Changelog

v2.5.1 (2024-11-12)

Improvements

• The form status aggregation now only considers mandatory events and shows completion progress in percent (#223)
• Improved authentication routing by using One-Time-Passwords (OTPs) instead of URLs for invite and recovery mails (#232)

v2.5.0 (2024-11-03)

Features

• Bulk signatures (#217)
  • Users may now sign (and optionally lock) all forms of a given subject or event

Improvements

• For long forms, the footer now floats at the bottom of the screen for quick access (#208)
• Show an error when attempting to assign an occupied variable name to an element (#213)
• User roles can now be exported and imported in CDISC ODM format (#216)
• An item may now have multiple validation rules (i.e., range checks) assigned (#221)

v2.4.0 (2024-10-23)

Features

• Open and logout (i.e., tablet mode) for surveys (#190)
  • Surveys can now be opened directly from within the app which will logout the current user
  • After the survey is finished, a link is rendered to redirected the user back to the app, requiring a login
  • The redirect search parameter can also be used for custom purposes in self-embedded surveys
• Study arms (#191)
  • Study event groups can now be defined as arms (with customizable translated descriptions)
  • Subjects must be explicitly assigned to a study arm in order to collect data for this arm
• Conditional forms (#202)
  • Besides 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 disabled for editing
  • A notification shows for each skipped form why it has been conditionally disabled

Improvements

• Batched clinical data persistence for improved performance (#200)

v2.3.0 (2024-10-14)

Improvements

• Range checks can now be defined as soft or hard, while soft checks give a warning only instead of preventing data persistence (#181)
• A regular expression can be specified in the settings to define and constrain the shape of manually entered subject keys (#182)
• Added a new permission that is required for a user to be able to delete subjects (#183)
• Support for custom translations via an addTranslationOverwrite() API (#184)
• Option to batch export multiple CSV files, split by event and form (#185)
• A new permission allows forms to be locked independently of the verification status (#186)
• Events can now be used within conditional expressions to hide or show fields based on the current event (#187)
• Allow to revoke the verification of item data via the status panel (#188)

Bug fixes

• Disable inputs in data matrix for missing user edit permissions (a751884)
• Enable form status select for users with verify and sign permissions (3a2aae0)

v2.2.0 (2024-09-23)

Features

• Reuse of codelists (#179)
  • The codelist (i.e., choices) panel now renders previously defined codelists and allows the reuse of them
  • Codelists are reused by reference rather than copy and the number of references is shown for each codelist
• File uploads in documents (#180)
  • 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 (#178)

v2.1.0 (2024-09-04)

Features

• Pattern matching (#177)
  • For fields of data type text, a regular expression can be specified to constrain the data input

Improvements

• Label mandatory fields in PDF export (dd9168e)
• Support for datetime data type in matrix (9a74b37)
• Validate data matrix on input and submit (a5f6995 and 21d08f6)
• Add abs, date, left, and right functions to expression parser (cb36e58 and b6450b5)

Bug fixes

• Add project field to compound key path (959e09e)
• Properly aggregate status for forms with multiple sections (6d090fb)
• For autocompletions in expressions, return field list for items without codelist (7b2ec82)

v2.0.0 (2024-08-27)

Features

• Data matrix (#169 and #171)
  • Form sections can be enabled as 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 (#173)
  • New option to print all events including all forms of a project
  • Supports repeating events, forms, and sections, even if nested
  • Supports printing all clinical data for a selected subject
  • Optionally add variable names and coded values to PDF export

Improvements

• Compound primary keys (#170)
  • Item data and form status models overwrite existing data on API imports
  • Data imports are now performed in batches to improve performance
• Batched transactions (#172)
  • Persisting hierarchical data uses batched database transactions to improve performance
• Unified CSV and PDF exports (#175)
  • Besides the report module, CSV files can now be downloaded in the export module
  • Besides the forms and subject modules, PDF files can now be downloaded in the export module as well, using the new File System Access API when PDFs for multiple subjects need to be downloaded

v1.9.5 (2024-08-10)

Improvements

• Single choice fields can now be visually represented as select or dropdown menus (#168)
• Forms can be saved with missing mandatory fields when the status is set to incomplete (9d20bec)
• The use of special characters and spaces within subject keys is no longer prevented (ba7dca9)
• Support for count() and sum() in calculation and conditional expressions (a6cce4d)

Bug fixes

• Fix accessibility issues with the range slider field on mobile Safari (iPadOS and iOS) (bcd01f1)

v1.9.4 (2024-08-09)

Improvements

• In addition to events and fields, conditional expressions can now be entered for sections (#166)
• Study events can now be assigned to pre-defined groups (currently general and visits) (#167)

v1.9.3 (2024-08-05)

Improvements

• Adding existing forms to an event can now be done via a tabular view, showing the assignment for all events (#165)

v1.9.2 (2024-08-03)

Improvements

• In addition to forms and sections, events can now be set as repeating (#164)

v1.9.1 (2024-08-02)

Improvements

• Support for date subtraction, floor(), and ceil() in expressions for calculated fields (0efe5b8)
• Copy preferred user name and email when adding non-centrally managed user to another project (dd0a639)

Bug fixes

• Round numeric expression results for calculated fields of type integer (5b4ba75)
• Render translated missing reason in forms and reports (8d56fc4)

v1.9.0 (2024-07-25)

Features

• Calculated fields (#160)
  • Mathematical expressions can be used to automatically calculate fields (usable to calculate the BMI, for example)
  • 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 (#160)

v1.8.0 (2024-07-23)

Features

• End-to-end encryption for clinical data (#156)
  • 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 download from the audit trail (#156)

v1.7.0 (2024-07-11)

Features

• Metadata versioning (#152)
  • Each form / eCRF now either has a version number or is in draft mode, while 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 inconsistencies
• PDF/A export (#154)
  • 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 (#157)
  • 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 available, too – allowing to specifically select which data should be imported
  • Importing CDISC ODM now allows to merge metadata into an existing project while showing already existing events and forms

Improvements

• The eConsent now uses metadata versioning to support arbitrary patient information documents, while showing the signed version for each subject (#153)
• Translated conditions are now rendered directly in the editor fields (#155)
• Customizable preset roles with a defined set of initial rights are now available in the user management module (#157)
• The date picker field now supports the datetime data type (#158)

v1.6.0 (2024-06-13)

Features

• Participant app and self-registration (#149)
  • 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 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 (#151)
• The query details now automatically scrolls to recently made changes to improve collaborative editing (66e5b29)

v1.5.1 (2024-06-04)

Improvements

• Automatically rendered upcoming event periods can now be specifically dated, timed, and persisted per subject (#150)

Bug fixes

• Always render allday before timed events (4901c06)

v1.5.0 (2024-05-28)

Features

• Calendar module for both collaborative and personal date management, supporting timed and multi-day events (#147)
• Scheduled events (or visits) with absolute or relative time periods, including automatic rendering of upcoming events per subject in the calendar and subject modules (#148)

v1.4.1 (2024-04-30)

Improvements

• Catch network connectivity issues when submitting clinical data in subject module and surveys (#146)

v1.4.0 (2024-04-29)

Improvements

• Automatic inactivity logout, which logs out a user after a defined period of inactivity (#144, #27)
• Automatic user account lock after a defined number of successive failed authentication attempts (#145, #28)

v1.3.3 (2024-04-27)

Improvements

• The web app now includes an interactive onboarding tour introducing key features (#143)

Bug fixes

• Unset rather than delete expression data for nested conditional fields (0b49a23)

v1.3.2 (2024-03-25)

Improvements

• Add a cryptographic hash to a form signature to securely identify a specific set of values (#141)
• Allow multi-factor authentication when signing forms (#142)

v1.3.1 (2024-03-20)

Improvements

• Significantly improve performance for loading metadata from the server (#26)

v1.3.0 (2024-03-13)

Features

• Default report to view the audit trail for all audited data models (#139)
• Enable audit trail for metadata and admindata models (#139)

v1.2.0 (2024-03-08)

Features

• Form signatures with re-authentication to take legal responsibility for data (#138)

v1.1.0 (2024-03-02)

Features

• Source Data Verification (SDV) and Missing Reasons (Null Flavors) (#136)
• Preview uploaded files in reports (#133)
• Visually show implicitly given permissions (#131)
• Specify data read and write permissions on a form basis (#130)

v1.0.0 (2024-02-27)

Initial release