which influences status aggregation.
• Added list and table virtualization for improved performance when rendering thousands of subjects.

v2.8.1 (2025-04-11) Patch

Improvements

• The guided CSV import now supports multiple-choice data that is comma-separated.
• The CSV import now also supports repeating events, forms, and sections.

v2.8.0 (2025-04-07) Minor

Improvements

• File uploads are now resumable, show upload progress, and support files of up to 5 GB.
• The form header now supports custom image uploads and is resizable.

Bug fixes

• During a CSV import, the mapping of default fields sometimes did not work reliably.

v2.7.4 (2025-03-23) Patch

Improvements

• The range slider field now supports the decimal data type, which is useful for things like percentage values.

Bug fixes

• For timezones behind UTC, plain dates were sometimes rendered with a negative offset of one day.
• When auto-incremented keys were enabled, the subject slide-over wasn’t shown, even when a user was assigned to multiple locations.

v2.7.3 (2025-01-24) Patch

Improvements

• Enhanced the performance and user interface of the form versioning dialog.
• Icons are now hosted with the app to improve performance through regional hosting.

Bug fixes

• You will now be correctly redirected to a subject from a scheduled event calendar entry.

v2.7.2 (2024-12-29) Patch

Bug fixes

• The item question of relative paths in conditions will now always be rendered.
• Ensured that zeros are considered as a value in comparative expressions.
• When opening a form from a query, the affected field will now be scrolled into view.

v2.7.1 (2024-12-21) Patch

Improvements

• Made performance improvements for queries.

Bug fixes

• Forms are now hidden in the status overview for users without edit or view permissions.
• The “add event” button is now hidden for users without editing permissions.

v2.7.0 (2024-12-20) Minor

Features

• Form status overview
  • The subjects module now offers a tabular overview of all form status values: incomplete, complete, verified, locked, and skipped.
  • When clicking on any status, a slide-over appears for data entry or editing.
  • When visits or events are enabled, grouping headers visually join all forms from one event.
  • Fixed headers and the subject key column allow for precise identification even when scrolling in large tables.
  • Header sorting options allow you to sort by subject key, recruitment date, and location.
  • New repeating instances for events and forms are rendered dynamically.

v2.6.1 (2024-12-20) Patch

Bug fixes

• When clicking on the top right arrow within a query, not only the event but also the corresponding form will now be opened.
• On a CDISC ODM import, data UUIDs will now be replaced to ensure uniqueness.
• When creating a new form draft, multiple references to the same code list are no longer duplicated.
• In conditions with boolean operators, numeric values are no longer compared using lexicographical order.

v2.6.0 (2024-12-06) Minor

Features

• Pie chart
  • A new pie chart can now be added to custom reports to visualize the ratio of categorical values.
  • A chart-based filter can now be deselected by simply clicking on the value again.
• Role and permission matrix
  • Roles and their assigned permissions can be viewed and edited in a tabular overview for improved clarity.
  • Two new default roles were added for study nurses and data managers.
• Date binning in charts
  • It’s now possible to group date values by year, month, day, or weekday in categorical charts (e.g., bar or pie charts).
  • Binned values can be used as live filters (e.g., showing subjects recruited in a specific year, month, or a combination of both).

Improvements

• The date picker now also supports the time-only data type.

v2.5.3 (2024-11-18) Patch

Improvements

• Authorized users may now withdraw their own signatures.
• Based on locations and permissions, only relevant users are displayed in the list of responsible people for a query.

v2.5.2 (2024-11-17) Patch

Improvements

• The form lock state can now be set independently from the completion and verification status.
  • This change also fixes an issue where the form status button was disabled for users who had lock-forms permission but not edit-data permission.
• Form signatures are now rendered in the audit trail slide-over within the subjects module.

v2.5.1 (2024-11-12) Patch

Improvements

• The form status aggregation now only considers mandatory events and shows the completion progress as a percentage.
• Improved authentication routing by using One-Time Passwords (OTPs) instead of URLs for invitation and recovery emails.

v2.5.0 (2024-11-03) Minor

Features

• Bulk signatures
  • Users may now sign (and optionally lock) all forms of a given subject or event at once.

Improvements

• For long forms, the footer now floats at the bottom of the screen for quick access to save and close options.
• An error is now shown when a user attempts to assign an already occupied variable name to an element.
• User roles can now be exported and imported in the CDISC ODM format.
• An item may now have multiple validation rules (i.e., range checks) assigned to it.

v2.4.0 (2024-10-23) Minor

Features

• Open and logout (tablet mode) for surveys
  • Surveys can now be opened directly from within the app, which will first log out the current user.
  • After the survey is finished, a link is rendered to redirect the user back to the app, which will require a new login.
  • The redirect search parameter can also be used for custom purposes in self-embedded surveys.
• Study arms
  • Study event groups can now be defined as arms, with customizable and translated descriptions.
  • Subjects must be explicitly assigned to a study arm in order to collect data for that arm.
• Conditional forms
  • In addition to events, sections, and items, conditional expressions can now also be attached to forms.
  • Events and forms with unmet conditions are still rendered in the subjects list but are disabled for editing.
  • A notification is shown for each skipped form, explaining why it has been conditionally disabled.

Improvements

• Implemented batched clinical data persistence for improved performance.

v2.3.0 (2024-10-14) Minor

Improvements

• Range checks can now be defined as “soft” or “hard,” where soft checks only give a warning instead of preventing data from being saved.
• A regular expression can now be specified in the settings to define and constrain the format of manually entered subject keys.
• Added a new permission that is required for a user to be able to delete subjects.
• Support for custom translations has been added via an addTranslationOverwrite() API.
• There is a new option to batch export multiple CSV files, split by event and form.
• A new permission allows forms to be locked independently of their verification status.
• Events can now be used within conditional expressions to hide or show fields based on the current event.
• You can now revoke the verification of item data via the status panel.

Bug fixes

• Inputs in the data matrix are now correctly disabled if a user is missing edit permissions.
• The form status selection is now properly enabled for users with verify and sign permissions.

v2.2.0 (2024-09-23) Minor

Features

• Reuse of codelists
  • The codelist panel now renders previously defined codelists and allows you to reuse them.
  • Codelists are reused by reference rather than by copying them, and the number of references is shown for each codelist.
• File uploads in documents
  • The documents module now allows the upload of files while rendering PDFs, images, and videos.
  • Versioning is supported by uploading new file versions for a specific document.
  • When referenced in forms, supported files are rendered there as well.

Improvements

• Reports and CSV exports now render event and form names in dedicated columns and only include each item once, even if it is referenced in multiple events or forms.

v2.1.0 (2024-09-04) Minor

Features

• Pattern matching
  • For fields with a text data type, a regular expression can be specified to constrain the data input.

Improvements

• Mandatory fields are now clearly labeled in the PDF export.
• Added support for the datetime data type in a data matrix.
• Data matrices are now validated on input and on submit.
• Added abs, date, left, and right functions to the expression parser.

Bug fixes

• Added a missing project field to the compound key path.
• The status for forms with multiple sections is now aggregated properly.
• For autocompletions in expressions, the field list will now be correctly returned for items that do not have a codelist.

v2.0.0 (2024-08-27) Major

Features

• Data matrix
  • Form sections can be enabled as a “data matrix” to render inputs in a tabular view.
  • Repeating sections can dynamically add and delete rows for repeating instances.
  • Subsequent sections with the same or similar questions are merged into one table.
  • When required, a matrix can be temporarily transposed to edit queries and perform SDV.
• Trial protocol PDF export
  • There is a new option to print all events, including all forms of a project.
  • This feature supports repeating events, forms, and sections, even if they are nested.
  • It also supports printing all clinical data for a selected subject.
  • You can now optionally add variable names and coded values to the PDF export.

Improvements

• Compound primary keys
  • Item data and form status models now overwrite existing data on API imports.
  • Data imports are now performed in batches to improve performance.
• Batched transactions
  • Persisting hierarchical data now uses batched database transactions to improve performance.
• Unified CSV and PDF exports
  • In addition to the report module, CSV files can now be downloaded from the export module.
  • In addition to the forms and subject modules, PDF files can now also be downloaded from the export module. This uses the new File System Access API when PDFs for multiple subjects need to be downloaded.

v1.9.5 (2024-08-10) Patch

Improvements

• Single-choice fields can now be visually represented as select or dropdown menus.
• Forms can now be saved with missing mandatory fields when the status is set to “incomplete”.
• The use of special characters and spaces within subject keys is no longer prevented.
• Added support for count() and sum() in calculation and conditional expressions.

Bug fixes

• Fixed accessibility issues with the range slider field on mobile Safari (iPadOS and iOS).

v1.9.4 (2024-08-09) Patch

Improvements

• In addition to events and fields, conditional expressions can now be entered for sections.
• Study events can now be assigned to pre-defined groups (currently general and visits).

v1.9.3 (2024-08-05) Patch

Improvements

• Adding existing forms to an event can now be done via a tabular view, which shows the assignment for all events.

v1.9.2 (2024-08-03) Patch

Improvements

• In addition to forms and sections, events can now be set as repeating.

v1.9.1 (2024-08-02) Patch

Improvements

• Added support for date subtraction, as well as floor() and ceil() functions, in expressions for calculated fields.
• A user’s preferred name and email are now copied when adding a non-centrally managed user to another project.

Bug fixes

• Numeric expression results for calculated fields of the “integer” type are now rounded correctly.
• The translated missing reason is now rendered correctly in forms and reports.

v1.9.0 (2024-07-25) Minor

Features

• Calculated fields
  • Mathematical expressions can now be used to automatically calculate fields (e.g., to calculate the BMI).
  • The expression editor was updated to suggest mathematical operators (such as for add, subtract, multiply, and divide).

Improvements

• Decimal fields are now rendered with two decimal places by default.

v1.8.0 (2024-07-23) Minor

Features

• End-to-end encryption for clinical data
  • Text, date, and signature fields now support end-to-end encryption for protecting personally identifiable information.
  • The encryption uses the PRF extension for Passkeys, enabling biometric encryption via Touch ID, Face ID, or Windows Hello.
  • A hybrid encryption algorithm uses asymmetric and symmetric primitives from the Web Crypto API (RSA-OAEP and AES-GCM), supporting end-to-end encrypted survey and participant data via a public project key.
  • Encrypted data can be viewed after authentication within forms, reports, and the audit trail.

Improvements

• File uploads can now be viewed and downloaded from the audit trail.

v1.7.0 (2024-07-11) Minor

Features

• Metadata versioning
  • Each form / eCRF now either has a version number or is in draft mode. Published forms can no longer be edited without creating a new draft first.
  • When publishing a draft, the system checks already-captured clinical data for compatibility with the new draft and shows errors for any inconsistencies.
• PDF/A export
  • Answered and empty forms, as well as entire events, can now be exported in PDF/A format.
  • The export supports repeating forms and sections, conditions, electronic signatures, descriptive texts including images, and file upload fields.
• Export and import module
  • For data exports, various options to select data are available, such as specific events, forms, locations, documents, and files.
  • When importing CDISC ODM, these options are also available, allowing you to specifically select which data should be imported.
  • Importing CDISC ODM now allows you to merge metadata into an existing project while showing already-existing events and forms.

Improvements

• The eConsent feature now uses metadata versioning to support arbitrary patient information documents, while showing the signed version for each subject.
• Translated conditions are now rendered directly in the editor fields.
• Customizable preset roles with a defined set of initial rights are now available in the user management module.
• The date picker field now supports the datetime data type.

v1.6.0 (2024-06-13) Minor

Features

• Participant app and self-registration
  • Study participants can now register themselves via a survey and then use a mobile web application to answer scheduled events.
  • The mobile application shows current, upcoming, and previous events and allows for editing previously made answers.
  • Participants can use multi-factor authentication and other account-related functionality.
  • The user module was updated to provide quick filters for showing team members or study participants.
  • The user module now shows a default role for participants to select forms that may be viewed or edited.

Improvements

• A missing reason with an optional comment can now be specified for every field in a form at once.
• The query details now automatically scroll to recently made changes to improve collaborative editing.

v1.5.1 (2024-06-04) Patch

Improvements

• Automatically rendered upcoming event periods can now be specifically dated, timed, and persisted per subject.

Bug fixes

• All-day events will now always be rendered before timed events.

v1.5.0 (2024-05-28) Minor

Features

• A new calendar module is available for both collaborative and personal date management, supporting timed and multi-day events.
• You can now schedule events (or visits) with absolute or relative time periods, including the automatic rendering of upcoming events per subject in the calendar and subject modules.

v1.4.1 (2024-04-30) Patch

Improvements

• Network connectivity issues are now caught when submitting clinical data in the subject module and in surveys.

v1.4.0 (2024-04-29) Minor

Improvements

• An automatic inactivity logout feature has been added, which logs out a user after a defined period of inactivity.
• A user’s account will now be automatically locked after a defined number of successive failed authentication attempts.

v1.3.3 (2024-04-27) Patch

Improvements

• The web app now includes an interactive onboarding tour that introduces key features.

Bug fixes

• Expression data for nested conditional fields will now be unset rather than deleted.

v1.3.2 (2024-03-25) Patch

Improvements

• A cryptographic hash has been added to form signatures to securely identify a specific set of values.
• Multi-factor authentication is now allowed when signing forms.

v1.3.1 (2024-03-20) Patch

Improvements

• Significantly improved the performance for loading metadata from the server.

v1.3.0 (2024-03-13) Minor

Features

• There is now a default report to view the audit trail for all audited data models.
• The audit trail has been enabled for metadata and admin data models.

v1.2.0 (2024-03-08) Minor

Features

• Added form signatures with re-authentication to allow users to take legal responsibility for data.

v1.1.0 (2024-03-02) Minor

Features

• Implemented Source Data Verification (SDV) and Missing Reasons (Null Flavors).
• Uploaded files can now be previewed in reports.
• Implicitly given permissions are now shown visually.
• Data read and write permissions can now be specified on a per-form basis.

v1.0.0 (2024-02-27) Major

Initial release