OpenEDC Version 2.0

We are introducing OpenEDC Health Version 2.0, a new major version of our platform. It includes features to optimize clinical data collection. These include tabular data views with data matrices, comprehensive metadata versioning, PDF/A-compliant exports for long-term archiving, and end-to-end encryption for protecting personal data.

Data Matrices for Efficient Tabular Data Entry

Collecting structured data in tabular form is a common use case in clinical trials — whether for vital signs, laboratory values, or medication schedules. With version 2.0, we are introducing data matrices that elegantly solve this exact requirement.

Form sections can now be activated as “data matrix”, which automatically displays all input fields in a clear table view. Particularly practical: repeating sections allow for dynamic addition and deletion of table rows, perfect for arbitrarily long lists such as medication intake or follow-up observations.

Consecutive sections with identical or similar questions are intelligently merged into a single table. If needed, a matrix can also be temporarily transposed to edit queries or perform source data verification — maximum flexibility for different workflows.

Metadata Versioning for Professional Data Management

Clinical trials evolve — and the forms used must be able to evolve with them without compromising the integrity of already collected data. With the new metadata versioning, this is now possible.

Each form now has either a version number or is in draft mode. Published forms can no longer be edited directly — instead, a new draft must first be created. This ensures that already collected data always remains associated with the correct form version.

When publishing a draft, the system automatically checks compatibility with already captured clinical data and displays errors for any inconsistencies. This prevents changes to forms from invalidating or falsifying existing data. This feature is particularly important for compliance with Good Clinical Practice (GCP) and regulatory requirements.

PDF/A Exports for Long-term Archiving

Long-term archiving of clinical trial data is a regulatory requirement that demands the highest standards for format and permanence. OpenEDC 2.0 now supports export to PDF/A format — the international standard for electronic long-term archiving.

Individual forms, complete events, or entire study documentations can now be exported in PDF/A format. The export considers all relevant elements: repeating forms and sections, conditional fields, electronic signatures, descriptive texts with images, as well as uploaded files. Empty forms can also be exported, for example as templates or for documentation of the study protocol.

Additionally, an export for the complete study protocol is now available. This includes all events and all forms of a project and can optionally be combined with all clinical data of a selected subject. If desired, variable names and coded values can also be included in the output — ideal for technical documentation or regulatory submissions.

End-to-End Encryption for Personal Data

Data protection is non-negotiable in clinical research. Version 2.0 introduces end-to-end encryption for particularly sensitive data fields that may contain personal information.

Text, date, and signature fields now support optional end-to-end encryption to protect personally identifiable information. The encryption uses the PRF extension for passkeys and thus enables biometric encryption via Touch ID, Face ID, or Windows Hello — maximum security with maximum user convenience.

Technically, a hybrid encryption algorithm is used that combines asymmetric and symmetric methods from the Web Crypto API (RSA-OAEP and AES-GCM). This also enables end-to-end encrypted surveys and participant data via a public project key. Encrypted data can be individually decrypted and viewed by authorized persons in forms, reports, and in the audit trail.

Other News

Other important changes in recent updates briefly summarized:

Calculated Fields with Mathematical Expressions

Fields can now be automatically calculated using mathematical expressions — ideal for calculating BMI, scores, or other derived values. The expression editor has been extended and suggests mathematical operators such as addition, subtraction, multiplication, and division. Calculated fields also support date differences as well as functions like floor(), ceil(), abs(), and round().

Repeating Events

In addition to repeating forms and sections, events can now also be configured as repeating. This enables flexible study designs with multiple follow-up visits or recurring data collection timepoints.

Extended Conditional Logic

In addition to fields, sections and forms can now also be provided with conditional expressions. Events and forms with unfulfilled conditions are still displayed in the subject list but are disabled for editing. A notification explains why a form was disabled or skipped.

Reuse of Codelists

The codelist panel now displays all previously defined codelists and allows their reuse. Codelists are reused as references, not as copies. Additionally, the number of references for each codelist is displayed. This promotes standardization and reduces redundancies.

File Uploads in Documents

The documents module now supports file uploads with support for PDFs, images, and videos. Versioning is supported by uploading new file versions for a specific document. When files are referenced in forms, they are also correctly displayed there.

Improved Study Arms

Event groups can now be defined as arms, with customizable and translated descriptions. Subjects must be explicitly assigned to a study arm to be able to collect data for that arm — important for randomized controlled trials.

Regular Expressions for Text Fields

For fields with text data type, a regular expression can now be specified to restrict data entry. This enables validation of formats such as email addresses, phone numbers, or other structured text values.

Predefined Roles and Extended Permissions

Predefined roles with a defined set of initial permissions are now available in user management. Read and write permissions can now be defined at the form level. New permissions enable locking of forms.

Improved Export and Import

A new export and import module offers detailed options for specific data export or import. When importing CDISC ODM, metadata can be inserted into an existing project, displaying already existing events and forms. Reports and CSV exports now show event and form names in dedicated columns.

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This concludes this post. Thank you for your interest. If you would like to learn more, feel free to schedule a demo.