This feature brief describes what's coming in the 18.2 release of goBalto Activate. We've included the following sections:
- Contract management
- Site experience
- Site attributes
- Country profile
- IP release
- API integration
- Other Activate enhancements
- Implementation planning checklist
- For tips on rolling out these features to your organization, see the Implementation Planning checklist and contact your goBalto project manager for more information.
- The list of supported browsers has not changed with the 18.2 release. For details, see the goBalto Browser support article.
- This brief gives you early insights into the upcoming Activate release. All features are subject to change upon release.
We made multiple enhancements to the Contract management feature to improve reporting, capture additional information, and simplify user workflows. Functional improvements and bug fixes ensure that unique budgets, contract language, and amendments are properly captured and stored for sites that have multiple contract types. Alerts now default to “All my roles” when bulk work users select Amend all contracts within a country or all matching contracts within a country.
Accounts can now be configured to enable capture of contract and contract budget metadata. New metadata fields include allocated number of patients, per subject cost, and currency, among others.
In enabled accounts, users can select one or more contract amendment reason(s) from a preconfigured list in bulk work and in the contract itself, and accounts can now be configured to enable capture of contract and budget metadata. Users who have self-service corrections enabled may edit the metadata from within any completed contract or budget. Users in enabled accounts can now also capture whether a contract has a Master Service Agreement (MSA) or not.
With the 18.2 release, Activate introduces Submission enhancements that allow for capture of additional data and improved workflows. We relabeled the More menu “Expiring documents” option to “Expiring items,” and users who select this option can view expiring documents or filter the view to submissions, if preferred. Submissions can now be configured to capture expiration dates, with optional expiry notification (default 90 days). We also modified the Submission reason/description text field to display as two separate fields.
Activate also introduces an enhancement that allows users with appropriate permissions to update and/or delete submissions and/or submission packages.
In enabled accounts, users may now select an Agency and/or Adjustment reason from preconfigured lists. Users in enabled accounts can also enter an IRB/Ethics committee meeting date, if any, or specify no meeting date, if appropriate.
We enhanced site experience to clarify login/logout behavior for CRO/Sponsor and site users who access Activate via SSO and to support custom welcome email messaging for new site user accounts. Login/logout behavior and site user welcome messaging is enabled at the account level.
Activate introduces these additional site experience enhancements with the 18.2 release:
- Preview of Box-supported files types in site experience Notes and Activate LITE
- A Notes category selected by a site experience user now displays in Notes history
- CRO/Sponsor users who upload files can now optionally share files with site users
We enhanced site management functionality to improve usability and capture additional site data, including site staff contact information. If enabled by your account, new site data (Network, IRB name, PI credentials, PI designation) can be added or updated via the study site API or by Activate users. If enabled, site network is a sortable attribute on the site display at country level. Also, if enabled by your account, dates can be created via API for baseline, planned, and/or actual SIV dates.
With release 18.2, Activate also introduces a site management enhancement that allows users who have read only permissions to view site and site staff information (e.g., name, email, and phone).
To improve efficiency and speed the SSU process, Activate 18.2 introduces enhancements that allow enabled accounts to display country status labels in the user interface and have certain country status labels automatically flow down to country sites when appropriate. Customers can also choose to turn off certain preconfigured status labels, if preferred. Activate users who have appropriate permissions may edit a country’s status label. Additionally, country status can now be added via API.
Activate introduces IP release enhancements that allow users in enabled accounts to manage the IP release review process at the country level as well as the previously available site level. Configuration Designer users can add a country-level IP release package triggered by country creation, workflow wizard, and pre-IP release.
A new country-level “Review Activities” tab leads to a redesigned modal with separate study, country, and PI/Site document sections. Additionally, when country-level document approval is complete, users see a new icon on the site-level Review Activities list and the Define IP Release Package pages at the study and country document levels.
With Activate 18.2, we made enhancements to simplify API data exchange, support additional fields, and introduce a new API:
- artifact GET API - updated IP release package label to clarify the artifact type and added the email address of the staff member who completed the artifact
- assignments API - URL migrated to goBalto’s base API URL
- country POST and GET APIs - added country status field
- study site POST, PUT, and GET APIs - updated to include IRB Name, Site Network, PI credentials, and PI designations fields
- user API - restricts results to 10 per page
- a new activity PUT API allows an IRB to send documents in to Activate
Submission event and site level publish messages have also been updated include new fields, and the event message Message & Response page now displays the URL to which a message transmitted.
Other Activate enhancements
Additional enhancements are part of the 18.2 release and some of these items include:
- Activate users who have appropriate permissions can now navigate to the new goBalto Help Center to access goBalto product documentation and tutorials. This link displays when users hover over their name at the top right corner of any page in Activate 18.2. Previously, the link was labeled “Online help” and directed users to the goBalto U Help & Training site. goBalto U will continue to be available until further notice for release 18.1 and prior documentation.
- If enabled for your account, when creating a Note, site experience users can now select a Note type from a preconfigured list. Previously, note type was available only on activities for site users.
- Users who view a document artifact at country and/or site level that has already been added via study library will now see a new tooltip "Versions added at this level will override additional lineage document versions shared from the study library."
- A new annotation icon that displays next to any document that contains annotations, and documents that include annotations include an annotation count.
- Contract activities displayed in the bulk activities grid now have “C” contract icon preceding the activity.
Implementation planning checklist
Follow up with your Project Manager to learn how the features in the table below may be used with existing studies.
|Additional configurations?||Can be turned on and off?||Impacts UI if turned off?|
|Contract management enhancements|
|Contract types in workflow wizard|| yes
|Contract amendment reason list||yes||yes||yes|
|Contract and contract budget metadata||yes||yes||yes|
|Edit contract or budget metadata permission||yes||yes||yes|
|Capture contract MSA||yes||yes||yes|
|"All my roles" default||no||no||n/a|
|Define submission package date||no||no||n/a|
|More menu "Expiring items"||no||no||n/a|
|Submission expiry date and expiry notice||yes configuration designer||yes||yes|
|Submission reason and submission description field update||no||no||n/a|
|Select Agency from list||yes||yes||yes|
|Enter IRB/Ethics committee meeting date||yes||yes||yes|
|Enter Adjustment reason||yes||yes||yes|
|Corrections tab relabeled documents to items||no||no||n/a|
|Delete submission or submission package permission||yes||yes||yes|
|Correct attachments permission||yes||yes||yes|
|Site experience enhancements|
|Login via SSO behavior||yes||yes||yes|
|Logout URL direct||yes||yes||no|
|Preview Box-supported file type||no||no||n/a|
|Note category in note history||no||no||n/a|
|Share file with site||no||no||n/a|
|Site attributes enhancements|
|Site UI redesign||no||no||n/a|
|Additional profile data (network, IRB name, PI credentials, PI designation) via API or within Activate||yes||yes||yes|
|Display SIV dates on site||yes||yes||yes|
|Read only viewers see site staff information||no||no||n/a|
|Country profile enhancements|
|Display country status labels||yes||yes||yes|
|Country status modified via API||yes||yes||n/a|
|Edit country status permission||yes||yes||n/a|
|IP release enhancements|
|Add country-level IP release package||yes configuration designer||yes||yes|
|Include site-level documents in country-level IP review planning||yes||yes||yes|
|Country-level Review activities tab||yes||yes||yes|
|Country-level approval icon||no||no||n/a|
|Other Activate enhancements|
|goBalto Help Center permission||yes||yes||n/a|
|Document via study library tooltip||no||no||n/a|
|Annotation icon and count||no||no||n/a|
|Note type for site experience users||yes||yes||yes|
|Contract activities "C" icon||no||no||n/a|
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