リリースノート

Available on 2024-10-08 (US servers)
Available on 2024-10-09 (Europe servers)
Available on 2024-10-17 (Japan servers)
Available on 2024-10-21 (China servers)

This release contains improvements to existing functionality, bug fixes, and the following new functionality:

• Document sharing: Viedoc Share is introduced, for viewing and signing documents shared from Viedoc TMF. Allows sharing documents with Viedoc Clinic and/or Viedoc Me users. 
• Share Viedoc Me account activation electronically: Account invitations can be shared via email and/or SMS. Available for studies using the new Viedoc Me application for demo and production sites.
• Role-based queries: Restricts query resolution to the same role that raised the query. Includes role association and filtering options and new columns in the Excel/CSV queries export output.
• Query reports: Four new query reports: Manual and validation, Manual, Validation and Pre-queries. The existing query report will be included as one of the sub-reports with the new name “Query Table”.
• Auto coding: Viedoc Coder now supports auto coding, which can be enabled on any scope using MedDRA. This version of auto coding can code an exact match in MedDRA, in any language (except MedDRA-J).
• API enhancements: Requires adding an associated role and site(s) for Web API client setup, restricting access to data visible to the role.
• Alerts in revision: Option to add and edit alerts without creating a new design version.

Download Release Notes Viedoc 4.80 (pdf) | Release Certificate | JPMA EDC Checklist | EDC管理シート

Watch the release highlights video

Release notes updated 2024-07-19

Available on 2024-06-20 (US servers)
Available on 2024-06-26 (Europe servers)
Available on 2024-08-28 (Japan servers)
Available on 2024-09-04 (China servers)

This release contains improvements to existing functionality, bug fixes, and the following new functionality:

Viedoc Coder has been updated with several new features, which are available for new studies started after the 4.79 release. For Viedoc Coder, new studies are defined as when a dictionary instance is added to a study’s scope for the first time. Later, all studies, existing and new, will be updated to use the new Viedoc Coder. This update will be communicated well in advance.

The new Viedoc Coder launches in a new browser tab and has a new look and feel for statistics on the Overview page. Access to subject data is improved which allows for easier query raising. Also, coding terms have changed to: Approve/Reject/Reset.

• Dictionary support has been updated for both MedDRA and WHODrug.
  • For MedDRA, non-current terms are shown with a warning in the results list and LLT field.
  • For WHODrug, the fields Cntr, MAH, Form, and Strength are always visible; The search result shows unique values only; The selected value is always the least specific; And ATC assignment is automatically selected if one code is present (if two or more are present, the user must manually assign the ATC code).
  • To improve searching in the dictionaries, we have made it easier to copy the text of the item to be coded, so it can be easily pasted into the search field of the coding area.
• Export of coding has rearranged columns for a better order, and all dictionary-specific items are shown together.
• You can now apply sorting to the columns, and we have removed the sequence column, providing more space.
• In the ‘Find and apply code’ section, for easier access, the comment field is now always visible.

In Viedoc Admin, the Design Revision Impact Analysis tool is introduced to let Admin users with the new system role Design Impact Analyst, see what impact a design revision will have on existing form instances before applying the revision.

A user with this role can use the new Impact analysis button on the Apply revision tab in the Design settings window to perform the impact analysis. The new revision summary column, Req confirmation, shows the number of existing form instances per site that require confirmation by site staff. The design impact analysis report can be downloaded in Excel format. Please note that before inviting a user with this role, we recommend that you read the Viedoc Admin User Guide in the Viedoc eLearning to understand when the design impact analysis report may reveal blinded information.

In Viedoc Designer, in Study settings, the following settings in a design revision can be edited: Selection View Settings, Subject ID Generation Settings, Subject status settings, eLearning settings, and Miscellaneous settings, removing the need to create a new design version for updates. The settings used are those in the latest effective design revision at a respective site.

In the Trial Master File view, in the Document properties window, a validation for the year part of the dating convention value is added, to make sure that the entered value is a valid date.

Viedoc Me has a new identity provider for user authentication, offering better support for enhanced security and centralized user management. Automatic logout will occur after a certain time of inactivity or if the network connection is lost. For more information about the automatic logout, see the Viedoc eLearning.

 The following updates to the ODM data export/import have been made to fix compatibility issues:

• Support for partial datetime, date, and time is introduced for the ODM data export. This is now the default type when exporting designs and data in ODM format. Partial dates as per the ISO 6801 standard are written up to the most detailed value available. This makes the export compliant with CDISC ODM. This is implemented in a new export version, version 4.79.
• When exporting a design to ODM, multi-selection code lists are handled as follows:
  • The checkbox item definitions are split by code list items.
  • During metadata export, checkbox ItemDef is replaced with one for each code list item.
  • For clinical data export, the comma-separated values are replaced for the checkbox with ItemData for each respective value.
  • For example, when splitting a checkbox ItemDef with OID=”CHK” and code list IDs “Yes” and “No”, the split checkbox ItemDefs will have the OIDs “__CHK__Yes” and “__CHK__No”, respectively. That is, the original OIDs and the code list IDs are prefixed with two underscore characters and separated by two underscore characters. This has been introduced to be compliant with CDISC ODM. The update is implemented in a new export version, version 4.79.
• In Viedoc Designer, checkbox items are exported as multiple ItemDefs – one for each selection value.
• In Viedoc Clinic and in the Viedoc API, in the latest export version, checkboxes are exported as separate items for metadata and clinical data. In previous export versions, checkboxes are exported as one item.
• Upon import of a design, multi-selection for code lists (checkboxes) is handled as follows: If checkbox items are found during data import, the data is combined as comma-separated values. If the checkbox data is imported as one ItemData, the structure is preserved. This has been introduced to achieve ODM-compliant designs.

Please note that if you are using the ODM format for an integration and have used the data structure version “Latest Viedoc version”, the changes to the ODM export that are implemented in a new export version will be effective in your study and might potentially affect your integration. If you instead lock the data structure version to the current version, only some of these changes will be effective in your study.

Download Release Notes Viedoc 4.79 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available on 2024-03-11 (US servers)
Available on 2024-03-14 (China servers)
Available on 2024-03-16 (Europe servers)
Available on 2024-03-23 (Japan servers)

• This release is dedicated to introducing a new identity provider for authentication of Viedoc users, offering better support for security and centralized user management. The migration of user accounts is seamless and has the same functionality as before. Users will not see any changes unless they are logged in and access their user profile.
• Users have a new page with an updated UI for managing their user account when selecting the following links: Edit your profile, Change Password, Security Settings, Show login history from Access Settings. Users can access the User Settings, the Security Settings, the Authentication Log (previously the Login history), and Change Password.
• For password recovery/resetting a password, the security question has been removed. Instead, an authentication code must be provided. The authentication code is sent to either a phone number set to receive text messages or to a secondary email address.  
• The Login History has been renamed to the Authentication Log, which provides detailed information on the actions and result of actions performed by the user for the latest login sessions.
• Please note that the list of the users trusted devices is not migrated. If the trusted devices option is selected, users will need to confirm their trusted devices at the next login.

Download Release Notes Viedoc 4.78 (pdf) | Release Certificate | JPMA EDC Checklist

Available for 2023-10-09 (Europe servers)
Available for 2023-10-06 (Japan servers)
Available for 2023-10-12 (China servers)
Available for 2023-10-26 (US servers)

This release contains improvements to existing functionality, bug fixes, and the following new functionality:

• Item-level SDV - Viedoc Admin/ Viedoc Clinic
  In Viedoc Admin, a new study setting is available: Enable item-level SDV. When this option is selected, users with SDV permission can, apply SDV to individual items in a form within Clinic. The option is deselected by default, in Viedoc Admin, for studies that started before the release of Viedoc 4.77, and selected by default for studies that start after the release of Viedoc 4.77.

• Document versioning - Viedoc TMF
  In Viedoc TMF, support for document versions have been added. The document versions will add another level of versioning on top of the file versions that aligns with the Exchange Mechanism Standard (EMS).

• Study design management – Viedoc Designer
  Support for Improved design change management by allowing the role definitions to be changed in design revisions.

• Browser Support - Viedoc Admin, Viedoc Designer, Viedoc Clinic, Viedoc Me
  The browser no longer automatically translates pages. This is to make sure that end users see correct translations.

• View roles user permissions - Viedoc Designer, Viedoc Clinic
  It is now possible in Viedoc Designer to set a user permission to view the Roles page in Viedoc Clinic. This controls the permission for which roles have access to the information provided on the Roles page. This permission is selected by default for all roles.

Download Release Notes Viedoc 4.77 (pdf) | Release Certificate | JPMA EDC Checklist

Available for 2023-06-20 (Europe servers)
Available for 2023-06-21 (Japan servers)
Available for 2023-06-22 (China servers)

This release contains improvements to existing functionality, bug fixes, and the following new functionality:

• A new setting is introduced in Viedoc Admin: The subject edit lock. When this setting is enabled in Viedoc Admin, multiple users without edit permissions (for example, monitors and data managers) can, in Viedoc Clinic, work on the same subject that is being edited by a user with edit permission (for example, an investigator or a study coordinator). For more information about the subject edit lock, see the Viedoc Admin User Guide and the Viedoc Clinic User Guide in the Viedoc eLearning.

• For security reasons, some file formats cannot be uploaded to the eTMF. For a complete list of the blacklisted file formats, see the Viedoc eTMF User Guide or the Viedoc User Guide for eTMF Managers in the Viedoc eLearning.

• The browser no longer automatically translates the eTMF pages. This is to make sure that end users are seeing the correct translations.

• The Form link item has now been introduced for Japanese PMS studies. This allows links to be created between forms containing related/dependent data for Clinic side users.  Information from different forms or booklets can be easily connected and viewed by selecting the link in a form. This can be useful, for instance, to show complementary data, for example, the AE reports can link and be submitted together with forms regarding patient background and history. Sponsor side users can receive and view forms linked to other forms.

Download Release Notes Viedoc 4.76 (pdf) | Release Certificate | JPMA EDC Checklist

Available for 2023-04-25 (Europe servers)
Available for 2023-04-26 (Japan servers)
Available for 2023-05-03 (China servers)

This release contains improvements to existing functionality, bug fixes, and the following new functionality:

• In Viedoc Designer and Viedoc Clinic, the User role avatars in Viedoc have been updated to be more broadly representative of the plurality of our users.

• In the Trial Master File view, on the Structure page, documents can now be filtered by Trial level. At the top of the filter menu, the option All documents is introduced, and Trial level is now an option on that menu. The Trial level option means that users can filter out the documents that are linked to that level only.

• In the Trial Master File view, on the Structure page, it is now possible to see when documents are being uploaded even when there are filters set. Reloading the web page no longer resets the filters.

• In the Trial Master File view, the format for date, time, and datetime is now inherited from Viedoc Admin>Study settings>Date & time format. This way, the eTMF follows the same pattern as the other Viedoc applications.

Download Release Notes Viedoc 4.75 (pdf) | Release Certificate | JPMA EDC Checklist

Available for 2023-03-07 (Europe servers)
Available for 2023-03-08 (Japan servers)
Available for 2023-03-09 (China servers)

This release contains improvements to existing functionality, bug fixes, and the following new functionality:

• Viedoc eTMF now has added support for versions 3.2.0 and 3.2.1 of the TMF reference model.
• In the Trial Master File view, the Details page has an option to save a customized selection of columns, including their positions, width, filters, and sort order. The customized selection is specific to each user. 
• In the Trial Master File view, some enhancements to the document search have been introduced. Now, when a user performs a search on the Structure page, it displays the search results with the Default option.
• In the Trial Master File view, the document preview now displays more information for zipped folders. The following is displayed: Icon + filename, date modified (in the format YYYY-mm-DD HH:MM), type, and size in kB. 
• In the Trial Master File view, the Details page now includes the columns Milestone and Milestone group.
• In TMF Admin, when maintenance mode is on, the eTMF Manager can now edit the name and the version of the instantiated structure. The name change is displayed in the Structure changes window and listed in the complete audit trail report. 
• In Viedoc Designer, the Study settings for Japanese PMS studies now include a new option: Partial Submit Setup. Enabling a Partial Submit allows the designer to configure which forms will be able to be submitted individually. Site/clinic staff and the sponsor can then manage individual forms that is, submit/receive/return/review/report forms, before all the data in the booklet is completed.  Any form in use from the current design can be selected. By default, Partial Submit Setup is disabled.
• In Viedoc Designer, for Japanese PMS studies only, the Partial Submit Setup configuration can be viewed in a separate sheet in the Complete Configuration report of the study design.
• On the Chinese instance/region, the title on all webpages have been appended with Viedoc X | Viedoc EDC where X is Admin/Clinic/Designer/TMF/Viedoc Me/Logistics/Reports.
• On the French and Japanese instances/regions the title is Viedoc X, where X is Admin/Clinic/Designer/TMF/Viedoc Me/Logistics/Reports.
• Updates to the Viedoc Web API considered as breaking changes will always be introduced in a new API version only. To ensure backward compatibility is maintained, the API version must be specified. If the API version is not specified, the latest available version will be used. Different versions can be specified at endpoint level. As of this release, there is only one API version available.
• Viedoc Reports now supports the survival package of R for custom reports. 
• We’ve enhanced and improved the user interface for displaying coding items in Viedoc Coder. You can resize columns and copy text from two columns with additional values and paste them into the dictionary search field. 

Download Release Notes Viedoc 4.74 (pdf) | Release Certificate | JPMA EDC Checklist

Available for 2022-11-29 (Europe servers)
Available for 2022-11-30 (Japan servers)
Available for 2022-12-01 (China servers)

This release contains improvements to existing functionality, bug fixes, and the following new functionality:

• In Viedoc eTMF, in the TMF Admin view, the version number of the structure is now appended to the end of the structure name instead of the “Customized” text. This change is available going forward, and the previous structure names won’t be affected.

• In Viedoc eTMF, in the Trial Master File view, the document preview now supports displaying the contents of zipped folders without having to download them.

• In Viedoc eTMF, in the Trial Master File view, the Details page now indicates deleted and inactivated zones, sections, and artifacts.

• In Viedoc eTMF, the page header and the icon on the browser tab have a new design. This is another step in the implementation of a wider UI optimization across the Viedoc suite.

• In Viedoc eTMF, in the TMF Admin view, the Settings tab has a new option under Structure: Show zone, section, and artifact numbers. When this option is selected, the Structure view in the Trials Master File view and the TMF structure page in the TMF Admin view display the zone, section, and artifact numbers and names in the same way as in the tooltip text that is displayed when hovering over them. The option is selected by default for new studies and deselected by default for existing studies.

• In Viedoc eTMF, in the Trial Master File view, for Excel and CSV exports from the Details page, the file name of the generated file has been updated to be more informative. The file name is now StudyName_DetailsPage_YYYYmmDDHHMMSS. The timestamp is in UTC format. For Excel files, the included sheet name is now Details page.

• In Viedoc eTMF, in the Trial Master File view, the Details page now includes the dating convention and the dating convention value in separate columns.

• In Viedoc Admin, when sending email alerts with an attachment, it is now possible for Study Managers to enable password protection for the attached files.

• In Viedoc Clinic, if the option to enable password protection for alert email attachments has been selected for a study, Clinic users will need the password provided by the Study Manager to open the attachments.

• There is one new known limitation for Viedoc eTMF: For security reasons, the document preview in the Trial Master File view does not support ActiveX components.

• There is one new known limitation for the Documentation and Training in Viedoc Clinic: When downloading a PDF of the Viedoc User Training Certificate, the generated PDF is limited to two pages. This means that when there are more training sections completed than can fit onto two pages, the PDF will not generate a third page and some of the training sections will be missing.

Download Release Notes Viedoc 4.73 (pdf) | Release Certificate | JPMA EDC Checklist

Available for 2022-11-01 (Europe servers)
Available for 2022-11-02 (Japan servers)
Available for 2022-11-07 (China servers)

This release contains improvements to existing functionality, bug fixes, and the following new functionality:

• Viedoc Reports now has a modernized user interface. This is another step in the implementation of a wider UI optimization across the Viedoc suite. Also in Viedoc Reports, there is a new option in settings, which allows users to customize the page appearance by selecting to view the page in either light mode or dark mode. Due to the rise in popularity of the Viedoc Reports application, very large amounts of data are handled in the data sync. To reduce the response times, the daily data sync now operates on production data only. To sync demo data, use the on-demand sync option.

• As of Viedoc version 4.71, the design version is printed on each page of the PDFs generated (annotated CRF, blank CRF, workflow, and configuration report) from Viedoc Designer. This is so users can easily identify which design version the respective settings belong to. In Viedoc Designer, improvements to the validation have been made to check for duplicate IDs, regardless of casing.

• In the Study settings dialog, users can now generate and download the Admin audit trail report from the new Logs tab. The report contains information about all settings and changes of study settings that have been made by authorized users in Viedoc Admin. For a detailed description of the contents of the report, see the Viedoc Admin User Guide in the eLearning.

• It is now possible to use the Web API to retrieve user information in a study. It’s also now possible to invite multiple users to different roles simultaneously through the Web API. Further, it is now possible to use the Web API to add a list of additional properties for specific users.

• In Viedoc Clinic, it is now possible to search by Subject ID using the ‘Subject key’ parameter. This is a much faster search parameter than the ‘All data’, which must be selected to run. ‘Subject key’ is now the default search parameter. Also, the user can now cancel an ongoing search. Further, it is now possible to receive the form PDF attached to the alert email if configured in the study design.

• In accordance with our UI optimization process, we have updated the look of the sign-in page, as well as the sign-up process.

Note!
Release Notes Viedoc 4.72 updated 2022-10-31. The sections ”New and updated functionality” and “Bug fixes” were updated to remove the updates for designer validation regarding the duplicated IDs.

Download Release Notes Viedoc 4.72 (pdf) | Release Certificate | JPMA EDC Checklist

Available for users on 2022-06-16 (Europe servers)
Available for users on 2022-06-23 (Japan servers)
Available for users on 2022-06-23 (China servers)

This release contains improvements to existing functionality, bug fixes, and the following new functionality:

• A powerful new function for displaying, sorting, and filtering documents by their metadata is introduced to Viedoc eTMF. The Details page is available to all users of the Trial Master File view, and it can show all the documents that a user has access to. When the document data has been filtered, sorted, and arranged according to the users’ settings, they can perform an export that exactly reflects their view.

• In Viedoc Reports, a new PMS dashboard report is introduced as a standard report for Japanese PMS studies as well as a new Dashboard page. The PMS dashboard report allows data to be sorted to focus on the booklet status by site, subject, booklet, booklet history, or timelapse. The Dashboard page gives snapshots of the registration and study progress with terms specific to Japanese PMS studies, such as Registration status, Booklets initiated, the date of the first booklet for the first subject, and a last subject last booklet marker, estimating the date of the last submitted booklet for the last subject.

• In Viedoc Admin, the API configuration has two tabs – a new tab for Web API client where users can add new Web API clients and edit or delete existing ones. There is also a tab for WCF API client (which has the same functionality as the previous version of the API configuration).

• An optimized user interface is introduced for Viedoc Me. Study managers can select, for both production and training sites, which Viedoc Me interface trial patients will interact with. The new interface allows subjects to minimize and maximize the Viedoc Connect window during an ongoing call and also to navigate to other Viedoc Me pages and fill in forms while in a call on Viedoc Connect. There is also a new button notification that alerts the user when there is an active video call from anywhere in the app. The user can click on the button at any time from any page within the application to join a call.

• Two new options for the Study settings in Viedoc Admin for PMS studies are introduced and are set to either mandatory or optional – Require Contract for booklet submission and Require Responsible Investigator for booklet submission. When these are selected, in Viedoc PMS, the Submit booklet dialog has fields for Contract and Responsible Investigator. If the options for linking the booklet to Contract and Responsible Investigator are selected in Viedoc Admin, the Excel export for PMS studies will contain two new columns on the Booklet status sheet: Contract Number and Responsible Investigator.

• The Viedoc Web API now has the possibility to create and invite users. Contracts, Sites and User properties can be added through the Viedoc Web API and are included in the ODM formatted data export. 

• There is one new known limitation: In Viedoc Admin: Date Format- the following date formats are known to cause issues in study settings, please do not use them:
  1. d/M/yyyy
  2. dd/MM/yyyy
  3. dd.MM.yyyy
  4. dd M yyyy
  5. dd MM yyyy

Note!
Release Notes Viedoc 4.71 updated 2022-06-21. Added known limitation for Viedoc Me.
Release Notes Viedoc 4.71 updated 2022-06-13. Revised section Bug fixes, updated with 3 additional bugs.

Download Release Notes Viedoc 4.71 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2022-05-06 (Europe servers)
Available for users on 2022-05-10 (Japan servers)
Available for users on 2022-05-12 (China servers)

This release contains improvements to existing functionality, bug fixes, and the following new functionality:

• A form link item is introduced to Viedoc Clinic, allowing links to be created between events and forms. This means that information from different forms or events can be easily connected and viewed by clicking the link in a form. This can be useful, for instance, to show the reason(s) why a particular concomitant medication was taken by a subject and when it was taken. Different events, such as an Adverse event or a Medical History event, can be linked to the concomitant medication, as well as items from these forms.
• In Viedoc eTMF, a document preview is now available for documents in the drop zones. It allows users with read permission to view the file in the browser, without downloading it. The preview shows the latest version of a document, side by side with its metadata. No files are stored on the user’s computer when previewing, which can be helpful in avoiding storing potentially sensitive data on the hard drive.
• Two new standard reports are included in Viedoc Reports. The Overdue Events Report shows events that have the Proposed date and Event Window End Date set to a past date. The data in this report can be grouped by country, site, subject, event, or by the past proposed date. This report is also included as part of the Key risk indicator report. The Form Status Report allows users to see an overview of the status of forms, for example, initiated, pending, (and triggered which includes both initiated and pending forms), saved with issues, signed, unsigned, or completed. The data in this report can be grouped to show the numbers of forms with the above status as well as the progress of form initiation as a percentage for initiated forms and triggered forms.
• In Viedoc Reports, as part of the Key risk indicator report, two new reports are included: The Pending forms per subject report calculates the average number of pending forms for each subject and is included in the following subreports: Overview, by Site, by Key Risk Indicators. The site value is the average number of pending forms per subject for each site. The Rejected queries per subject report calculates the number of rejected queries for each subject and is included in the following subreports: Overview, by Site, by Key Risk Indicators. The Site value is the average number of queries with query status as rejected per subject for each site.
• Three different Communication logs are now available to view and download for SMS and emails in Excel file format.
  1. In Viedoc Admin, the study-specific User Communication Log (for Study/Site Managers and Investigators). This log contains the following communication related to a study: Alerts, Invitation to a specific role within a study, Notifications (study access deletion).
  2. In Viedoc Admin, the user-specific Communication log, (for Study/Site Managers and Investigators) which is accessed on a new Communication Log tab in User settings. The Communication Log tab shows: date and time, type of message and message status and displays the latest 20 rows of the log. The Communication logs file contains information about all SMS and emails to the study users that are unrelated to a specific study, such as: Reset password, verification, and notifications (for example changing a telephone number or email address), two-factor authentication (email/ SMS).
  3. In Viedoc Clinic, the subject-related Communication log (for Investigators). This Communication log contains information about all emails and SMS communication sent to the subject. In a subject’s Viedoc Me account a new subject-related Communication log is added as a separate sheet to the ViedocMeLog Excel file that is downloaded from the ViedocMe account Status page. This includes message ID, the Viedoc username (user account), communication type (email/SMS), message type (reminder, date and time of the communication), site type (training/production), the status of the message (success/failed) and the provider name used to send the communication to the recipient (this information is used if needed for troubleshooting purposes).

Note!
Release Notes Viedoc 4.70 updated 2022-05-02. Revised sections New functionality & Updated functionality.

Download Release Notes Viedoc 4.70 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2022-02-10 (Europe servers)
Available for users on 2022-02-10 (Japan servers)
Available for users on 2022-02-16 (China servers)

This release contains improvements to existing functionality, bug fixes, and the following new functionality:

• Asymmetric encryption is introduced to Viedoc Clinic and Viedoc Me. This is to ensure that stored encrypted subject contact information such as email addresses and phone numbers stays secure and cannot be easily decrypted by a hostile third party when sending emails/SMS. When Viedoc sends an email/SMS, it will now send these to the external service to decrypt and send the email/SMS.
• In Viedoc eTMF, a status tab is introduced, making it possible to lock the eTMF to prevent changes from being made to the data at the time of archiving. The status tab shows the TMF status and the location for locking/ unlocking the study eTMF. All status tab changes of the eTMF are included in the audit trail.
• Two new standard reports are included in Viedoc Reports. The Medical Coding Report lists all the medical coding data along with the "Unique Term Reports" for each coding dictionary. The Disposition Report lists event level summary (study, country, site) and disposition level summary (study, country, site) along with relevant plots.

Download Release Notes Viedoc 4.69 (pdf) | Release Certificate | JPMA EDC Checklist [updated 2022-03-16]

Watch the release highlights video

Available for users on 2021-11-25 (Europe servers)
Available for users on 2021-11-24 (Japan servers)
Available for users on 2021-11-25 (China servers)

This release contains improvements to existing functionality, bug fixes, and the following new functionality:

• Viedoc Connect – our telemedicine solution that enables meetings between Clinic and ViedocMe users through video calls.
• A drawing pad item that allows the subjects to make drawings in ViedocMe.
• A new view in the Selection page showing a quick overview of the event status for all subjects.
• Support for sharing files through Drop zones in eTMF.
• eTMF archive can now be generated from the TMF Archive view via proper user permissions.
• “Visit” is replaced with the term “Event” throughout the system and eLearning. “Unscheduled events” in Viedoc Clinic is renamed to “Common events” to align with industry terminology and Viedoc Designer.

Download Release Notes Viedoc 4.68 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2021-09-05 (Europe servers)
Available for users on 2021-09-05 (Japan servers)
Available for users on 2021-09-06 (China servers)

This release contains improvements to existing functionality, bug fixes, and the following new functionality:

• Support for approving the medical coding directly in the Medical coding console.
• Two optional columns are introduced in the Medical coding console that shows supporting values when coding, for example “route” and “indication”.
• Scheduled data exports are introduced via an export application.

Download Release Notes Viedoc 4.67 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2021-06-10 (Europe servers)
Available for users on 2021-06-10 (Japan servers)
Available for users on 2021-06-11 (China servers)

This release contains improvements to existing functionality, bug fixes, and the following new functionality:

• A visit reminder function is introduced in the Study event settings for sending out reminders if events have not been completed.
• New study event statistics variables are introduced that can be used in expressions when designing forms and/or alerts.
• Custom reports are introduced. Users can now write R programs that generate report tables based on CRF and operational data and upload them into Viedoc Reports.

Note!
Release Notes Viedoc 4.66 updated 2021-06-07. Revised sections Updated functionality & Known limitations.

Download Release Notes Viedoc 4.66 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2021-04-29

This release contains improvements to existing functionality, bug fixes, and the following new functionality:

• A user administration log report in Excel format, containing a log of the roles and users in the study with access and certification information.

Download Release Notes Viedoc 4.65 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2021-03-28

This release contains improvements to existing functionality, bug fixes, and the following new functionality:

• Viedoc eTMF, a new, fully integrated digital repository for capturing, managing, sharing, and storing essential documents for your clinical trial. Viedoc eTMF is based on the TMF Reference Model by the Drug Information Association (DIA). The TMF Reference Model categorizes documents in zones, sections, and artifacts in a hierarchical structure and includes documents in all different phases of a clinical trial.
• Viedoc Designer is improved with a new JavaScript expression editor, making it easier and clearer to write expressions.

Note!
Release Notes Viedoc 4.64 updated 2021-03-25. Revised section Known limitations.

Download Release Notes Viedoc 4.64 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2021-02-04

This release contains improvements to existing functionality, bug fixes, and the following new functionality:

• Viedoc Reports, a new, fully integrated application for viewing and analyzing study progress and performance. Viedoc Reports allows you to easily browse your data and illustrate it in reports and graphs. The data is collected from your Viedoc study according to your design, and the information is updated every 24 hours. Viedoc Reports also includes a new eLearning curriculum.
• In Viedoc Clinic, the data export now has an option to include pending forms when exporting in Excel/CSV format.

Download Release Notes Viedoc 4.63 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2020-12-10

This release contains improvements to existing functionality, bug fixes, and the following new functionality:

• Settings for new applications (Viedoc eTMF and Viedoc Reports)

Download Release Notes Viedoc 4.62 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2020-10-08

This release contains improvements to existing functionality, bug fixes, and the following new functionality:

• Complete configuration report in Excel format in Viedoc Designer
• New API method for fetching clinical data without the need to get site codes from another source

Download Release Notes Viedoc 4.61 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2020-08-27

This release contains improvements to existing functionality, bug fixes, and the following new functionality:

• Download VIRP in Viedoc Admin
• Masking of data in Viedoc Clinic

Download Release Notes Viedoc 4.60 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2020-06-04

This release contains improvements to existing functionality, bug fixes, and the following new functionality:

• Expiry date and expiry period in Logistics
• Single sign-on, which is set up in Admin and then applies to Clinic users

Note!
Release Notes Viedoc 4.59 updated 2020-06-02. Revised section Known limitations.

Download Release Notes Viedoc 4.59 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2020-04-23

This release contains improvements to existing functionality, bug fixes, and the following new functionality:

• Data export templates in Clinic
• Kit status Quarantine in Logistics
• Alert emails in Logistics

Download Release Notes Viedoc 4.58 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2020-03-12

This release contains improvements to existing functionality, bug fixes, and the following new functionalities:

• A ViedocMe overview page in Clinic
• An export function in Logistics

Download Release Notes Viedoc 4.57 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2020-01-30

Viedoc 4.56 release introduces the new feature Viedoc Logistics, enhacements to ViedocMe, and bug fixes.

Note!
Release Notes Viedoc 4.56 updated 2020-01-27. Revised sections Updated functionality and Bug fixes.

Download Release Notes Viedoc 4.56 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2019-11-14

Viedoc 4.55 release is a maintenance release that consists mainly of enhancements and bug fixes.

Download Release Notes Viedoc 4.55 (pdf) | Release Certificate | JPMA EDC Checklist

Available for users on 2019-10-17

Viedoc 4.54 is a maintenance release that consists of a set of enhancements and bug fixes.

Download Release Notes Viedoc 4.54 (pdf) | Release Certificate | JPMA EDC Checklist

Available for users on 2019-08-29

Viedoc 4.53 is a maintenance release that consists of a set of enhancements and bug fixes.

Download Release Notes Viedoc 4.53 (pdf) | Release Certificate | JPMA EDC Checklist

Available for users on 2019-06-30

Viedoc 4.52 introduces the following new functionality:

• Advanced allocation.
• Emergency unblinding.

Note!
Release Notes Viedoc 4.52 updated 2019-06-30. Updated Bug fixes and Known limitations list.
Release Notes Viedoc 4.52 updated 2019-07-02. Added Updated functionality section.

Download Release Notes Viedoc 4.52 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2019-05-16

Viedoc 4.51 introduces the following new functionality:

• Documentation and Training.
• Copy form from previous visit.
• PMS – Medical coding on sponsor side.
• PMS – Reset forms.

Note! Release Notes Viedoc 4.51 updated 2019-05-15. Minor editorial correction.

Download Release Notes Viedoc 4.51 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2019-04-05

The main new functionality in Viedoc 4.50 release is the Organization specific eLearning.

Note! Release Notes Viedoc 4.50 updated 2019-03-29. Updated Bug fixes list.
Note! Release Notes Viedoc 4.50 updated 2019-04-04. Updated release date.

Download Release Notes Viedoc 4.50 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2019-03-14

Viedoc 4.49 is a maintenance release that consists of a set of enhancements and bug fixes.

Download Release Notes Viedoc 4.49 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2019-02-21

Viedoc 4.48 introduces the following new functionality:

• Unlock forms within subject initiated events (ViedocMe)
• PMS: Adverse Event (AE) report management

Download Release Notes Viedoc 4.48 (pdf) | Release Certificate | JPMA EDC Checklist

Available for users on 2018-12-06

Viedoc 4.47 introduces the following new functionality:

• Support for Japanese Post-Marketing Surveillance (PMS) studies
• Automatic event date
• Maximum number of subjects per site

Download Release Notes Viedoc 4.47 (pdf) | Release Certificate | JPMA EDC Checklist

Available for users on 2018-11-15

Viedoc 4.46 introduces a completely new eLearning that provides a more comprehensive user guide with detailed step-by-step instructions and more images and examples.

Download Release Notes Viedoc 4.46 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2018-10-04

Viedoc 4.45 is a maintenance release that includes a set of issue fixes and back-end enhancements.

Download Release Notes Viedoc 4.45 (pdf) | Release Certificate | JPMA EDC Checklist

Available for users on 2018-08-26

Viedoc 4.44 is a maintenance release that includes a set of issue fixes, back-end enhancements and improvements in the process of approving pending role invitations.

Download Release Notes Viedoc 4.44 (pdf) | Release Certificate | JPMA EDC Checklist

Available for users on 2018-06-24

Viedoc 4.43 is a maintenance release that includes a set of issue fixes and back-end enhancements. Besides that, the main updated functionalities in this release are:

• Improvements to the study and role invitation process
• Update in the Data import application

Download Release Notes Viedoc 4.43 (pdf) | Release Certificate | JPMA EDC Checklist

Available for users on 2018-05-27

The main new functionalities in this release are:

• Delete study
• View study access
• Approve/Reject study invitation(s)
• Remove user role(s) and user account

Download Release Notes Viedoc 4.42 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2018-04-24

Viedoc 4.41 is a maintenance release that includes a set of issue fixes and back-end enhancements. Besides that, the main updated functionalities in this release are:

• The study lock report summary shows the number of training sites until the first production site is added. After that, it shows the number of production sites only.
• The phone number is now excluded from the roles and users pdf report.
• Event scheduling settings and repeating forms are now included in the study workflow pdf.
• The PDF export contains now only subjects/sites in demo mode or only subjects/sites in production mode, depending on which operation mode is set for the respective study (demo/production).

Note! Release Notes Viedoc 4.41 updated 2018-04-16. Updated release date.

Download Release Notes Viedoc 4.41 (pdf) | Release Certificate | JPMA EDC Checklist

Available for users on 2018-03-15

The main new functionalities in this release are:

• Two-factor authentication.
• Multiple email addresses for a user.
• New system role – API Manager.
• Option to export to PDF in FDA compliant format.
• Option to export PDF/A compliant archives.

Note! Release Notes Viedoc 4.40 updated 2018-06-15. Updated section "Updated functionality".

Download Release Notes Viedoc 4.40 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2018-01-25

The main new functionalities in this release are:

• Advanced event and activity scheduling
• Repeating forms
• Multiple reminders
• Export and API using a specific Viedoc version data structure

Download Release Notes Viedoc 4.39 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2017-11-23

Viedoc 4.38 is a maintenance release that includes a set of issue fixes and back-end enhancements. Besides that, the main updated functionalities in this release are:

• Reference ID
• Data import:
  • possibility to set character encoding in data import application.
  • possibility to set delimiter in data import application.

Non-functional updates:

• Medical coding – changed dictionary name from WHO DD to WHODrug
• ViedocMe – changed term from Questionnaires to Events, in order to align the terminology with the one used in Viedoc Clinic

Note! Release Notes Viedoc 4.38 updated 2017-11-20. Updated known limitations list.

Download Release Notes Viedoc 4.38 (pdf) | Release Certificate | JPMA EDC Checklist

Available for users on 2017-10-09

The main new/updated functionalities in this release are:

• Alerts and trackers
• Medical coding – improved search options
• Medical coding – display active ingredients in WHO DD dictionary
• Medical coding – preferred and drug name are included in the export for WHO DD
• In Viedoc Clinic, if a subject is being edited by another user, this is marked on the subject card with the username and user ID of the user who is editing the subject
• Option to prevent future dates in Date item
• Option to include/exclude the subject initiated events in Viedoc Clinic
• System checks are included in the Outputs and validation summary in Viedoc Designer
• New options for the VAS Scale item so that it can be configured for the EQ5D questionnaire
• Max file size for the file upload is now 512 MB

Non-functional updates:

• Medical coding – updated disclaimer

Note! Release Notes Viedoc 4.37 updated 2017-10-05. Updated the release date and section Alerts and trackers.

Download Release Notes Viedoc 4.37 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2017-08-24

The main new functionalities in this release are:

• Reference data
• Range item

Download Release Notes Viedoc 4.36 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2017-06-01

The main new functionalities in this release are:

• Print study workflow in Viedoc Designer
• New export format for Excel and CSV outputs, as one row per item, with the possibility to include the full history of CRF data as well
• File upload in ViedocMe

Download Release Notes Viedoc 4.35 (pdf) (updated 2017-05-31) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2017-04-20

The main new functionality in this release is:

• Support for file upload

Download Release Notes Viedoc 4.34 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2017-03-09

The main new functionalities in this release are:

• Support for a VAS scale in ViedocMe
• Support for additional data types in ViedocMe
• Configurable password expiration time in Viedoc

Download Release Notes Viedoc 4.33 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2017-01-29

The main new functionalities in this release are:

• Support for export of queries, data review status and medical coding to CDISC ODM format
• Support for fetching queries, data review status and medical coding in CDISC ODM format through the API

Download Release Notes Viedoc 4.32 (pdf) | Release Certificate | JPMA EDC Checklist

Watch the release highlights video

Available for users on 2016-12-12

The new functionalities in this release are:

• Automatic creation of groups of sites
• Support for entry of a reference ID that serves as a license key for the study

Download Release Notes Viedoc 4.31 (pdf) | Release Certificate | JPMA EDC Checklist

Available for users on 2016-11-17

The main new functionality in this release is:

• Support for data import

Note! Release Notes Viedoc 4.30 updated 2016-12-21. Added a bullet explaining the new behavior of Alert emails in chapter Updated functionality.

Download Release Notes Viedoc 4.30 (pdf) | Release Certificate | JPMA EDC Checklist

Available for users on 2016-10-10

The new functionalities in this release are:

• Dynamic randomization
• Support for unscheduled and common events in ViedocMe

Download Release Notes Viedoc 4.29 (pdf) | Release Certificate | JPMA EDC Checklist

Available for users on 2016-08-25

The new functionalities in this release are:

• Medical coding: additional dictionary support
• Export in CDISC ODM format
• API extended with method: GetClinicalData

Download Release Notes Viedoc 4.28 (pdf) | Release Certificate | JPMA EDC Checklist

Available for users on 2016-06-16

The new functionalities in this release are:

• Date & Time CRF item added
• The ability to define default values for CRF items
• Extended export

Download Release Notes Viedoc 4.27 (pdf) | Release Certificate | JPMA EDC Checklist

Available for users on 2016-05-19

The new functionalities in this release are:

• Medical coding: additional dictionary support
• Additional system languages

Download Release Notes Viedoc 4.26 (pdf) | Release Certificate

Available for users on 2016-04-18

The new functionalities in this release are:

• Medical coding part II
• Reminders in ViedocMe
• Paging on selection page

Download Release Notes Viedoc 4.25 (pdf) | Release Certificate

Available for users on 2016-03-31

The new functionalities in this release are:

• Global design settings
• Medical coding part I

Download Release Notes Viedoc 4.24 (pdf) | Release Certificate

Available for users on 2016-02-25

The main new functionality in this release is:

• Read-only settings

Download Release Notes Viedoc 4.23 (pdf) | Release Certificate

Available for users on 2016-01-28

The new functionalities in this release are:

• Issue listing
• Additional system language

Download Release Notes Viedoc 4.22 (pdf) | Release Certificate

Available for users on 2015-12-16

The new functionalities in this release are:

• Viedoc API extension
• Additional system languages

Download Release Notes Viedoc 4.21 (pdf) | Release Certificate

Available for users on 2015-11-19

The new functionalities in this release are:

• Study lock
• Role visibility on form level
• User role listing report
• Unique study mode
• Confirm “All fields”
• No reason is needed when confirming that data is missing
• Visibility condition for Activities within Common Events
• Additional study settings

Download Release Notes Viedoc 4.20 (pdf) | Release Certificate

Available for users on 2015-10-22

The main new functionalities in this release are: 

• PDF Export
• User role listing
• Delete subject
• Delete unscheduled visit
• Reset scheduled visit

Download Release Notes Viedoc 4.19 (pdf) | Release Certificate

Available for users on 2015-09-24

The main new functionalities in this release are: 

• Detailed metrics on subject status
• Patient account lock notification

Download Release Notes Viedoc 4.18 (pdf) | Release Certificate

Available for users on 2015-08-27

The main new functionalities in this release are: 

• Detailed metrics
• Permission to view metrics

Download Release Notes Viedoc 4.17 (pdf) | Release Certificate

Available for users on 2015-07-02

The main new functionality in this release is: 

• Metrics

Download Release Notes Viedoc 4.16 (pdf) | Release Certificate

Available for users on 2015-06-04

The four main new functionalities in this release are: 

• Link to eLearning
• Export preview and graphs
• Alerts
• OID and Labels

Download Release Notes Viedoc 4.15 (pdf) | Release Certificate

Available for users on 2015-05-07

The five main new functionalities in this release are: 

• Enhanced workflow design
• Design validation
• Password expiration time and password history
• Duplicate form
• Selection View settings

Download Release Notes Viedoc 4.14 (pdf) | Release Certificate

Available for users on 2015-04-09

The three main new functionalities in this release are: 

• SAS Export
• Formats
• Design configuration report

Download Release Notes Viedoc 4.13 (pdf) | Release Certificate

Available for users on 2015-03-18

The four main new functionalities in this release are: 

• Messages
• Reset / Delete forms
• Design revisions
• Batch upgrade of design revisions

Download Release Notes Viedoc 4.12 (pdf) | Release Certificate

Available for users on 2014-12-19

The two main new functionalities in this release are: 

• The addition of an Application Programming Interface (API) to Viedoc 4 
• The first stage of support for Risk Based Programming (RBM)

Download Release Notes Viedoc 4.11 (pdf) | Release Certificate

Available for users on 2014-11-11

The main new functionality in this release is the addition of randomization to Viedoc 4.

Download Release Notes Viedoc 4.10 (pdf) | Release Certificate

Available for users on 2014-10-10

This release contains improvements to existing Viedoc functionality as well as new functionality.

Download Release Notes Viedoc 4.9 (pdf) | Release Certificate

Available for users on 2014-09-21

This release contains improvements to existing Viedoc functionality as well as new functionality.

Download Release Notes Viedoc 4.8 (pdf) | Release Certificate

Available for users on 2014-08-06

This release contains improvements to existing Viedoc functionality as well as new functionality.

Download Release Notes Viedoc 4.7 (pdf) | Release Certificate

Available for users on 2014-06-07

This release contains improvements to existing Viedoc functionality as well as new functionality.

Download Release Notes Viedoc 4.6 (pdf) | Release Certificate

Available for users on 2014-05-02

This release contains improvements to existing Viedoc functionality as well as new functionality.

Download Release Notes Viedoc 4.5 (pdf) | Release Certificate

Available for users on 2014-03-24

This release contains improvements to existing Viedoc functionality as well as new functionality.

Download Release Notes Viedoc 4.4 (pdf) | Release Certificate

Available for users on 2014-02-19

This release contains improvements to existing Viedoc functionality as well as new functionality.

Download Release Notes Viedoc 4.3 (pdf) | Release Certificate

Available for users on 2013-11-20

This release contains improvements to existing Viedoc functionality as well as new functionality.

Download Release Notes Viedoc 4.2 (pdf) | Release Certificate

Available for users on 2013-10-25

This release contains improvements to existing Viedoc functionality as well as new functionality.

Download Release Notes Viedoc 4.1 (pdf) | Release Certificate

Available for users on 2013-10-02

This is the first public release of major version 4. 

This is not an upgrade but a complete rewrite of Viedoc including a new GUI and framework to support modern browsers and devices. Studies running on major version 3 must be migrated if upgrade to major version 4 is desired.

Download Release Notes Viedoc 4.0 (pdf) | Release Certificate