Captivate Release Notes
Captivate Release Notes
Welcome to the Captivate Software Release Notes Page!
As part of our 4.0 release, we created a new page where you can see detailed information about each release’s changes. We release major updates quarterly and minor updates on an ad hoc basis.
All major releases are designated as x.xx.0, and minor releases are designated as x.xx.x. All minor releases are included in the next major release. For example, versions 3.17.1 and 3.17.2 have enhancements and bug fixes part of 3.18.0.
We recommend being on the most current version to enjoy all new features, performance, and security enhancements!
If you have any questions, please get in touch with us at [email protected].
Please note, we are working backward from 4.0, so our early releases do not have notes yet!
Captivate 4.4
Captivate 4.4 Overview – released December 21st
We are excited to announce many powerful new enhancements in this release!
- New Feature: Support for Single Sign-On (SSO)
- New Rule Action to Automatically Assign Subjects to Groups
- Data Review Enhancements (Export Option & New CRF Attributes)
- Enhanced Discrepancy Note Page to Preserve Validation Failure Reasons
- Dataset PHI Enhancements (New PHI Status Options & Updated Download Logic)
- Enhanced User and Role Locking (New “Lock All Roles” Functionality)
- New Help Menu Pages: Release Notes & eLearning
- Support for MedDRA 28.1 Coding Dictionary
- Support for WHODrug September 2025 Coding Dictionary
- Enhanced Forms Library Pages (Improved Performance & Pagination)
- Improved Form Builder Logic (Removed Read-Only + Required Combination)
- Updated jackson:fasterxml Libraries for Security & Compliance
For more specifics, please see the detailed release notes below.
Email [email protected] if you would like to schedule a demo of our 4.4 features!
4.4 Enhancements
| Summary | Impact | Release | Internal ID |
|---|---|---|---|
| New feature added to support Single Sign-On (SSO) |
This release introduces support for Single Sign-On (SSO) using Microsoft Entra ID, allowing organizations to centrally manage user authentication. Administrators can configure their Entra organization so users can log in using an external identity provider instead of a platform password. The user creation process has been updated with a new “Use External Identity” option, and the login page now includes separate tabs for standard login and organization login. |
4.4 | C-2685 – C-2699 |
| Add new Rule Action to allow assignment of a Subject to Group |
A new Rule Action allows users to automatically assign subjects to specific groups based on rule criteria. Previously, assignments were manual or randomized; now the system can update group status based on data—for example, automatically setting Enrollment Status to “Screen Failed” if screening criteria are not met. The Captivate Report – Subject Status can be used to view counts per group. |
4.4 | C-2612, C-2613, C-2614, C-2615, C-2616, C-2617 |
| Data Review Enhancements |
An Export option has been added to the Data Review page, allowing users to easily download reviewed data. This enhancement streamlines reporting and supports quicker data sharing outside the platform. |
4.4 | C-2540 |
| Enhanced Discrepancy Note page to include more details |
The Discrepancy Note page has been enhanced to ensure the Detailed Description always retains the default Failure Validation Reason. Previously, users could remove this message, causing the original validation context to be lost. If removed, the system now automatically reinserts it at the beginning of the field. |
4.4 | C-2704 |
| Dataset PHI Enhancements |
The PHI status in datasets now supports three options: “No PHI,” “PHI Masked,” and “PHI Not Masked.” This update provides clearer visibility into which roles can download datasets containing PHI. |
4.4 | C-2627 |
| Dataset PHI Enhancements |
Dataset download logic has been updated to align with the new PHI statuses and the “Apply PHI Protection to Exports by Study” setting. Study-level roles and users without an active site context may download only PHI Masked or No PHI items, while site-level users may download all PHI statuses. |
4.4 | C-2628 |
| Enhanced User and Role Locking |
Locking at the user level previously locked the user across all studies. This has been replaced with “Lock All Roles,” which locks all of a user’s roles only within the selected study. Users’ access in other studies remains unaffected. |
4.4 | C-874 |
| Add more resources under Help Menu |
Two new pages—Release Notes and eLearning—have been added under the Help menu. These pages provide convenient access to training resources and information about new features and bug fixes. |
4.4 | C-2674 |
| Data Review Enhancements |
New CRF attributes have been added to datasets, including Data Completion Status, SDV Status, Data Review Status, and Sign Status. The overall CRF Status remains and reflects the highest-level state across Completion, SDV, and Signed statuses. As part of CAP-2585, “Select All Attributes” now includes these new attributes. |
4.4 | C-2541, C-2585 |
| Add support for MedDRA 28.1 coding dictionary | Added support for the MedDRA 28.1 coding dictionary. | 4.3.2 | C-2618 |
| Add support for WHODrug Sept 2025 coding dictionary | Added support for the WHODrug September 2025 coding dictionary. | 4.3.2 | C-2619 |
| Enhanced My Forms page |
The My Forms Library has been updated with the new Forms page, improving performance and navigation. Users with large numbers of forms will benefit from the new pagination support. |
4.4 | C-2592 |
| Enhanced Advanced JavaScript Forms page |
The Advanced JavaScript Forms page has been updated with the new Forms layout, improving usability and performance. Pagination has been added for users managing large numbers of forms. |
4.4 | C-2593 |
| Enhanced Clone Library Form page |
The Clone Library Forms page has been updated with the new Forms layout. This enhancement provides better performance and a more consistent experience across form management tools. |
4.4 | C-2603 |
| Removed the ability to have a read-only item, also required |
The form builder no longer allows items to be marked as both read-only and required. This prevents hard edit traps where users were required to enter data but unable to do so, resulting in unnecessary discrepancy notes. |
4.4 | C-2577 |
| Update jackson:fasterxml libraries |
The jackson:fasterxml libraries have been updated to the latest supported versions. This ensures improved security, compliance with modern library standards, and alignment with current dependency best practices. |
4.4 | C-2643 |
4.4 Bug Fixes
| Summary | Impact | Release | Internal ID |
|---|---|---|---|
| Fixed password loop issue |
Fixed an issue that occasionally caused users to become stuck in a password reset loop. After setting a new password, users were sometimes prompted to create another one immediately upon login. The root cause was the last_activity date not being updated in all password reset processes,which triggered repeated resets. This has been corrected. |
4.4 | C-2623 |
| Fixed issue for changing passwords when the study is not selected |
Fixed an issue where users were unable to change their password if no study was selected. Password changes can now be completed successfully before selecting a study. |
4.4 | C-2660 |
| Fixed issue on Form Action |
Fixed an issue where the Actions button was partially cut off on the new Forms list when only a single form was displayed. The button now renders correctly in all cases. |
4.4 | C-2579 |
| Fixed issue on Edit Event Page for Discrepancy Note flag icon |
Fixed an issue where updating a query linked to an event’s Start/Stop date on the Edit Event page caused the query icon to display incorrectly. Instead of showing the proper yellow or green status icon, it displayed a corrupted icon and the text “Discrepancy Note.” The correct icon behavior has now been restored. |
4.4 | C-2260 |
| Fix issue for Data Manager at site and view queries |
Fixed an issue where Data Managers with a site selected were redirected to the main landing page after viewing a query, editing data, saving, and navigating back. The system now correctly returns them to the Queries page as expected. |
4.4 | C-2567 |
| Fixed issue in VDC navigation buttons when Exit is selected |
Fixed a rare issue where the “Submit Final Form” option would appear prematurely in the VDC button menu after selecting “Exit and Clear Forms” and then choosing “No” in the confirmation pop-up. The button now displays only when appropriate. |
4.4 | C-2584 |
| Fixed issue with importing data in forms with tables |
Fixed an issue that occurred when importing a CSV file containing multiple tables with blank data while choosing to override with blank values. Previously, this scenario triggered an error and prevented the import from completing. The import now succeeds as expected. |
4.3.1 | C-2599 |
| Fixed TMF File Path and Page Number dropdown overlapping |
Fixed an issue where the eTMF File Path and Page Number fields overlapped in the interface. These elements now display correctly without visual obstruction. |
4.3.1 | C-2609 |
| Fixed regression from 4.2 causing Reason for Change to be generated during data import for not Completed CRFs |
Fixed a regression introduced with the Auto-Generate RFCs feature in version 4.2. Reason for Change entries were incorrectly being added when data was imported into CRFs that were not marked complete. The system now correctly avoids generating RFCs in these cases. |
4.4 | C-2563 |
| Fixed issue where incorrect default options are displayed for Lists and Checkboxes when entering data |
Fixed a rare issue affecting list and checkbox fields configured with option names “1”, “2”, “3” and values “0”, “1”, “2” when a default option was selected. During data entry, the incorrect option would appear selected, and during data review no option appeared selected. The system now correctly preserves and displays the chosen value. |
4.3.3 | C-2611 |
Captivate 4.3
Captivate 4.3 Overview – released September 15th
We are excited to announce many exciting new enhancements!
- New Data Manager Role
- VDC Improvements
- Future Date Item Configuration
- eTMF Improvements
- Discrepancy Notes for Event Status
- Added SAS Name to Metadata Report
- Export & Dataset Job Link Security Enhancements
- Add Row Number Option on Forms, Sites, and Users Pages
For more specifics, please see the detailed release notes below.
Email [email protected] if you would like to schedule a demo of our 4.3 features!
4.3 Enhancements
| Summary | Impact | Release | Internal ID |
|---|---|---|---|
| New Data Manager Role |
To complement the new Data Review status, we have a new user role – Data Manager. This role has the following access and abilities:
|
4.3 | C-2514, C-2523 |
| VDC Improvements | Enhanced the VDC interface with the following minor updates to improve usability and overall look and feel:
|
4.3 | C-2554, C-2576 |
| Future Date Item Configuration |
Users now have the ability to set a date to allow or not allow future dates directly within the form build.
This greatly reduces rule creation, and since it is associated with a form item, it can be cloned to many other forms or studies. |
4.2.1 | C-2515, C-2516 |
| eTMF Improvements | As part of our ongoing enhancements to our new eTMF feature we have added the following:
|
4.3 | C-2466, C-2467 |
| Added Discrepancy Note to Event Status | Users can now add a discrepancy note to the event status to document the reason for change. | 4.3 | C-2548 |
| Added SAS Name to Metadata Report | SAS Name is now included in Metadata CSV export under Forms –> Download Metadata Report and Form Metadata under Form –> View Details in the items section. | 4.3 | C-2524 |
| Export and Dataset Job Link Security Enhancements | Previously, users could forward dataset email and the dataset would download for people with access to the cloud, but potentially not the study. Now the dataset job email checks study and permission access of the dataset prior to initializing the download. | 4.3 | C-2535 |
| Add Row Number to New Pages | Users can select the number of rows displayed on updated Forms, Sites, and Users pages. | 4.3 | C-2555 |
| Read Only To More Item Types |
In the form build, now Lists, Radios, Checklists, Date, and Time items can be set to read only. Prior, only text and number items had this capability.
Please note the functionality on the live side (data entry) will be released in 4.3.1. |
4.3 | C-2558 |
4.3 Bug Fixes
| Summary | Impact | Release | Internal ID |
|---|---|---|---|
| Item Instruction Tooltips | Fixed an issue where cloned CRF item instruction tooltips were too narrow to display text properly. | 4.3 | C-2550 |
| Missing Button Tooltips | Restored missing button tooltips on hover in the Study Documents and Users pages. | 4.3 | C-2386 |
| iFrame Back Button Issue | Fixed a bug where using the browser Back button after starting to create a study showed a blank page instead of returning to the Study page. | 4.3 | C-2450 |
| Subject Matrix Filter | Fixed a bug where multiple filters (e.g., Event and Subject ID) were not applied together as expected. | 4.3 | C-2471 |
| Study Admin User Role Lock | Resolved inconsistencies when locking a Study Administrator role; the Users page previously continued to show the role as available, and it could not be unlocked. | 4.3 | C-2511 |
| Item Configuration Fields Missing in Grids | Fixed an issue where some item configuration options disappeared when items were dragged into a grid. | 4.3 | C-2525 |
| eTMF Access Controls | Users without eTMF access can no longer open study documents via direct link; they are redirected to ‘No Access’. Please note, users would need study access to access link. | 4.3 | C-2553 |
| Dataset PHI Flag | Fixed dataset PHI status; previously always set to ‘No’, now correctly reflects if a dataset contains PHI. | 4.3 | C-2195 |
| Missing Headers on Sign and SDV | Regression from 4.2; headers now correctly populate when popping up a CRF under the View button. | 4.3 | C-2513 |
| Clone Option Greyed Out for Company Standards | Regression from 4.2; clone option now available again for Company Standards. | 4.2.3 | C-2572 |
Captivate 4.2
Captivate 4.2 Overview – Released July 13th, 2025:
We are excited to announce FOUR exciting new features!
- Data Review Workflow
- User and Role Audit Logs
- Metadata CSV Export (Full Data Dictionary)
- Divider Enhancements
For more specifics, please see the detailed release notes below.
Email [email protected] if you would like to schedule a demo of our 4.2 features!
4.2 Enhancements
| Summary | Impact | Release | Internal ID |
|---|---|---|---|
| Data Review Workflow |
Introduced a powerful new Data Review Workflow that enables CRFs to include an additional Data Review status. This status can be configured as required or optional and may function independently of or alongside the SDV workflow. This advancement strengthens monitoring capabilities, improves data oversight, and enhances overall study quality control. |
4.2 | C-2473 – C-2485 |
| User and Role Audit Logs |
Introduced enhanced User and Role Audit capabilities that provide Study Administrators with greater visibility into user-related activity. Administrators can now view when users are invited, activated, and when role permissions are modified. This delivers improved transparency, accountability, and compliance oversight across study teams. |
4.2 | C-2345 – C-2464 |
| Metadata CSV Export (Full Data Dictionary) |
Expanded metadata export functionality to allow generation of a complete study-wide data dictionary. Previously limited to exporting one form at a time, users can now export all metadata in a single comprehensive file. This enhancement simplifies documentation workflows and delivers clearer, more actionable study insights. |
4.2 | C-2372 |
| Divider Enhancements |
Enhanced divider functionality within Forms to support skip logic visibility, placement before tables, usage as the final item on a page, and placement before page breaks. These updates provide greater flexibility in form configuration and improve the overall user experience. |
4.2 | C-2402 – C-2521 |
| Form and Site Pagination |
Introduced pagination to the Forms and Sites pages, improving performance and scalability. This enhancement enables faster navigation and a more efficient experience when managing large studies. |
4.2 | C-2392 – C-2459 |
| Added MEDDRA 28.0 in the current version of medical coding |
Updated the medical coding dictionary to include MEDDRA 28.0. This ensures studies remain aligned with the latest regulatory coding standards and industry best practices. |
4.1.5 | C-2502 |
| Add support for WHODrug March 2025 coding dictionary |
Added support for the WHODrug March 2025 coding dictionary. This update ensures access to the latest drug classification data and supports accurate and compliant coding workflows. |
4.1.5 | C-2503 |
| Improved Handling of job misfire/shut down problems |
Strengthened system stability by improving handling of job misfires and shutdown scenarios. These improvements enhance reliability, reduce operational interruptions, and provide a more resilient platform experience. |
4.2 | C-2319 |
| Add Email Address to Audit Log for VDC |
Enhanced audit log visibility by including email addresses in VDC audit entries. This provides clearer traceability of user actions and strengthens overall audit transparency. |
4.1.2 | C-2358 |
| Show Rule Discrepancy Text |
Improved rule discrepancy visibility by displaying detailed discrepancy text directly within the interface. This enhancement allows users to more quickly understand and resolve rule-related issues. |
4.1.2 | C-2374 |
| Add a PHI flag to the dataset files |
Introduced a PHI flag within dataset files to clearly identify protected health information. This enhancement strengthens compliance awareness and supports improved data governance practices. |
4.1.1 | C-2432 |
| Added study/site OID in Full Subject Audit Log Export |
Enhanced the Full Subject Audit Log Export to include Study and Site OIDs. This provides greater traceability within exported audit data and improves downstream data analysis capabilities. |
4.1.1 | C-2426 |
| Auto-generate RFCs when importing data |
Introduced automatic RFC generation during data import. This streamlines discrepancy management workflows and improves operational efficiency when updating study data. |
4.2 | C-2443 |
| Add an extra line in the Audit Log when importing and overwriting data |
Enhanced audit logging during data import by adding an additional entry when data is overwritten. This provides clearer visibility into data changes and strengthens audit trail completeness. |
4.2 | C-2444 |
4.2 Bug Fixes
| Summary | Impact | Release | Internal ID |
|---|---|---|---|
| Subject Audit Log Export row number and occurrence handling | Fixed an issue where Subject Audit Log Export could generate incorrect row numbering and occurrence handling. The export now consistently reflects accurate subject data. | 4.1.1 | C-2420 |
| Insert rules creating multiple occurrences in non-repeating events | Fixed an issue where Insert Rules could create extra occurrences in non-repeating events due to incorrect study subject resolution. The rule execution logic has been corrected to ensure proper entity mapping and event handling. | 4.1.1 | C-2429 |
| Subject Audit Log Export PHI masking | Fixed an issue where PHI values were not properly masked in the Subject Audit Log Export. Sensitive data is now correctly protected. | 4.1.1 | C-2434 |
| Form publishing state inconsistency | Fixed an issue that could prevent forms from publishing correctly due to database-level function name conflicts. The publishing workflow now ensures backend validation completes successfully before marking a form as Published. | 4.1.2 | C-2446 |
| Subject Audit Export occurrence number display | Fixed an issue where Subject Audit Export occurrence numbers were not displayed correctly. Exported data now reflects accurate occurrence values. | 4.1.2 | C-2447 |
| Subject Audit Log Export exception handling | Fixed an issue where Subject Audit Log Export could fail or generate incomplete files due to a regression. The export process now completes reliably and displays correct localized status labels. | 4.1.2 | C-2448 |
| SDV status not reflected in audit log export | Fixed an issue where SDV status updates were not properly reflected in the Subject Audit Log Export. The export now accurately displays SDV status changes. | 4.1.3 | C-2393 |
| Sign workflow subject mismatch | Resolved a critical issue in the sign workflow where, under rare conditions, signing a subject could incorrectly affect another subject record. The signing process now correctly validates subject associations. | 4.1.3 | C-2433 |
| Form sign status dropdown update issue | Fixed an issue where form sign status values were not updating correctly after event changes. Status values now reflect the correct current state. | 4.1.4 | C-2390 |
| Sign workflow inconsistencies | Resolved inconsistencies in the sign workflow to ensure event signing and unsigning actions behave as expected across all scenarios. | 4.1.4 | C-2428 |
| Incorrect audit log entries for item data changes | Fixed an issue where incorrect or duplicate audit log entries could appear for item data changes. Audit logging now accurately reflects user actions. | 4.1.4 | C-2430 |
| Event unsigning regression | Fixed a regression affecting event unsigning behavior. Events can now be unsigned correctly without unintended side effects. | 4.1.4 | C-2472 |
| Rule expression binding issue | Resolved an issue with rule expression binding where certain conditions were not evaluated correctly. Rule logic now applies as intended across events. | 4.1.5 | C-2505 |
| Iframe double-click navigation issue | Fixed an issue where double-clicking buttons could cause navigation outside of the iframe. Button handling now prevents unintended page transitions. | 4.2 | C-1911 |
| Tooltip display alignment issue | Fixed a regression affecting tooltip positioning. Tooltips now display in the correct location. | 4.2 | C-2382 |
| Subject Audit Log Export access for site administrators | Fixed an issue where site-level Study Administrators could not access the Subject Audit Log Export. Access permissions now function correctly. | 4.2 | C-2388 |
| PHI status handling in dataset extraction | Fixed an issue affecting PHI status handling in dataset extraction files. PHI indicators now correctly reflect configured data privacy settings. | 4.2 | C-2451 |
| Download Metadata double-click issue | Fixed an issue where double-clicking the Download Metadata button could trigger unintended behavior. The button now executes only a single action per click. | 4.2 | C-2508 |
| User display refresh issue | Resolved an issue where newly added users did not immediately appear in the User interface. User records now display correctly after creation. | 4.1.4 | C-2490 |
| Query view error for site-level roles | Fixed an error that occurred when site-level users attempted to view queries within a record. Queries now load correctly for applicable roles. | 4.2 | C-1997 |
| Email Log sorting regression | Fixed a regression that caused the Email Log page to fail to render after sorting. Sorting now functions correctly. | 4.2 | C-2328 |
| Create Study tab closure error | Fixed an issue where closing the Create Study page tab could cause application errors. The interface now handles tab closure safely. | 4.2 | C-2415 |
| Form mass cloning version reset | Resolved an issue where version values were not correctly reset during form mass cloning. Cloned forms now maintain proper versioning. | 4.2 | C-2421 |
| Form status remains In-use after Save and Exit | Fixed an issue where forms could remain marked as In-use after Save and Exit. Form status now updates correctly. | 4.2 | C-2422 |
| Portal blank screen when searching user ID | Fixed an issue where the Portal could display a blank screen when searching for certain user IDs. The search function now loads properly. | 4.2 | C-2439 |
| User role unlock on disabled site | Fixed an issue preventing user roles from being unlocked on disabled sites. Role management now functions correctly for all site states. | 4.2 | C-2512 |
| Incorrect form count during filtering | Fixed an issue where the number of forms displayed during filtering was incorrect. Filtering results now reflect accurate counts. | 4.2 | C-2520 |
Captivate 4.1
Captivate 4.1 Overview – Released March 16th, 2025:
We are excited to announce two exciting new features!
- eTMF Feature to store study and site documents
- Full Subject Audit Log to export the audit log for all subjects at once
For more specifics, please see the detailed release notes below.
Email [email protected] if you would like to schedule a demo of our 4.1 features!
4. 1 Enhancements
| Summary | Impact | Release |
|---|---|---|
| eTMF Feature | You can now Create Study Folders, Store Study Documents, Store Site Documents, Version Control, Manage Study/Site Document Permissions all in one spot within Captivate! | 4.1 |
| All Subjects Audit Log Export | You can now generate comprehensive audit logs for every subject associated with a study site. | 4.1 |
| Enhanced item instructions. | Item instructions now includes the width to allows customers to control the size of instructions. | 4.1 |
| Enhanced PHI controls | Enhanced PHI controls so that once an item is marked as PHI it can’t be changed. | 4.1 |
| Enhanced Security | Removed the ability to launch a CSV injection | 4.1 |
| Enhanced Security | Enhanced security on the Build Study page links. | 4.1 |
| Enhanced Form Builder | Enhanced form builder to show create date for each form version. | 4.1 |
| Enhanced Study Audit Log | Added MFA configuration changes to the study audit log. | 4.1 |
4.1 Bug Fixes
| Summary | Impact | Release |
|---|---|---|
| Fixed Promotion of Disabled CRFs | Fixed an issue when promoting forms’ disabled status; the post-promotion job did not update the disabled status on production. | 4.0.1 |
| Resend Email Button | Updated the Resend Email button to lock after the first click. | 4.1 |
| Fixed Mobile Preview | Fixed issue in VDC Mobile Preview that caused layout corruption when buttons were clicked many times. | 4.1 |
| Promotion Pop-up | Fixed the issue with the promotion message pop being generated multiple times. | 4.1 |
| Fixed issue when for sending completed CRF Emails | Fixed an issue when a Subject ID had a comma, the completed CRF email (if enabled) would not send. | 4.1 |
| Fixes issue viewing discrepancy notes | Fixed issue when viewing a discrepancy note then going to event page and pressing back. | 4.1 |
| Added status change for Not Scheduled events to Locked to Audit Log. | Added status change for Not Scheduled events to Locked to Audit Log. | 4.0.1 |
| Fixed Site Audit Page to include values | Fixed issue to show the values of ‘CRF status after import’ and ‘Collect Subject Date of Birth’ parameters. Previously, the IDs were shown. | 4.1 |
| Fixed issue in datasets for non-repeating events | Fixed an issue that occurred when extracting data for non-repeating events that were previously marked as repeating. | 4.0.1 |
| Fixed issue in Discrepancy notes export | Fixed issue when a Site ID had a comma, the Discrepancy Notes export did not download. | 4.0.1 |
| Fixed issue in display of previously locked medical coded term | If a locked subject had previously coded items, the Code button was not green, and the Delete Code button was absent. The terms were also not included in summary statistics. This change affects only the UI and locked subjects. Before the change, medical coding terms remained on the CRF and the dataset, and locked subjects codes could not be edited. | 4.0.1 |
Captivate 4.0
Captivate 4.0 Overview – Released November 22nd, 2024:
- Added a reverse visual analog scale and updated the medical coding dictionaries to include the MEDRA V27.0 and WHODrug March 2024
- PHI security enhancements, print Form fixes, fixed pop-up messages, updated Subject Casebook
For more specifics, please see the detailed release notes below.
While this release was primarily maintenance fixes, behind the scenes, we have been preparing our eTMF feature and integrations for large file storage for site documents and reporting. Email [email protected] if you would like to be on the list for early demo and release of eTMF!
4.0 Enhancements
| Summary | Impact | Release |
|---|---|---|
| Added Reverse Visual Analog Scale. | You can now have a scale item type go from Max to Min. This is helpful for validated instruments like the EQ-5D. | 4.0.0 |
| Added WHODrug March 2024 coding dictionary | If medical coding is enabled in your study, you can select these new dictionaries on the medical coding item.
If you want to add medical coding, contact us at [email protected] |
3.18.1 |
| Added MEDDRA v.27.0 coding dictionary | If medical coding is enabled in your study, you can select these new dictionaries on the medical coding item.
If you want to add medical coding, contact us at [email protected] |
3.18.1 |
| Removed the ability to download an uploaded file from the audit trail. | The deleted files are now disabled in the audit trail. This feature was added to ensure that if a potentially unmasked PDF was uploaded and then deleted, it could not be viewed by any user, even after removal. The upload and delete actions are still captured in the audit trail. | 3.18.1 |
| Updated pop-up messages on rule saving. | After editing and saving a rule, when it is valid, the pop-up message now says, “Congratulations, rule editing passed.” | 4.0.0 |
| A study status check was added to running jobs and sending notifications. | If the study status is archived, the job will not run, and notification will not be sent. | 3.18.3 |
4.0 Bug Fixes
| Summary | Impact | Release |
|---|---|---|
| Additional characters were removed from the print form for the Label Table. | Previously labeled tables had [CDATA] text next to the label, which was removed.
Upgrade to enjoy better printing forms! |
3.18.1 |
| Updated the method to get the Subject Creation Date and User Name when the Subject ID did not match the Study Subject ID in Casebooks. | We used an incorrect query to fetch the Subject Create Date and user name in Casebooks. When a Subject is not added to a site, the Study Subject ID has yet to be generated and can become out of sync with it. The method to get the Subject Creation Date and User Name used the Study Subject ID, and if it were different from the Subject ID, it would return an incorrect audit log row.
This is a rare situation when subjects are not added at a site, and Subject ID and Study Subject ID become out of sync. It only affected Casebooks and the Subject Creation Date/User Name. Customers can regenerate subjects’ casebooks after upgrading. |
3.18.1 |
| Logic was added to the print site CRF based on site-level settings. | If a CRF was hidden on the event level and a Study Admin went to Build–> Site–> Print All Site CRFs, it would not print hidden CRFs because the logic was missing to check site-level CRF settings and print based on study-level settings.
Enjoy printing all your CRFs! Tip: If you want a PDF of all your CRFs but have site-hidden CRFs, create a test site on your test study and show all CRFs for that site. Then, you can print all your CRFs with the-click-of-a- button. |
3.18.3 |
| The Print All Site CRFs button was updated not to cut off the last CRF. | A function was added to include HTML tags to denote the end of the form and end of file. | 3.18.3 |
| Fixed regression in password reset in the Change Password menu. | After logging in, users could not reset their passwords under the Change Password menu. This is a regression from 3.18.1. We recommend upgrading to a higher version than 3.18.1. | 3.18.2 |
| Updated message for selected a locked form version. | Previously, when selecting a locked form from the Edit event page, the message would say, “CRF Version is not available”. Now, it includes the name and version of the CRF to help the user resolve the issue. | 4.0.0 |
| Update pop-up messages to only show once. | Previously, some pop-up messages would show multiple times. This is now fixed. | 4.0.0 |
| Added validation on edit user. | When editing a user prior to them accepting the invitation, and special characters were included, it would prevent the user from being able to finish creating their account. | 4.0.0 |
| Removed html tags on pop-up message on promote page | Previously, there were HTML tags included in the Promote CRF pop-up message. These have been removed. | 4.0.0 |
| Fixed pop-up messages on Import data. | Previously, when importing data and there was an issue with the file, the pop-up messages were unclear, and you could not go to the next page. This is now fixed with a pop-up explaining that the import has failed validation. | 4.0.0 |
| Fixed error when viewing a query for Site Level Roles | If a site-level user went to the queries page, viewed a query, then edited data, pressed saved and back, they were directed to the main landing page instead of queries. | 4.0.0 |
| Updated SDV button to only be triggered once | Previously, a user could click the SDV button multiple times, triggering multiple actions. Now, once clicked, the button is disabled and cannot be clicked again until the status update is done. | 4.0.0 |
Captivate 3.18
Captivate 3.18 Overview – Released July 28th, 2024:
This release contains minor under-the-hood improvements and bug fixes to improve the efficiency and performance of your study.
For more specifics, please see the detailed release notes below.
3.18 Enhancements
| Summary | Impact | Release |
|---|---|---|
| Speed Improvements for Dataset Creation | Updated Select All Items method in Datasets to speed up the Create and Edit Datasets pages. | 3.17.1 |
| Speed Improvements for Dataset Creation | Updated Select All Items method to speed up on Edit Datasets | 3.17.1 |
| Speed Improvements for Dataset Creation | Updated the method of adding items to datasets. | 3.17.1 |
| Updated the Audit Log to mask PHI after form was unpublished | Previously, the PHI flag was stored within form details, and when unpublished, the flag no longer existed, which caused the audit log to show PHI for unpublished form data. | 3.17.1 |
| Enhanced speed for selecting and viewing occurrence | Enhanced speed for selecting and viewing occurrences of repeating events | 3.17.1 |
| SMS Study Account was added. | User can set up their SMS Accounts under Study Configurations. | 3.18 |
| SMS Study Account Configuration | Implemented new UI property Study Name, and creation of Twilio subaccount | 3.18 |
| SMS Study Account Configuration | Automatically close a Twilio subaccount when a study is archived or decommissioned. | 3.18 |
| SMS Study Account Configuration | SMS Sub Account Credentials were added so customers can selected their own phone number. | 3.18 |
| SMS Study Account Configuration | Implemented a new SMS Usage page on Study Configurations. | 3.18 |
3.18 Bug Fixes
| Summary | Impact | Release |
|---|---|---|
| Under Forms Audit, the column Parameter displayed “— ?ordinal?”. It is now fixed to display “Ordinal”. | Under Forms Audit, the column Parameter displayed “— ?ordinal?”. It is now fixed to display “Ordinal”. | 3.18 |
| Fixed CRF version text to display Version Number instead of ‘zzz’. | When reassigning a new CRF version, on the confirm page, the select CRF Version would display ‘zzz.’ It now correctly displays the selected version number. | 3.18 |
| When a user clicked the sign button under Monitor Signatures multiple times, the pop-up box went blank. | None | 3.18 |
| The Event Start and End Date had time zone localization enabled, which has been removed. | If a study has Event Start or End Date enabled, and two users with more than a 12-hour time difference edited the same event, the Event Dates were saved with the second user’s timezone, which could have been a different day. | 3.17.1 |
| Removed time zone localization for Protocol Verification Date, Date Planned Start, Date Planned End under Sites. | Under Study –> Sites the following entities had timezone localization enabled: Protocol Verification Date, Date Planned Start, Date Planned End. The localization has been removed. | 3.17.1 |
| Removed time zone localization for Subject Enrollment Date | The Subject Enrollment Date had time zone localization enabled, which has been removed. | 3.17.1 |
| Removed time zone localization for event CRF date interviewed | The CRF Interview Date had time zone localization enabled, which has been removed. | 3.17.1 |
| Updated to a more clear message when disabling a rule | When a rule was disabled, the message stated, ‘If you disable this rule, it will not run in Data Entry or Bulk mode . The rule can be enabled by a principal investigator. Are you sure you want to disable it?’ | 3.18 |
| Corrected pop up message to “unfortunate event.” | The Pop up error message reads ‘unfortunate even’ instead of ‘unfortunate event’: | 3.18 |
| Fixed message on user profile when name contained special characters | Previously, on the user profile page if a name contained a specicial character the message would say: ‘Invalid character found.’. It is fixed to be more clear and now says: ‘First Name cannot contain special characters’. | 3.18 |
| Fixed issue that allowed an Occurrence of # 0 to be added. | Previously, if a user added a repeating event but did not schedule it, and then added another event, the first event would have an Occurrence # of 0. | 3.17.1 |
Captivate 3.17
Captivate 3.17 Overview – Released May 7th, 2024:
-
Starting in 3.17, we will allow Rules to be written that can compare Times in your CRF and raise appropriate alerts. This will be useful for tracking times between dosages, or times between check-ins, and so on. Times can either be bound to Dates, to track changes over multiple days, or simply set as Times alone, so as to track differences in minutes.
For more specifics, please see the detailed release notes below.
3.17 Enhancements
| Summary | Impact | Release |
|---|---|---|
| Extend rules engine to work with Date&Time items | You can now use rules with Date&Time item pairs. For example, Date&Time_2 – Date&Time_1 <= 15. | 3.17 |
| Added validation that the current stage of event CRF corresponds to the stage on the data entry page. | Previously, no validation would check that the current stage of event CRF corresponds to the stage on the data entry page when using the back button. | 3.16.7 |
| Enhanced the “View Data Entry” page to use SCD logic for items with skip logic. | On the View Data Entry page, Monitors would previously be able to view hidden items, even when the skip logic condition was not met, and would have been able to SDV those hidden items. | 3.16.1 |
| Updated default values setting character limit | When a default value was set for a text or number item, it would only allow that number of characters. | 3.16.1 |
| Number items types in dataset export as numeric in XLS report | In XLS datasets, the number of items will be exported as real numbers, i.e., 0.00. | 3.16.1 |
| Update download of query report for large volume of queries | If a study had a large volume of queries, exporting the query report would not download. | 3.17 |
| Improved the Item layout on the Print form for items in a group. | Improved the Item layout on the Print form for items in a group. /td> | 3.16.2 |
| Headers for items in a group were added to the print form. | Headers for items in a group were added to the print form. | 3.16.1 |
| Increase text size for Event Name. | Users can now name their events to x amount of characters | 3.16.7 |
| Improved performance of repeating events with a large number of occurrences | Improve performance of repeating events with a large number of occurrences | 3.16.6 |
3.17 Bug Fixes
| Summary | Impact | Release |
|---|---|---|
| Fixed issue with Audit Event Page not showing data | Fixed issue with Audit Event Page not showing data | 3.17 |
| Fixed issue with child item SDV icon | Previously, the SDV icon appears for child textboxes when SDV is set to No. Now, only the parent item has SDV icon. | 3.16.8 |
| Fixed rule issue when an item was used from a locked version. | When an item in a rule was used from a locked form version, the rule was not editable and would display an error message. | 3.16.1 |
| Fixed issue with rules in locked form versions | When an item in a rule was used from a locked form version, the rule was not editable and would display an error message. | 3.16.1 |
| Fixed issue that caused export jobs containing Treatment Group data to export inconsistently. | Fixed issue that caused export jobs containing Treatment Group data to export inconsistently. | 3.16.2 |
| Fixed issue on the Running Jobs page | Previously, Under the Running Jobs page, a study admin could see jobs running for all studies on the same cloud. It now only shows jobs for the specific studies | 3.17 |
| Fixed issue with pre-filled annotations on tables | When a user pre-filled annotations in a table, it didn’t recognize the annotations on all rows and would require a user to add another note to move on. | 3.16.1 |
| Updated Sign Logic to include hidden forms | The logic, which checks whether a study event could be signed, was not updated to ignore event forms hidden by Show/Hide Form rules. | 3.16.2 |
| The Promotion Script on Event update fails because of the forms volume | When promoting an event with a large number of forms, the promotion script pop-up was missing. The issue is resolved by increasing the promotion time. The Submit button will be disabled until the task is completed. | 3.16.2 |
| The Max Text Size limit incorrectly re-triggered for Resizable text field if limit exceeds 256 characters | Fixed issue when the max text size for resizable text item was more than 255 characters, which triggered a validation, when it shouldn’t. | 3.16.2 |
| The iFrame gets lost when saving a form that contains a hidden table with hidden items | If a user saved a form with a hidden table with no condition, the CRF vanished, and the user would have been taken to the Dashboard Page. | 3.16.2 |
| The rule didn’t not re-run after it was enabled | If a user created a rule, disabled it, and enabled it would not re-run on the same subject/event. | 3.16.2 |
| Validation only worked for the first form in the list in the Hide Form rule | If a user created a Hide Form Rule for multiple forms and then disabled one of the Forms, the rule did not run for the second form. | 3.16.2 |
| The Users could Enter Data for Locked Subject from Subject Record page | The Edit CRF button was available for locked Subjects on the Subject Record page. | 3.16.3 |
| An error occurred when exporting a filtered list of users | When exporting a filtered list of users, the export process failed. The issue is fixed. | 3.16.6 |
| The PHI data can be seen on the eCRF Data DeletionDisabling | On the Confirm DeleteDisable page, PHI was not masked. | 3.16.6 |
| Fixed Regression from 3.16.1 in dataset extraction | Regression in the 3.16.1 release that introduced an error when extracting a dataset containing multi-select items. | 3.16.4 |
| DCFs would not download if the Site ID had a comma | Fixed an issue where a comma in the Site ID prevented the DCF download from generating. This issue is fixed, and the DCF download is available for all sites. | 3.17 |
| Fixed issue for hidden forms on View Subject Page | When a form was hidden for sites, study-wide users could see it on the Subject Matrix but not on the View Subject Record page. | 3.16.8 |
Captivate 3.16
Coming soon!
3.16 Enhancements
3.16 Bug Fixes
Captivate 3.15
Captivate 3.15 Overview – Released October 17th, 2023:
-
This release focuses on system stability, data integrity, and usability improvements across Captivate.
Several issues related to repeating tables, skip logic behavior, RFC placement, and promotion workflows
have been resolved to ensure consistent and reliable data handling. -
Improvements were also made to dataset management, randomization safeguards, dashboard error handling,
and UI message rendering to prevent layout disruptions and unintended duplicate actions. -
Backend enhancements further strengthen database validation, prevent duplicate records, and improve
exception handling to reduce system-level errors.
For more specifics, please see the detailed release notes below.
3.15 Enhancements
| Summary | Impact | Release | Internal ID |
|---|---|---|---|
| SDV Editing and Data Import Control Improvements | Improved system controls related to SDV (Source Data Verification) editing and data import rules. Updates include enhancements to study-level configuration for allowing SDV data editing, and strengthened validation logic to prevent restricted data imports and rule insertions. These changes improve data integrity and provide clearer enforcement of study configuration settings. | 3.14.1 | C-1718, C-1719, C-1722, C-1723 |
| Add unique constraint to prevent database corruption of event_definition_crf table | Add unique constraint to prevent database corruption of event_definition_crf table. | 3.14.1 | C-1691 |
| Add validation trigger to prevent duplicates in event_crf database table | Add validation trigger to prevent duplicates in event_crf database table. | 3.14.1 | C-1784 |
| Add ability to configure study to always show Mark CRF Complete confirmation popup | Add ability to configure study to always show Mark CRF Complete confirmation popup. | 3.14.1 | C-1797 |
| Add table row number column to query exports | Add table row number column to query exports. | 3.14.1 | C-1798 |
| Add page messages that indicates file downloading process on SDV page | Add page messages that indicates file downloading process on SDV page. | 3.14.2 | C-1793 |
| Replace SpringController.addPageMessage (without logger) by new logic | Replace SpringController.addPageMessage (without logger) by new logic. | 3.15 | C-1701 |
| Event Start and End Date Visibility Updates | Event Start and End Dates are now hidden across Captivate in the following areas: Subject Matrix, JSP pages, Datasets, Casebook views, and related event-based interfaces. This update ensures consistent handling when event start and end dates are not enabled in the study configuration. | 3.15 | C-1660, C-1661, C-1662, C-1663, C-1664, C-1659 |
| Add explanation pop-up when user creates a query in Item level SDV form | Add explanation pop-up when user creates a query in Item level SDV form. | 3.15 | C-1685 |
| Implement changes required for transfer to Postgres 12 (without upgrading of driver version) | Implement changes required for transfer to Postgres 12 (without upgrading of driver version). | 3.15 | C-1849 |
3.15 Bug Fixes
| Summary | Impact | Release | Internal ID |
|---|---|---|---|
| Fixed: Dataset Download Link in Pop-up | Resolved an issue where the download link shown after generating a dataset was not functioning. The download link now works as expected, allowing users to successfully retrieve generated datasets directly from the pop-up. | 3.14.1 | C-1756 |
| Fixed: Duplicate Randomization Forms Created After Successful Randomization | Resolved an issue where duplicate Randomization forms could be created after using the browser back button following successful randomization. The system now correctly maintains a single Randomization form per event. | 3.14.1 | C-1786 |
| Fixed: Endless Email Loop Triggered by Dashboard Exceptions | Resolved an issue where exceptions occurring on the Dashboard triggered repeated redirection and caused email notifications to be sent in a loop. The system now prevents repeated email notifications. | 3.14.2 | C-1893 |
| Fixed: Repeating Rows with Annotations or Queries Not Removed | Resolved an issue where repeating table rows containing annotations or queries were not fully removed after deletion. Rows are now properly deleted upon saving and reopening the CRF. | 3.14.2 | C-1831 |
| Improvement: Reworked Skip Logic Changes from CAP-1710 | Reworked previous skip logic changes to ensure expected functionality and prevent unintended side effects. The updated implementation improves stability and maintains correct skip logic processing. | 3.14.2 | C-1819 |
| Fixed: ‘Null’ Displayed When Editing Datasets | Resolved an issue where editing an existing dataset displayed ‘null’ instead of the number of selected items. The correct item count now displays properly. | 3.14.2 | C-1869 |
| Fixed: Back Button Allowed Duplicate Promotions | Resolved an issue where using the browser back button on the Promotion page allowed duplicate promotions. The system now prevents repeat promotion of the same change. | 3.14.2 | C-1817 |
| Fixed: RFCs Created in Incorrect Repeating Table Row | Resolved an issue where RFCs (Queries) were created in the wrong repeating table row. RFCs now align correctly with their corresponding rows. | 3.14.2 | C-1805 |
| Fixed: Skip Logic Data Not Saving Correctly in Repeating Tables | Resolved an issue where items with skip logic set to ‘Hide’ saved data only in the first row of repeating tables. Data now saves correctly across all rows. | 3.14.2 | C-1812 |
| Fixed Bottom Scroll Bar Disappearing on Wide eCRF Forms | Resolved an issue where the horizontal scroll bar disappeared on wide eCRF forms after triggering validation messages. UI layout is now stable even when multiple messages are displayed. | 3.15 | C-1763 |
| Fixed: Coding Page Failing to Load | Resolved an issue where the Coding page failed to load due to a backend null pointer exception. The page now loads and functions correctly. | 3.15 | C-1792 |
Captivate 3.14
Coming soon!
Captivate 3.13
Coming soon!
Captivate 3.12
Coming soon!
Captivate 3.11
Coming soon!
Captivate 3.10
Coming soon!
Captivate 3.9
Coming soon!
Captivate 3.8
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Captivate 3.7
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Captivate 3.6
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Captivate 3.5
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Captivate 3.4
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Captivate 3.3
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Captivate 3.2
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Captivate 3.1
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Captivate 3.0
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