This feature brief describes what's coming in the 18.3 release of goBalto Activate. We've included the following sections:
- API integration
- account-level milestone overview
- audit trail report
- country milestone dashboard
- CRO/Sponsor collaboration
- electronic signature
- study library
- team member assignments
- other 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 18.3 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’ll introduce the following API integration enhancements with the 18.3 release:
- Updates to the the IRB API to allow for country document updates
- Updates to the Artifact GET API to return meeting date and adjustment reason if these fields are on a submission.
- Updates to the Study Country API POST, GET, and PUT methods to support enabling/disabling electronic signature* functionality.
- Updates to the Study API POST, GET, and PUT methods to support enabling/disabling electronic signature* functionality.
- A new Study PUT API allows for updating studies and enabling/disabling electronic signature* at the study level.
*We’ve described the new Activate electronic signature functionality below.
account-level milestone overview
Activate will introduce a new account-level milestone overview. When enabled for the account, users will see a new “four-square” overview icon in the persistent header just to the left of the account name. When clicked, a new panel will display below the header that includes an account overview card.
The account card is an at-a-glance view of studies to which the user has access and raises visibility of that individual user’s actionable items. The card will provide a searchable study list (including total study count) as well as country and site milestone counts. Studies that have past due, due soon, or unplanned milestones will have numerated status icons within the searchable study list.
audit trail report
We’ll enhance audit trail reporting with release 18.3. When Activate standard reports are enabled for the account, users who have “Access to audit report” enabled in their individual user account settings will access the self-service audit trail report from the Reports menu.
Enhanced audit trail reporting will allow users to initiate a report for a specific study and time range. Activate will generate audit trail reports asynchronously, and users can initiate the report request and navigate away from the reports area while the report generates. When the report is complete, a report link will display in the Audit trail reports area in a new “Previously generated report” section. Users will be able to download the completed file multiple times, if necessary, and the report link will remain available.
We’ll enhance corrections functionality to allow users to correct metadata contained in a document, contract, budget, or contract language item. This enhancement will introduce a new business role permission, “Enable data change users with this role to correct metadata.” Users who have the new permission and a “data change” flag on their individual user accounts will be able to edit metadata fields that have been enabled for the account and/or configured for an item. For example, users can edit document date, wet ink, item language, payers, contracting party, and many other metadata fields.
We’ll also update document corrections capabilities to prevent corrections users from modifying documents, attachments, and IP review packages once an item transmits to an eTMF system. Users in accounts that have been enabled for eTMF transmission will see alert text indicating why they are unable to edit.
country milestone dashboard
Activate will introduce a new country milestone dashboard that will allow users to better understand the current status of a study at a glance and quickly pinpoint areas where they are falling behind. Using a new “Display settings” control, users will have the option to make the country milestone dashboard or the previously-available document dashboard their default view for all studies. Regardless of the default view setting, users will have the option to easily toggle between milestone and document views.
The milestone dashboard displays milestones and submissions made visible on the country timeline and is highly interactive. Users will be able to quickly add, remove, and optionally save filters for countries and milestones; enable/disable display of milestone statuses; select dates or a date range for the timeline; and toggle from month to week view. Hover-over tooltips will also provide a status summary for each milestone (country, status, milestone name, dates, and access to replanning notes when available).
With this release, we’ll significantly enhance Activate CRO/Sponsor collaboration functionality.
- Customers that have partner relationships will have access to a new account-level view where users can see progress across all studies/accounts to which they have access, as well as milestone views of all studies. This new view will follow the same design pattern described in the account-level milestone enhancement above.
- A new information icon will display at the study, country, and site levels in the persistent header. The icon displays when the study being viewed has been shared with a sponsor partner for oversight. When users hover over the icon, tooltip text will display the sponsor name.
- To ensure that the appropriate data is shared between CROs and sponsors, we’ll add a new section to the add/edit study page where administrative users can select the types of messages to be published outbound to the sponsor as well as the endpoint URL.
- When at least one activity in an item is assigned to a business partner or a site, new icons will display within the item at the country or site level, at the “Open Activities” heading. Hover-over tooltip text will identify the site or business partner name, assignee name, activity required, and the date assigned.
- Because items and milestones could have unique use cases between accounts, we’ll add hover-over tooltip text to help users understand what an item and/or milestone actually represents. The tooltip will include a brief description for the item or milestone.
Note: The CRO/Sponsor collaboration functionality described above must be enabled for the Activate account, and each partner’s account(s) must be upgraded to at least Activate 18.3. Partnership must be approved and enabled between the two accounts to enable any of the above capabilities.
To speed the study startup process and reduce the amount of time required to gather signatures for contracts and essential site documents, Activate will introduce integration with electronic signature vendor, Adobe Sign.
When enabled for an account, the electronic signature feature will allow users to sign important documents, in an FDA-compliant manner, within Activate and via mobile device. Electronically signed documents can also be transmitted into eTMF systems if this integration is enabled for the account since the signature is digital.
Please note that electronic signature capabilities will incur pass-through subscription fees. Contact your goBalto Project Manager for more information.
We’ll enhance study library functionality to present users with additional information about shareable countries and sites and improve the sharing workflow. We’ll add new text to help communicate why some countries that received the document may be displayed in the shareable view (e.g., “Documents were shared with this country and new sites have been added since”). We’ll also add a new step in the Share tab that allows users to review and confirm the list of countries being shared to before sharing.
team member assignments
Customers will no longer need goBalto assistance to create and manage individual user accounts. Activate users who have a new business role permission, “Enable manage user accounts,” will now be able to create and edit individual user accounts and manage individual user account settings within the team member assignments area.
The following enhancements are also part of the 18.3 Activate release:
- If the currency field for contract metadata is enabled for the account, users entering data into the Contract widget currency field will be able to use a new type-ahead search to find the currency, if necessary.
- We’ll update activity age displayed in Activate LITE to accurately reflect "0" days when a successor activity becomes unblocked.
- We’ll update submission and package logic to allow users to enter an actual date for a package or submission activity that is earlier than a completed date of a document listed as a predecessor on a define package activity. Activate will continue to prevent users from entering earlier dates for dependencies within the package and submission item (this logic was introduced in release 18.1).
- On the add/edit site page, we’ll relabel the “IRB name” field to “IRB/EC Name.” We’ll also add a new “Clear” option to the IRB/EC Name and Network field dropdowns. If users mistakenly add an IRB name or Network to a site that they did not mean to add, they can easily clear the entry and replace the incorrect entry or leave the field blank.
- We’ll make a minor modification to the label of the add/edit site page’s PI section toggle. Previously, the toggle was labeled "PI/Staff," and we’ll update the label to "PI."
- If enabled for your account, when users upload a file, they’ll have the ability to select a future Document Date using the calendar date picker.
- Users will have the ability preview a file under the lineage section of country and site level items.
- To assist Activate users with troubleshooting SSO failures, we’ll add an error page that uses a secure process to define the parameters that were passed in to Activate in the SSO request (e.g., first name, last name, email, etc.) and the parameters Activate requires to successfully complete the SSO request.
- Previously, if a package was discontinued that had the initial submit date milestone tied to it, it was not possible to tie the date of a new package to the initial milestone. We’re enhancing submissions logic to detect and correct this issue. Every 24 hours, Activate will automatically review the account. When Activate finds a submit date activity that has not been completed on a discontinued package, and a non-discontinued package exists, Activate will tie the submission to the submit activity on the latest non-discontinued package.
- To prevent redundant alert emails, Activate will no longer send two alert emails to users who have both “All alerts” and “New alerts” set as their email preference if the alert emails would have transmitted within the same hour.
- Bulk work users will have the ability to enter a document date and specify a wet ink setting (yes or no) when adding an attachment on the Activities tab.
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?|
|account-level milestone overview||no||yes||yes|
|audit trail report||no||yes||yes|
|Access to audit report (individual user account setting)||yes||yes||yes|
|Enable data change users with this role to change item metadata (business role permission)||yes||yes||yes|
|country milestone dashboard||no||no||n/a|
|Administrative user selects message types and partner endpoints||yes
add/edit study page
|Configuration designer users add item descriptions||yes
|Administrative user enables/disables electronic signature functionality at the country and/or study levels||yes
add/edit study page and/or add/edit country page
|Enable management of electronic documents (business role permission for document tagging)||yes||yes||yes|
|Enable signing of electronic documents (business role permission for document signing)||yes||yes||yes|
|team member assignments||no||no||n/a|
|Enable manage user accounts (business role permission)||yes||yes||yes|
|Contract metadata currency field search||yes||yes||yes|
|Activity age displayed in Activate LITE||no||no||n/a|
|Enter earlier actual date for package or submission activity||no||no||n/a|
|Add/edit site page, updates to IRB name field, and new “clear” option||no||no||n/a|
|Add/edit site page, relabeled PI section||no||no||n/a|
|Select future Document Date||yes||yes||yes|
|goBalto corrections to document dates||no||no||n/a|
|File preview under lineage section of an item||no||no||n/a|
|SSO error troubleshooting page||no||no||n/a|
|Detect and correct orphaned packages||no||no||n/a|
|“New alerts” not sent if triggered in the same hour as an “All alert”||no||no||n/a|
|Enter document date and/or wet ink setting in bulk work||no||no||n/a|
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