18.4 Oracle goBalto Activate release notes

These release notes describe enhancements, fixes, and known issues in the 18.4 release of Oracle's goBalto Activate. We've included the following sections:

• new in this release
• known issues
  • fixed issues
  • new issues
  • previously reported issues
• priority definitions
• technical information
  • browser support announcement
  • open source attribution
• article revision history

new in this release

description
API integration	With release 18.4, we made the following updates to our Activate API documentation: All APIs that allow a JSON schema are now defined using JSON instead of RAML All APIs that provide a response now have a response schema definition Event API documentation now provides a valid schema definition We also made the following API integration enhancements with this release: Activate can now prevent study sites from being created via POST API if the country for that site does not yet exist in the study. We added an optional field to Study Site API POST where customers can indicate if they want a site created without country or not. The new field is: country_should_already_exist (Boolean). If True, the study site will not be created if country does not already exist prior to study site POST and an error message will be returned: "Country does not already exist." If the field is not passed, it will be interpreted as False. We updated Artifact Publish to generate a single publish message when metadata fields on an item change. The single publish message will be triggered when a user: Clicks Save on the corrections tab for an item if any of the fields listed below are updated Clicks Save on the Information section of a document, submission, package, contract, or IP package if any of the fields listed below are updated Clicks Save at the top of a budget or contract item if any of the fields listed below are updated Completes choosing documents for a submission package or updating the documents that are in a submission package The metadata fields are: version_label (string) status (string) tmf_artifact_id (integer) meeting_date (date) expiry_date (date) description (string) submission_type_id (integer) submission_category_id (integer) submission_reason (text) contract_document_type (string) on_holded_at (datetime) terminated_at (datetime) agency_name (string) organization_name (string) language_id (integer) per_subject_cost (decimal) per_subject_cost_deviation_percentage (decimal) total_cost_of_one_time_up_front_fees (decimal) total_one_time_up_front_fee_breakdown (string) institutional_overhead (decimal) currency_id (integer) wet_ink_location (string) effective_date (date) bilingual (Boolean) template_original (string) contracting_party (string) payer (string) allocated_patients (integer) has_msa (Boolean) ignore_expiry_date (Boolean) ignore_meeting_date (Boolean) adjustment_reason (string) item_description (text) tmf_identifier_v2 (string) responsible_party (string) We updated Artifact Publish and Artifact GET methods to include new CTMS fields. The new fields are:' Artifact Publish irb_ec_ra_name (string) created_date (e.g. "2016-07-18T01:38:56+05:30") created_by (string, email of user, system_user if created by automatic triggers) updated_by (string, system_user for artifact creation messages, email of user who completed or updated the artifact) no_effective_date (Boolean, true if checkbox checked, otherwise, false) no_meeting_date (Boolean, true if checkbox checked, otherwise, false) discontinued_reason (string, available only if trigger is discontinuing the artifact) reinstatement_reason (string, available only if trigger is reinstating the artifact) Artifact GET irb_ec_ra_name (string) To help users differentiate between items, Activate now displays the internal “Item ID” within a submission, package, document, budget, IP define and review, etc. widget’s information section. This ID can be used to look up outbound messages on the Event message page.
audit trail reports	To simplify access to Audit trail reporting, users who have privileges to generate Audit trail reports will now access this feature directly from the Reports menu drop-down using a new "Audit report" option. Functionality for the Audit trail reports was not changed with this enhancement. Audit report option in Reports drop-down
contracts	Accounts enabled for contract types can now also be enabled to require that users specify the contract type before completing the final contract activity. With this new option enabled, the Type dropdown field has an asterisk to indicate that it is required, and a new Contract type indicator displays just above the Complete Activity button. Both items have a gray checkmark icon until an input occurs and a green checkmark icon after an input has occurred. Users will not be able to enter a Completed date and click Complete Activity until both items have the green checkmark. Required "Type" field and Contract Type required item
CRO/Sponsor collaboration	Activate introduces an account-level overview page that allows 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 display above the overview page in the sticky header. We also added activities to the previously-available account cards. Overview page An oversight “Level” filter allows CROs/sponsors to easily subset activities based on country, site, principal investigator, sub-investigator, or other staff types (e.g., pharmacist, lab director, etc.). Level filter If configured, item and milestone descriptions display on the overview page and in other areas of Activate. Finally, 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.
data standardization	Therapeutic area and phase name fields in study create/edit workflows now include the default labels below. These are required fields. Displayed labels can be adjusted to your preferred label. Please contact your Oracle goBalto project team to discuss adjustments. Therapeutic area defaults Cardiology/Vascular Disease CNS Dental and Oral Health Dermatology Endocrinology Family Medicine Gastroenterology Genetic Disease Healthy Volunteers Hematology Hepatology Immunology Infections & Infectious Disease Musculoskeletal Nephrology Neurology Nutrition & Weight Loss Obstetrics/Gynecology Oncology Ophthalmology Otolaryngology Pain Pediatrics/Neonatology Pharmacology/Toxicology Plastic Surgery Podiatry Psychiatry/Psychology Pulmonary/Respiratory Rheumatology Sleep Trauma (Urgent Care) Urology Vaccines Other (50 character maximum) Phase defaults I II III IV Other (50 character maximum)
IP release review	We made significant enhancements to the IP Release feature to increase usability and address eTMF publishing requirements. Usability enhancements Approval step We updated the document approval step. Now, when users select “Approve” in the Complete document review step, they can choose “First review” or “Final approval.” First/Final approval options Package approval If enabled for the account, Activate prevents package approval unless all documents within the package have been approved and completed. When this feature is enabled for the account, all documents in the package must be approved before the final activity (the activity that completes the IP item) can be completed. We updated the user interface to help guide users when documents and activities are outstanding or incomplete. On the final activity, the following must be complete (green checkmark icon) before the “Done” button is enabled: Documents reviewed Package reviewed Decision option (Approved, Send for 2nd review, Reject) Completed date Define package step We updated the define package step to prevent users from defining a package that has no documents selected. Activate now disables the “Done” button until at least one document is selected for the package. Review tab To clarify which activity is being completed, the Review tab now displays the activity name above the Done button. If the activity has configured decision options, the name displays above the options; if no options are configured, the Activity name displays above the Notes field. Document versioning and replacement We enhanced the process for creating a new version of a document that is included in one or more packages. This enhancement allows for adding to or replacing the earlier version of the document in packages that have been defined, but not completed. Only users who have a new “Enable package update” permission may replace documents. Other users who are assigned to at least one activity on that item (or if the item itself is assigned to “Anyone”) may add documents but not replace documents. When the user clicks “Add a new document version” he or she will select one of the following options before clicking Confirm: add this document to the package and leave old document as well add this document to the package and replace the old document do not add this document to the package and leave old document Add new/replace document version action options If the IP package is in First QC passed or Approved state, the second option above (...replace the old document) is not displayed. When a document has been replaced, this action is reflected in the Define and Review steps. To the right of the document name, users will see (replaced), and the new document displays just above the replaced document. Review step showing (replaced) document If the user replaces a document within a submission package, it updates the documents in the package under related documents section; view package document status; and if the ZIP file is refreshed, the document download ZIP. Document expiration date display To raise awareness of document expiration at the country level, when viewing documents on the Review screen, the expiration date now displays under the item name. We’ve also added red and orange clock icons to indicate if an item is approaching or past expiration date. A gray clock icon indicates the item is a new document version. Document expiration icons Review tab sorting On the Review tab, users can now sort the Documents, Status, and Review columns. New fields If enabled for the account, the following fields will also display on define and review screens: Local approval (yes/no radio buttons; defaulted to no) Approver (free text, displayed only if Local approval is changed to yes, 50 character limit) Submission to FDA (yes/no checkboxes, unselected by default) Notes enhancements Rejected document notes On the define step, users viewing activity for a rejected document can now enter a note for that rejected document. A note icon next to the document opens a pop-in where the user can view previous, timestamped notes, as well as note author and category. The user can then choose a note category and add a response note. Document note icons On the review tab, if a document has one or more associated notes, a note icon now displays next to the name of the document. When clicked, a pop-in displays all activity and item notes, note author(s), note timestamps, and whether the note is in response to the item or activity. Individual document notes The IP review tab now displays individual notes for each document (separate from review notes). The note icon displays with each document only when the individual document has one or more notes. Note icons ZIP export The IP Package ZIP format export now automatically updates without user intervention when the package’s Define step is completed and when the two new note items (described above) are created. eTMF enhancements Saving notes for the entire IP package review process may be required by some customer eTMF systems. If enabled for the account, when the package is completed, Activate will now 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 displays under the section, “Documents included in this review” with the file name and document title “IP Review Notes - [Package Name + Principal Investigator]. 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.
study library	We enhanced 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. Documenttype Study Library users can now specify a “Type” for each document (100 character max). When adding a document, users can add a new type or select from a Type list that contains all Types previously created for that study. Add or select type when adding document On the Document tab, users can add, edit, or remove types and filter the document list using the Type filter. The Share tab also allows users to filter documents by type. Type displays as a second line below the document name on both the Document and Share tabs. Documents tab - Add, edit, remove type When a document has a type associated, the type displays throughout the Activate application anywhere that document is available (e.g., Workflow Wizard, document placeholders at site and country levels, Corrections area, etc.). Important note: To ensure data quality and avoid confusion, on the Document Activities tab for both country and site, we updated the placeholder’s “Document information” section by relabeling the previous “Type” label to “Category.” Document placeholder Category label (replaced "Type") Responsible party If enabled for the account, a new “Responsible party” field in Study Library allows users to specify the individual or organization responsible for creating the study document(s) that will be distributed to countries or sites. The Responsible party field is a configurable drop-down list that optionally includes “Other” (25 character max). The dropdown field displays when Study Library users click the pencil icon in a document’s Actions menu on the Documents tab. On the Share tab, the selected Responsible party value displays when Study Library users click the item’s Action icon. Responsible party field Remove documents We’ve added the ability for permissioned users to remove documents that have not yet been shared. To support this functionality, we updated the previously available “Enable upload to study library” business role permission 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. On the Documents tab, the “Remove document” option is available in the Actions dropdown; this option is visible only to permissioned users. When selected, if the document has not yet been shared, a success message displays. If the document has already been shared, alert text displays instead to inform the user that the document will not be removed. Remove document in Actions options Document preview We enhanced Study Library document preview to display additional metadata fields. When data exists for the fields below, preview will include these fields in the right-side pane: Responsible party (if enabled for the account) Document group Document date Description Share button Share button logic has been updated so that the button is only enabled when there are new items to share. For example, if an item is configured to share down only to a country the Share button will not be re-enabled when a new site is added to that country.
study metadata	We made updates to fields on the IP release define and review screens. Now, up to 5 “Additional” fields are available. Fields 1, 2, 4, and 5 can optionally be configured with a predefined drop-down list of values (50 character limit per item, “Other” supported). Field 3 remains a free-text field that does not support a configurable list. Data previously entered into Additional fields 1 and 2 has been migrated to “Other.”
submissions	With release 18.4, we made multiple submissions enhancements to add new functionality and simplify workflows: Submission agencies Activate customers now have the option to upload a CSV format file containing the different submission agencies they may work with across countries. When uploaded, the agencies will be available for users to select in a new, “IRB/EC/RA” typeahead selection field in country and site level submissions. Users must have a new business role permission, “Enable managing agency upload” to upload the CSV agency file. When users have this permission, the top navigation’s “More” menu includes a new “Manage submission agencies” option. Access submission agencies CSV upload option The CSV file must include three columns in the following order: agency_id - (25 character maximum) display_name (255 character maximum) active (true/false) Note that agency_id is a unique ID for each submission. If the ID already exists in Activate, the existing record will be updated (i.e., update either/both display_name and active). If the ID does not already exist, Activate creates a new agency record. Submissions versioning We updated submissions versioning logic that previously tied a submission to type and category. Now, a new revision of a submission will be created if a new submission item is created via the workflow wizard for the same submission item on the same protocol version - even if type or category is different. If a new submission is created for the same submission item via the workflow wizard, on a new protocol version, then Activate will not create a new revision. Require Type, Category, and/or IRB/EC/RA 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. Users in accounts with the required field(s) will see a “Required” section above the Done button on submissions. The field name(s) will have a gray checkmark icon until an input occurs and a green checkmark icon once an input has occurred. Users will not be able to enter an Actual date and click Done until all items configured as required have a green checkmark icon. New "Required" section displays above Done button Submission package ordering When planning a submission package, users can now order the files included in the package export ZIP file. In the package placeholder, a new “Define order for this package” hyperlink displays a pop-in where the user can manually number the order of the files. Each number can be used once, and when an item has no number, it will be ordered in the ZIP file alphabetically on item name and then by item number. The file will be ordered by manually numbered items first, followed by alphabetized items (e.g. 123ABC). Submission package file ordering Automatic export update triggers To ensure package ZIP export files have the most recent content, we added two new automatic triggers for export updates. A new export file will be created: Each time a package is re-defined Each time a package is ordered via the “Define order for this package” link (described above)
submission and milestone planned dates	We updated submissions and milestones to now require users to select a “Reason for change” value from a drop-down list in all areas where users can update planned dates in submissions, packages, and milestones. Reasons included in the dropdown list are configurable, and “Other” (100 character maximum) is also available. Please contact your Oracle goBalto project or account manager to discuss configuration details. Reason for change
other enhancements	Enable edit planned number of sites business role permission Activate users who have participatory access can now be granted a new business role permission, “Enable edit planned number of sites.” This new permission does not affect administrative access users, who will continue be able to edit the planned number of sites without this permission. Enable study participants to manage sites and staff business role permission A new business role permission, “Enable study participants to manage sites and staff” allows participatory users who have a role with this permission to: Add or edit a site/principal investigator and/or staff Delete a site Replace a principal investigator and/or staff. Upon upgrade to 18.4 Activate, all existing business roles will automatically be granted the new permission. If preferred, your Oracle goBalto project manager can disable the permission for one or more roles. When creating a new role after upgrade to 18.4, the permission will be disabled by default and can be enabled as preferred for the role. Please note: If the account creates sites only via API integration (site creation disabled in the Activate user interface), users with the new permission will not have the ability to add a site from within Activate Users must also have the “Enable change Principal Investigator” business role permission in order to replace a Principal Investigator Users must also have the “Enable site status change” permission to edit the site’s status

known issues

fixed issues

description		ticket	priority
Activate LITE	The sort control on the Age column did not sort the column as designed.	CHK-20302	normal
API integration	A triggered collections issue occurred when a site was loaded via API without IRB/EC/RA type. Now, the Actions menu “Replace PI” option and “Replace PI” button on the PI edit form is available only if “Enable multiple principal investigators” is enabled for the account and IRB/EC/RA type is present.	CHK-20363	normal
	eTMF messages were not published as expected after a file was attached and review/approve activities were completed.	CHK-20553	normal
	Edits to the IRB/EC/RA field did not create messages with publish data as expected.	CHK-21662	normal
audit trail report	The audit trail report calendar date picker was updated to not allow a user to select a future date because audit items will always be a report of past activities.	CHK-20224	low
	After generating an Audit trail report, previously selected dates were not automatically cleared, and users were unable to select dates outside of the date range for new report.	CHK-20283	normal
	When generating an Audit trail report, the quick selection buttons for “Past month,” “Past 6 months,” etc. did not automatically populate date fields as designed.	CHK-20390	normal
bulk work	When editing selected countries in Bulk Work, the select all checkbox displayed as unchecked when all countries were selected.	CHK-15448	normal
	When a long country name was truncated in the bulk work filter, the number of country instances did not display to the right of the country name as designed.	CHK-15953	normal
	When a user uploaded a document, the current document date (or manually specified date) successfully saved to the attachment, as expected. However, if the next activity was completed using the bulk work tool, the document's date was erroneously updated to the current date.	CHK-21183	high
	The wet ink control (yes/no) always displayed in bulk updating of documents even if the account did not have wet ink enabled.	CHK-20320	high
contracts	When a contract was fully executed, the “Add Budget” button in the Contract widget was still available. Now, when a contract reaches fully executed status, the “Add Budget” button no longer displays, and users can add an additional budget via amendment, if necessary.	CHK-17148	normal
	Per subject cost field allowed non-numeric characters.	CHK-20258	low
	To avoid confusion, the contract amendment pop-in has been updated to reference “Method” instead of “Type” for the amendment (i.e., one-way, two-way), and the Method drop-down now  displays only if there are multiple methods configured for the account.	CHK-20934	normal
	Contract amendment reason was no longer displayed in the widget header after making changes (e.g., adding type or adding version ID).	CHK-20935	normal
country milestone dashboard	Scroll arrows were displayed in the country milestone dashboard pop-in when there were not multiple milestones to view.	CHK-20279	normal
document management	If an item was discontinued without any activities being completed, the Approve activity marked for auto-completion was also completed and erroneously changed the status of the item from not started to in progress.	CHK-20632	normal
	When migrating files to BOX storage, some files for studies that included forward slash, space, and/or underscore in the study name were not successfully migrated	CHK-21046	urgent
electronic signature	When previewing an attached document’s information, a blank gray space displayed next to eSignature.	CHK-19423	normal
	An error message pop-in related to electronic signature configuration was partially obscured.	CHK-20216	normal
	Users were unable to start the electronic signature request on a second uploaded document after electronic signature was completed for another uploaded document within the same item widget.	CHK-20244	normal
	Users assigned to study were not available to be tagged to electronically sign a country level document.	CHK-20303	high
	When an item had a pending electronic signature request and all activities for the item were subsequently completed, the electronic signature "waiting" icon no longer displayed in the File history section.	CHK-20315	high
infrastructure	We updated our licensing with underlying third party components to align with our latest subscriptions. There is no functional impact to any application processes, features, or functionality.	CHK-20296 CHK-20297 CHK-20298 CHK-20299 CHK-20300 CHK-20301 CHK-20489 CHK-20490	normal
IP release	IP release package, submissions, and submission packages did not display with the Principal Investigator name after the Principal Investigator was replaced.	CHK-18431	normal
	Notes were not automatically created as expected each time an IP package was completed.	CHK-21035	normal
	When an IP package item was completed, the date of input was used as the date the IP review was completed to determine which items were post-IP. Now the date selected from the calendar widget will be used.	CHK-21248	high
	Double clicking on a review item in the Actions menu created duplicate packages.	CHK-21734	normal
notes	We removed functionality that allowed visibility of notes at the site level for a country level item. This functionality has been replaced by the “Share note with site” feature.	CHK-20637	high
single sign on (SSO)	Users who access Activate via single sign on (SSO) who timed out of the system were intermittently sent to the wrong logout URL, which resulted in an error message for the users.	CHK-20772	high
site experience	Site experience users were unable to view attachments for country level items after the item was completed and an attachment was added.	CHK-20420	normal
site management	Users with participatory access were unable to add or edit a site and users with view-only access were unable to view an inactive Principal Investigator on the staff tab.	CHK-20894	high
study library	While editing group name of 100+ characters, the name extended outside of the edit group pop-in.	CHK-16600	low
	Documents that were already shared with a country could not be added or removed in bulk to a document group.	CHK-16606	normal
	When using the overall checkbox in the Documents tab of the “View study library documents” section and then toggling to the Share tab, the checkbox remained populated. Unchecking it then showed negative documents to share (i.e. -1).	CHK-19133	normal
	After adding more than 30 documents to study library, users needed to refresh the page for the next/prev navigation menu items to display.	CHK-19811	low
submissions	Numeric package identifiers did not increment correctly (e.g., P1, P2, P3, etc.).	CHK-15465	normal
	In submission planning, the PI column displayed the artifact owner not the Principal Investigator, as expected.	CHK-18932	normal
user interface	Activate does not allow users to update Principal Investigator information if IRB/EC type is not specified, and error text for this issue displayed above the visible window.	CHK-20397	normal
	The pop-up asking users to enter a reason when taking certain actions (e.g., discontinuing contract) had inaccurate header text.	CHK-20630	high
workflow wizard	Clicking multiple times on the confirmation button at the end of the workflow wizard created duplicate items.	CHK-20415	normal

new issues

description		ticket	priority
API integration	The milestones PUT command functions even if the mandatory field "Reason" is not passed.	CHK-20101	normal
	When identifying a site, principal_investigator PUT calls do not validate the uniqueness of cros_pi_id and sponsors_pi_id fields, and do not return an error if the call specifies a pre-existing value for either field	CHK-20128	normal
bulk work	Contract amendment Reason field in bulk work is a free text field rather than a drop-down list of preconfigured values, as designed.	CHK-21829	normal
contracts	If contract activities are blocked by budget and contract language activities, and the activities are completed, the “view blocking items” link displays until the page is refreshed.	CHK-18192	normal
	Creating a new budget version on a contract item successfully adds a new version, but the new version does not include a revision number as expected.	CHK-20631	normal
	Contract type is an editable field under budget or contract language when it should not be editable.	CHK-21871	normal
	Budget and submission items do not display descriptions when configured to do so.	CHK-21876	normal
CRO/sponsor oversight	By design, all countries and sites are not selected in the Overview page filter, so the number of Activities in the sticky header does not match the total in the “Your alerts” filter.	CHK-21812	normal
	When a user has access to a study in a partner account and the study status is updated to “In closedown,” the user no longer has access to the study.	CHK-21888	high
electronic signature	When using the Internet Explorer 11 browser, if a user double clicks the “Include electronic signature request" toggle, an invalid file type (e.g., CSV) can be accepted into the tagging process, but the document fails on creation.	CHK-21870	normal
IP release review	After rejecting a review package and completing the activities, if the user double clicks the Done button, two identical notes are created.	CHK-21747	normal
	When users enter over 50 characters into an Additional field’s “Other” option, no error displays.	CHK-21794	low
	On country-level IP release packages that have document notes, It is not possible to complete the package without approving the notes.	CHK-21895	normal
site experience	If a site user replies to an alert email and does not include an attachment, and an Activate user accepts the item within the quarantine area, no activities are completed and the status icon erroneously shows an in progress icon.	CHK-11105	normal
study library	If “Type” value for an item in the document grid is 100+ characters, the “Displaying” counter at the upper right of the grid is displaced.	CHK-21797	low
	Type value is not displayed as expected for lineage documents in Define IP Release Package and Corrections, Activities.	CHK-21813	normal
	Long names of 100+ characters are cut off in the header of the Edit/Remove pop-ins for Group and Type.	CHK-21852	low
	In the individual share modal, the checkbox to select an individual country should be disabled if there are no sites for the country.	CHK-21875	normal
	The Groups filter does not display as expected for users who do not have permission to add, edit, and remove groups.	CHK-21878	normal
submissions	When submissions are at the individual site level, the “Sites approved from this submission” checkbox should not display.	CHK-21715	normal
team member assignments	Partner names display three times in the Seed Users drop-down list. Selecting any of the three listings does not impact seeding, all execute appropriately against the user list.	CHK-20815	normal
user interface	Under "File History" on an item (i.e., documents, submissions, packages, contracts), the “Previous files” toggle displays even when there are no previous files.	CHK-21705	low
workflow wizard	Custom site status labels do not display as expected in workflow wizard.	CHK-21064	normal

previously reported issues

description		ticket	priority
Activate LITE	If files are present in Activate LITE and/or the quarantined files page, they are not removed when the study country is deleted.	CHK-1413	normal
activities	The paperclip icon indicating an attachment does not display in a package header. Workaround: refresh the page	CHK-16128	low
ad-hoc documents	When you select one or more sites from the ad-hoc document site selection list, you can’t see site number or status, which are needed to help determine which sites should get the document.	CHK-2668	low
alerts	Alerts sort order does not change when ‘display in processing order’ checkbox is unchecked.	CHK-8520	normal
APIs	When the site status changes, that change is not published in the API.	CHK-7378	normal
audit trail report	If you have access to the audit trail and review updates to Add and Edit study pages, the "Additional" fields don’t appear in the audit trail.	CHK-1416	normal
bulk work	Activate users can set expiration dates for blocked items in Bulk Work but not in item placeholders.	CHK-18929	normal
contracts	The budget create/edit page shows all collections beyond contract collections.	TOGO-2902	normal
	When a completed date for an activity is deleted, it cannot be reset. Workaround: refresh the page.	TOGO-2899	normal
	When adding a contract through the Workflow wizard, Budget and Contract Language are erroneously listed twice.	CHK-16658	normal
	When editing a completed budget to replace the currency value, the new value does not display after clicking Done in the edit modal. Workaround: refresh the page	CHK-20273	low
CRO/Sponsor collaboration	The business partner or site assignments icon has inconsistent display logic for submission packages.	CHK-20086	normal
document management	When file upload fails due to configuration or a detected virus, the file upload process fails, but the document status is still updated.	CHK-2898	normal
documents	No alert message is generated when a duplicate Country ad hoc protocol-related document is created.	CHK-8844	normal
electronic signature	If a user is tagged to electronically sign a contract type document, but the user is not assigned to a business role with access to contracts, the user can’t open the alert in Activate to complete the electronic signature process. Workaround: User can access the contract document via a link in the email notification.	CHK-20210	normal
	When a tagger sends a document to multiple signers, but uploads a new document before the signers have provided the electronic signature, Adobe Sign does not send email notification to the recipients that the first document has been cancelled.	CHK-20291	normal
global search	When performing a search with results for a PI or Sub-I that is inactive or replaced, the search does not indicate that they are replaced.	CHK-10502	normal
	Global search does not return results when a search keyword has a dash (for example: “Study-1068”).	CHK-10472	normal
milestones	The icon that indicates that a milestone is at risk does not display.	CHK-7855	normal
	When you use the corrections tool on the home page to update baseline or actual milestone dates, the name of the person who made the change and the time changes were made don’t display on the Timeline change history report.	CHK-1231	normal
	Changes to planned dates on country and site details pages don’t update until you refresh the page.	CHK-1403	low
	On critical path reports, items are listed as milestones, even though they’re not milestones.	CHK-982	normal
other	Users whose accounts are provisioned using SSO, aren’t designated as such on the user management page.	CHK-1770	normal
search documents	The default text for the search documents filter (individual and bulk views) should be “filter by file,” “document,” and “protocol version.”	CHK-1367	normal
site experience	When a site user discontinues a submission, the submission erroneously disappears from Site experience.	CHK-16576	normal
	When a site experience user clicks on an alert, the corresponding widget does not automatically expand as expected.	CHK-20280	low
staff documents	If a staff document is assigned a display order number, and then that staff member is deactivated, the document will continue to display in the original order, instead of at the end of the list.	CHK-10104	low
study library	When study library document versions are created in quick succession, documents may cross over into different versions of country level placeholders in lineage.	CHK-5985	normal
	In a newly created study site or study country, multiple lineage documents are created from the new version of an already shared study document.	CHK-8606	normal
submissions	Submission packages don’t display staff names next to staff-level documents; only the PI name displays.	CHK-971	normal
	If a reason is provided, user can only see 1000 of the potentially 3000 characters of the reason. Workaround: See the full description in the submission information section of the submissions widget.	CHK-3230	normal
	When adding a new package to a submission, additional sites selected in planning do not have the initial submit dates from the first package or any Final Approval baseline and planned dates that have been specified.	CHK-16825	normal
team member assignments	Study level assignments only show when you select “For my role” on the home page.	CHK-7925	high
	Users who do not have study or department administrator system roles can access the Team member and roles assignment page.	CHK-4325	normal
	A user without permission to manage sensitive users can make one sensitive user the “primary assignment” in the study, country, or site assignment modal.	CHK-10136	low
	On the team member assignment page Site and Study Country tabs, no confirmation message displays when you assign a business role to multiple persons.	CHK-2235, CHK-2231	low
user interface	The site status pie chart does not accurately reflect site status if the country status has been changed to “on hold.”	CHK-20162	low

Priority definitions

priority	description
1 urgent (blocker)	Catastrophic interruptions that result in service unavailability (outage). Issues may include application unavailable errors, or critical data or services being offline, for which there are no identified workarounds.
2 high (critical)	Major application issues that interrupt normal and expected behavior of one or more modules or business critical features of the application, but have manual or process-driven workaround.
3 normal (important)	Does not prevent operation of the application. Issues could include incorrect behavior of the application or performance issues.
4 low (minor)	Occurs in the field with no impact to production systems. These are generally questions relating to availability of training or help content.

technical information

browser support announcement

Our goal is to provide our customers with the best experience and advanced product capabilities, while maintaining maximum security. As we enhance Oracle goBalto products, older browsers may no longer provide the capabilities required to support these objectives.

On a regular basis, we assess browser usage and support policies by Microsoft, Google, etc. and adjust our browser support policy accordingly. Based on our most recent analysis, Microsoft Internet Explorer 9 and Internet Explorer 10 site users comprise less than 0.25% of all unique users.

As of the 19.1 release, we will no longer support Internet Explorer 9 and Internet Explorer 10 for Oracle goBalto Activate Site Experience and Oracle goBalto Activate LITE. Note that Microsoft ended support for these browsers in 2016.

Our browser assessment also indicates growing use of Microsoft Edge and Mozilla Firefox browsers for site users. As of the 19.1 release, we will add Microsoft Edge and Firefox as supported browsers for Oracle goBalto Activate Site Experience and Oracle goBalto Activate LITE.

Note: The list of supported browsers for Activate has not changed with the 18.4 release. For details, see the Browser support article.

open source attribution

Oracle's goBalto Activate uses certain third party open source software. For details, see the Open source attribution article.

article revision history

date	description
04APR2019	NO CHANGES - Opened article to public viewing
28FEB2019	ADDED additional field-level details to the single artifact publish message enhancement in the API integration section.
14FEB2019	ADDED Audit trail report enhancement to New in this release section. This enhancement was omitted from release note publication in error.
25JAN2019	REMOVED configuration designer item CHK-22317, "The budged create/edit page shows all collections beyond contract collections." from the Activate Previous Reported Issues list. This item is now tracked in the Previous Reported Issues list in the Activate Configuration Designer release notes.
20JAN2019	REMOVED global search item CHK-10543 from Previous Known Issues list. This item was fixed in release 18.3 and was included in the 18.4 release notes in error.

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