This brief provides early insights into the upcoming 18.4 release of Oracle’s goBalto Activate. All features are subject to change upon release.
For tips on rolling out these features to your organization, see the implementation planning checklist, and contact your Oracle goBalto project manager for more information.
We’ve included the following sections in this brief:
- API integration
- CRO/sponsor collaboration
- Data standardization
- IP release review
- Study library
- Study metadata
- Submission and milestone planned dates
- Other enhancements
- Technical information
- Implementation planning checklist
We’ll introduce the following API integration enhancements with the 18.4 release:
- API documentation will be updated as follows:
- All APIs that allow a JSON schema will be defined using JSON instead of RAML
- All APIs that provide a response will have a response schema definition
- Event APIs will have a valid schema definition
- Activate will optionally prevent study sites from being created via POST API if the country for that site does not yet exist in the study.
- Artifact Publish will be updated to generate a single publish message when certain metadata fields on an artifact change.
- Artifact Publish and Artifact GET methods will include new CTMS fields.
- To help users differentiate between items, the placeholder header in Activate will display the internal “Item ID.” This ID can also be used to look up outbound messages in the Event message page.
Activate will introduce an account-level overview page that will allow users to easily view, filter, sort, and search for their work and activities across all studies/accounts to which they have access. Account details with activity and milestone counts and icons will display above the overview page in the sticky header. We’ll also add activities to the previously-available account cards.
An oversight “Level” filter will allow CROs and sponsors to subset activities based on country, site, principal investigator, sub-investigator, or other staff types (e.g., pharmacist, lab director, etc.).
Global artifact and milestone descriptions will display when users hover over the item in the overview page and in other areas of Activate.
To ensure that users access actionable activities, sites or countries that are in the system statuses Dropped, On Hold, or Closed will not have any activities display in the overview page, and counts of activities will not be impacted by these sites or countries.
Therapeutic area and phase name fields in study create/edit workflows will include the default labels. For example defaults will include Dermatology, Hematology, Oncology, and many other therapeutic areas as well as I, II, III, etc. for phase name. These will be required fields. Labels displayed to users can be adjusted to your preferred label; please contact your Oracle goBalto project team to discuss adjustments.
IP release review
Significant enhancements to the IP Release feature will increase usability and address eTMF publishing requirements.
Workflow enhancements include:
- Updates to the document approval step will allow users to specify “First review” or “Final approval”
- If enabled for the account, IP approval will prevent approval unless all documents within the package have been approved.
- Updates to the define package step will prevent users from defining a package that has no documents selected
- Updates to the Review tab, which will display the activity name above the Done button. If the activity has configured decision options, the name will display above the options; if no options are configured, the Activity name will display above the Notes field.
- Updates to document versioning for package documents will allow for adding to or replacing items in packages that have been defined, but not completed.
- Updates to document review will display the expiration date under the item name as well as new clock icons to indicate if an item is approaching or past expiration date.
- If enabled for the account, the following fields will also be available on define and review screens:
- Local approval
- Submission to FDA
Note enhancements include:
- Updates to the define step will allow users viewing activity for a rejected document to enter a note for that document. The user will also have the ability to view previous, timestamped notes, as well as note author and category. The user can then choose a note category and add a response note for the previous note.
- Updates to the review tab to include a note icon next to the document name if a document has one or more notes. When clicked, a pop-in will display all activity and item notes, note author(s), note timestamps, and whether the note is in response to the item or activity.
- Updates to the IP review tab to display individual notes for each document (separate from review notes). A note icon will display with each document when the individual document has one or more notes.
- Updated IP Package ZIP format export, which will automatically update without user intervention when the package’s Define step is completed and when the two new note items (described above) are created.
If enabled for the account, when the package is completed, Activate will create a PDF format document containing all of the notes on the individual documents within the IP review process, as well as all the notes on the package itself.
Within IP review, the PDF file will be included in the “Documents included in this review” section. The PDF will be part of the document export if the export is updated after completion of the package. The document will also be published to the eTMF system.
We'll enhance Study Library to make it easier to keep a standard configuration and then customize it to the needs of the study. For example, having just one ICF or patient material item and then being able to delineate between them using a new Type field to specify what sort of ICF or patient material. Users will have the ability to specify a “Type” for each document. When adding a document, users will be able to add a new type or select from a Type list that contains all Types previously created for that study.
If enabled for the account, a new “Responsible party” field will allow Study Library users to specify the individual or organization responsible for creating the study document that will be distributed to countries or sites. This field will be a configurable drop-down list that optionally includes “Other” (25 character max).
We’ll add the ability for permissioned users to remove documents that have not yet been shared from the Study Library. The previously available “Enable upload to study library” business role permission will be updated to “Enable upload and removal of documents from Study Library.” All users with this business role permission will have the ability to remove unshared documents.
The Shared Documents confirmation pop-in will include a new tooltip that clarifies the countries and sites to which the item will be shared.
Document preview will display additional metadata fields for responsible party, document group, document date, and description if this data exists for the document.
Share button logic will be updated so that the button is only enabled when there are new items to share. (e.g. If an item is only configured to share down to a country it will not be re-enabled when a new site is added to that country).
We’ll make several updates to fields on the submission define and review screens. With release 18.4, up to 5 “Additional” fields will be available. Fields 1, 2, 4, and 5 can optionally be configured with a predefined drop-down list of values, including “Other.” Field 3 will stay a free-text field that does not support a configurable list. Data previously entered into Additional fields 1 and 2 will be been migrated to “Other.”
With release 18.4, we’ll make multiple submissions enhancements to add new functionality and simplify workflows:
- Users who have a new “Enable managing agency upload” business role permission will be able to upload a CSV format file containing the different submission agencies the CRO/Sponsor may work with across countries. When uploaded, the agencies will be available for users to select in a new, “IRB/EC/RA” type-ahead selection field in country and site level submissions.
- If enabled for the account, submission Type, Category and/or IRB/EC/RA fields can be configured as required. When configured, the user must enter a value for the field(s) before completing the final activity of the submission.
- When planning a submission package, users will have the ability to order the files included in the package export ZIP file. In the package placeholder, a new “Define order for this package” hyperlink will display a pop-in where the user can manually number the order of the files.
- To ensure package ZIP export files have the most recent content, we’ll add two new automatic triggers for export updates. With these new triggers, a new export file will be created (1) each time a package is re-defined and (2) each time a package is ordered via the “Define order for this package” link (described above).
Submission and milestone planned dates
Submissions and milestones will be updated to require users to select a “Reason for change” value from a drop-down list (rather than entering free text) when updating planned dates. Reasons included in the dropdown list are configurable, and “Other” is also available. This update will affect all submission, package, and milestone areas in Activate where it is possible for the user to update the planned date.
Additional enhancements are part of this release and some of these items include:
- Activate will introduce a new business role permission for participatory users, “Enable edit planned number of sites.”
- A new business role permission, “Enable study participants to manage sites and staff” will allow participatory users to add or edit a site/principal investigator and/or staff, delete a site, and/ or replace a principal investigator and/or staff.
- With release 18.4, accounts enabled for contract types can also be enabled to require that users specify the contract type before completing the final contract activity.
The list of supported browsers has not changed with this release. For details, see the Browser support article.
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?|
|Display internal Item ID||no||no||n/a|
|therapeutic area and phase name fields||yes||no||n/a|
|IP release review|
|Document "First review" or "Final approval"||no||no||n/a|
|Prevent package approval||no||yes||no|
|Prevent defining package with no selected documents||no||no||n/a|
|Review tab displays activity name||no||no||n/a|
|Display document expiration||no||no||n/a|
|Local approval, Approver, Submission to FDA fields||yes||yes||yes|
|Notes on rejected document||no||no||n/a|
|Display note icons on Review tab||no||no||n/a|
|Display note icons on IP Review tab||no||no||n/a|
|Create PDF of all notes||no||yes||no|
|Publish PDF to eTMF system||yes||yes||n/a|
|Specify document Type||no||no||n/a|
|Responsible party field||yes||yes||yes|
|Shared document tooltip||no||no||n/a|
|Preview additional metadata||no||no||n/a|
|Enable managing agency upload (permission)||no||yes
|Require type, category, and/or IRB/EC/RA||no||yes||yes|
|Submission package file ordering||no||no||n/a|
|ZIP export update triggers||no||no||n/a|
|Submission and milestone planned dates|
|Reason for change drop-down list values||yes||yes||yes|
|Enable edit planned number of sites (permission)||no||yes
|Enable study participants to manage sites and staff (permission)||no||yes
|Require contract type||no||yes||yes|
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