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Changelog

3.14.0

New

  • Browse 29 step-by-step guides for eCRF and Admin tasks, with screenshots, organized by topic and available in English and French.
  • Open Help from the user menu or Admin navigation to view the guides in a new tab. Changelog opens in the guides with a version list, and release-note formatting is preserved.

3.13.1

New

  • The Admin displays who created or last updated a study or facility site by full name, including in the Studies list.
  • Facility site numbers appear in the Admin under Facility Sites. Subject IDs keep their site number when sites are reordered, removed or added back, so existing subject IDs and links stay the same.

Changed

  • The Admin is available in French across study settings, users and organizations, eCRF and Data Quality blocks, rule and formula editors, operations screens, and validation messages. Rule diagnostics in the Admin and visit form errors in the Subject Matrix appear in the reader’s language.
  • The Admin’s study editor accepts typed Planning Start Date and Planning End Date values, and the validation rule editor keeps long references and messages within its column. Study exports and imports retain SDV sign-off settings and Data Quality configuration.
  • Creating a user now requires choosing a Role. View Available Roles describes each role’s permissions; Clinical Research Associates (Hospital) can answer queries and add comments, Sub-Investigators and Clinical Research Associates (Hospital) can finalize medications and SUSARs, and Clinical Research Administrators can view sign-off read-only but cannot upload files.
  • Clinical Research Administrators can open and manage users in their organization again. Facility Site options are limited to sites in assigned studies.
  • Reopened queries count as unanswered and can receive a new response; closed queries no longer show a response box. Answered-query counts reflect whether a response was added during the current open period.
  • The subject-sharing question at enrollment clarifies that choosing No hides the subject from other non-principal investigators, not from the Principal Investigator or monitors.
  • In French, feedback is called “Retours” to distinguish it from comments. Counts also use the correct singular form when there is one item.
  • New SUSARs start with Expectedness, Reporter type, Dechallenge and Rechallenge unselected, so reporters provide these answers themselves.
  • The Data Quality Rule Status table’s Last Fire retains the time a rule last raised an alert, even after its alerts are acknowledged, suppressed or resolved.

Fixed

  • Publishing study changes is refused when it would also publish another administrator’s unpublished changes to fields the publisher cannot edit.
  • After changing a password, the sign-in page confirms the change; signing in with the new password opens the studies.
  • SDV errors explain when validation errors must be resolved first. A completed visit’s alerts clarify which queries can be answered as-is and where to change the visit status; the sign-off invalidation button now says “Invalidate.”
  • The Suppress alert action requires an expiry date before Confirm is available.
  • A SUSAR or concomitant medication can be closed after its last follow-up or amendment is abandoned. Failed Finalize attempts on adverse event and medication forms show the correct message, and missing subject sex stays blank in a SUSAR rather than defaulting to the first option.
  • The study export dialog displays its ZIP file notice and the French Download Files button is labeled correctly.

3.13.0

New

  • Contact support shows a badge with the number of unread replies. Closing the support chat removes its floating launcher; select Contact support to open the chat again.

3.12.0

New

  • Use Contact support to open the support chat from the sign-in page, password-change page, or app header.

3.11.0

New

  • In the Admin, you can add a Variable Name to eligibility criteria, Conditional Options, satisfaction survey questions, personal history conditions and medical assessment measurements. Names must be safe identifiers and unique within their visit or AE, medication or SUSAR layout.
  • In the Subject Matrix, you can sort subjects by completion or SDV percentage, lowest or highest first, using the Status column menu.

3.10.3

Fixed

  • Date fields in a block duplicated or pasted in the Admin now link to dates in the copy. Publishing a study is blocked if a date field links to a date that is not in the study, with an error shown on the field; affected date links in existing studies are also repaired.

3.10.2

Fixed

  • In French, the Study Progress Over Time chart now displays the study start and end markers and localized month labels, including in tooltips.

3.10.1

Fixed

  • Visits can now be completed when a table has a minimum number of additional rows specified but does not allow users to add rows.

3.10.0

New

  • Run Decoder now includes an offline report with your exported datasets, tables and submission package. Download the output even when the package does not pass its release gates.

Fixed

  • The export dialog now reports when the decoder is unavailable or fails, shows its output when available, and lets you try again instead of reporting success. It also warns when the submission package fails its release gates.

3.9.2

Fixed

  • Sign-in now distinguishes incorrect credentials from a locked account, with a clearer message for each. If a platform error prevents sign-in, you see an error page with a Try again button instead of an incorrect-credentials message.

3.9.1

Changed

  • Tables on phones keep their columns readable and scroll horizontally when they don’t fit the screen. Column widths remain adjustable, with larger resize handles for touch screens.

3.9.0

New

  • Resize columns in the Subject Matrix, Adverse Events, Concomitant Medications, SUSARs, and Data Quality tables by dragging the dividers between column headers. Your widths are remembered in the same browser; double-click a divider to restore the original widths.

Fixed

  • Column widths now stay consistent as you scroll, sort, filter, or collapse a site group. Longer cell content wraps within its column instead of changing the table layout.

3.8.1

No changes you’ll notice in this release.

3.8.0

New

  • The Subject Matrix, Adverse Events, Concomitant Medications, SUSARs, and Data Quality tables scroll within a height-limited area. Scrollbars remain visible when content overflows, and site headers stay pinned as you scroll.

Changed

  • The Subject Matrix appears sooner and opens faster on repeat visits. After a subject is saved, only that subject is reevaluated.
  • The Data Quality tab loads faster, especially in studies with many alerts.
  • Data Quality alerts appear sooner after a save, and evaluations keep up better when many saves happen together.
  • Tables render rows as you scroll. Browser find-in-page only searches rows currently rendered near the visible area.

Fixed

  • The Data Quality tab no longer crashes for studies created with the default layout.

3.7.0

New

  • On phones, one Actions button opens a panel with a field’s or section’s value and available actions. Report actions are available from the Actions column in the same way.

Changed

  • The eCRF and Admin have a refreshed design, with updated forms, navigation, tables and status indicators.
  • Study pages use breadcrumbs and clearer section navigation. Visit steps show completion and status, and visit and sign-off pages provide more study context.
  • Forms and tables are easier to use on phones. Tables scroll within their cards, and form fields take the available width.
  • The Data Quality dashboard presents compact metrics and charts, while its tables scroll within the page instead of extending it.
  • Visit and sign-off pages load faster when calculating completion for subjects at sites with many safety reports.

Fixed

  • Read-only forms and reports no longer look editable, and their saved values remain easy to read.
  • Field validation errors appear with the relevant field, and values in queries and SDV unlocks use the same readable format as the form.
  • French labels are now used for more roles, query and feedback statuses, Data Quality chart values, and sign-in and password-change errors.

3.6.0

Changed

  • Study cards now show loading placeholders for enrollment, query, and alert indicators while counts load.

3.5.0

New

  • Date fields now have a localized calendar for day, month/year, and year values. You can also type dates in the field’s displayed format; calendars use your selected language and time zone.

Changed

  • Study tables and Data Quality tables use a more compact style, with rows grouped by site and expanded by default. You can collapse site groups, and sorting follows the relevant status and scope order.
  • On the Subject Matrix, filters wrap to fit the screen and selected sites stay within the site filter. Data Quality alert actions appear as single-line icon buttons with tooltips.
  • In the Admin, mouse, keyboard, and navigation activity keep your session active. You’re asked to confirm that you want to stay signed in during the last minute of the session.

Fixed

  • The facility site filter remains available on the Concomitant Medications and SUSARs tabs after you select a site, so you can change or clear your selection. Filtering adverse events by site now shows the selected site’s events.
  • Month/year-only and year-only fields now save the selected date at the correct precision. Invalid or incomplete dates aren’t saved.

3.4.0

New

  • Study cards show enrollment progress, open and answered queries, and critical Data Quality alerts. Users restricted to a site see query and alert counts for their site.
  • The study Overview tab includes an Open Queries card with counts by site and visit. Select a row or count to open the Subject Matrix filtered to that site’s subjects with open queries; the matrix also has filters for open queries and answered queries.
  • The Total Participation Status card shows the male and female participant counts and their share of enrollment, with an Unknown category when applicable.

Changed

  • Visit Schedule tooltips show query totals rather than listing counts by site; the Open Queries card now provides that breakdown. Study dashboard labels are translated into French, and English chart labels use “subjects” consistently.
  • The sign-off page explains that only the principal investigator can sign off a subject’s eCRF and asks users who cannot sign to notify them when it is ready.

Fixed

  • Users restricted to a site no longer see study-level rules or alerts from other sites in Data Quality, or access their history and actions. Alerts for participants they cannot access are also unavailable.
  • Study-level Data Quality rules use data from every site when a save triggers an evaluation, so their alerts no longer incorrectly open or resolve based only on the saving site’s data.

3.3.0

New

  • Administrators can now create, download, and restore backup archives larger than 5 GB in the Admin.

Changed

  • If an update fails, the eCRF and Admin automatically return to the previous version after restoring the pre-update backup, reducing service interruption.
  • The Admin now verifies backup storage settings when you save them, so incompatible settings are flagged before you run a backup.

3.2.1

Changed

  • Study export archives are kept for 24 hours. If a download link has expired, run the export again.

Fixed

  • Saving a new adverse event, concomitant medication or SUSAR no longer creates duplicates when you double-click Save Draft or save at the same time as another user. Concurrent reports receive distinct IDs, and a SUSAR already linked to an adverse event is shown in the SUSAR list without a page reload.
  • Double-clicking Finalize, Submit or Close no longer shows a false failure for adverse events. Safety report forms prevent duplicate actions while a save or status change is in progress, and abandoning a SUSAR follow-up or medication amendment only runs once.
  • Status changes now explain when required fields are incomplete, visit completion explains when answers are missing or invalid, and closing a medication without an end date gives a clear message. You can start a SUSAR follow-up or medication amendment from an incomplete report and correct the issues in the new draft.
  • When a study reaches its subject limit while the Add New Subject dialog is open, Confirm explains that no more subjects can be added and the subject matrix refreshes.
  • Opening a study you cannot access now shows “Page not found” instead of an error page. Opening another user’s private subject redirects to the study overview, and malformed subject links return to the study list.
  • Field SDV is disabled when an open query on the field or a containing section prevents verification. The tooltip explains which queries must be closed, and the SDV error gives the same reason if the page is out of date.

3.2.0

New

  • Open Changelog from the user menu to read release notes in English or French.

Changed

  • Choose a Time zone in the user menu. Event times appear in your selected zone with its name; until you choose one, they appear in UTC.
  • Study exports include the creator’s role and user ID alongside their name and email, and include the last modifier’s details where available. Older records may not have role and user ID information.

Fixed

  • When your account is locked, re-entering your password to lock or unlock a study or sign off a subject tells you to try again later instead of reporting an incorrect password.

3.1.0

New

  • Data Managers, Clinical Research Administrators and System Administrators can lock a study with Lock Study, giving a reason and their password. A locked study’s data is read-only for everyone: no enrollment, data entry, SDV, queries, sign-offs, safety reports or Data Quality alert changes, while viewing and exports stay available.
  • Every page of a locked study shows who locked it, when and why. Unlock Study, also with a reason and a password, makes its data editable again.
  • A locked study is shown and exported with the study version that was published when it was locked.
  • If a study is locked while you have a form open, saving tells you who locked it and when, and your changes stay on the page so you can save them once it’s unlocked.
  • You can export the subjects the Subject Matrix’s filters show, or a single subject from its eCRF with Export Subject Data. Both offer the same options as Export Data, including Include Change History.
  • Principal Investigators can export data, limited to their own site’s subjects.

Changed

  • A form your role can’t edit, such as a monitor’s visit form, now says it’s read-only for your role instead of locked. Disabled buttons say whether your role can’t do something or the form is locked.
  • Demographics in an export describe the exported subjects, using each subject’s current age, and site averages are no longer rounded down to whole years.

Fixed

  • Exports no longer fail when a study has concomitant medications or SUSARs.
  • Gender counts in a study’s demographics no longer merge subjects from different sites, such as site 1’s subject 23 and site 12’s subject 3.

3.0.0

No changes you’ll notice in this release.

2.0.0

Changed

  • Everyone signs in again once after this update.
  • The admin has its own address, usually your eCRF address with “admin.” in front, and you sign in to it separately.
  • Opening the address of a subject who isn’t enrolled yet takes you to the study’s overview instead of enrolling them. Only Add Subject enrolls a subject.

Fixed

  • Opening a study without a tab, or its Data Quality tab when Data Quality is off, takes you to its Overview instead of a page that doesn’t exist.
  • After you change a subject’s age or gender, the subject no longer shows you as its creator until the page reloads.

1.2.0

No changes you’ll notice in this release.

1.1.1

No changes you’ll notice in this release.

1.1.0

Fixed

  • Studies that failed to open in the admin with a field configuration error open again.

1.0.0

The first numbered release of Veritas eCRF.