These release notes describe enhancements, stability improvements, and known issues in the 19.2 release of Oracle Health Sciences Select. We've included the following sections:
- New in This Release
- Stability Improvements
- Hotfix 22.214.171.124 available for this release 16AUG2019
- Known Issues
- Severity Definitions
- Browser Support
- Help Center Transition Announcement
- Open Source Attribution
- Article Revision History
New in This Release
Study level permission
Using a new team management feature, Select users can now be permissioned by study. This feature introduces a new permission, "Team management," and study administrators with this permission can use the new teams feature to limit the users who have visibility into a study within an account. Team managers have the ability to create, edit, and define a team using a new "teams" option under the "setup" menu.
Through an interface similar to Role creation, study administrators will specify a unique team name and choose permission(s) for the team members. In addition, the team defines one or more studies within the account that the team members can access. Administrators can optionally create a team description of up to 100 characters.
When the team has been successfully created, administrators can then assign the team to one or more individual users. Note that:
- a user with any role level permission in the account has access to all studies
- a user with a team permission, but no role permission, has access to only those permissions assigned to their teams
- a user with a role permission and a team permission has all study access, but limited to the union of their permissions
Administrators should be aware that restrictive permissions do not necessarily override inclusive permissions. For example: If a user is granted the "Review and Approve Assigned CDA/Document Submissions Only" permission in a team for a specific study, but provided the "Review and Approve All CDA/Document Submissions" permission via a role, then the All CDAs permission will take precedence. Exceptions to this will be called out by feature.
To restrict users' access by studies:
- Create a a team
- Assign the necessary permissions to the team
- Assign the studies to the team
- Assign users/team members to Teams
To provide ALL studies access to a user, create a role in the Roles tab and assign users to the roles. There is no need to use the Teams feature.
Site level permission
We enhanced Select to include a new feature by which users can be restricted for assignment to a subset of sites within an account. This enhancement introduces a new permission, "View/manage assigned sites only." Users with this permission will be restricted to a subset of sites within their permissioned studies. To be listed as a user available to assign to a site, users must also be:
- granted at least the site nomination permission
- permissioned to the study
- a valid user within the account
Users granted permission to all studies and who have at least the site nomination permission will be available for site assignment. Additionally, a user with "View/manage assigned sites only" permission is allowed to see all sites within a study they are assigned to as a union of their other study-related permissions. Meaning, a user who has been granted only the "View/manage assigned sites only" permission will not see any sites in the site grid because that user lacks other study permissions such as study nomination/shortlist permission.
To restrict users access by sites:
- Create a team
- Assign the necessary permissions to the team
- Assign the studies to the team
- Assign users/team members to Team
- Assign team members to sites
The combination of an individual user's permissions, role, and team assignment affect the sites visible in the sites grid as well as the actions a user can take. Here are some examples of expected behavior:
- A user with the "View/manage assigned sites only" permission will see no sites in Step 1 of Select for all studies if assigned in a role
- If a user is granted the "View/manage assigned sites only permission" at the team level, the user will see no sites in Step 1 for the studies defined in that team
- If the grid is empty for either reason above, Select displays the following message: "No sites are available based on your current level of study and/or site permissions."
- A user granted the "Site nomination" permission at the role level, but assigned the "View/manage assigned sites only" permission at the team level will have the sites in the team-assigned studies limited to only those in which they are assigned
- A user with the "Site nomination" permission and the "View/manage assigned sites only" at the role level will only see sites for which they are assigned for each study
Also note, bucket state counters will reflect the sites visible to the user. For example: A user is permissioned to only 10 of 15 sites in the shortlist. The counter on the bucket state link for Shortlist will read Shortlist (10).
An individual user's permissions also affect the content of CSV and PDF downloads. For users granted the "View/manage assigned sites only" permission, these are additional examples of expected behavior for downloads:
- All CSV downloads from Step 1 will be empty since site assignment occurs on Step 2. There is no way to assign a site located in Step 1.
- CSV downloads from any bucket state in Steps 2-4 will be limited to only those sites for which the user is assigned, and if no sites are assigned to a user in any bucket state of Step 2, then all downloaded CSVs will be empty
- If a user is revoked access/assignment to a site, Select will not retroactively reflect this change; however, future downloads of a CSV site grid will reflect the change in site permission
- A user cannot download the PDF of a site's survey results for whom the user is not permissioned to view/manage
- The download option for Site profile updates CSV includes only those sites to which the user is assigned
Revoking access and permissions
Please note: When revoking a user's access to a study, first remove the user's site assignments from within the study's site grid.
If a user becomes ineligible to be assigned to a site for a study, the site(s) are currently not reverted to the unassigned state. For example, a user is permissioned to a study and assigned to a subset of sites within that study. The user is later removed from the study or the user has site nomination permission removed from his or her account. Upon revocation of the study or permission, all sites assigned to that user are not automatically reverted to the unassigned state. Existing site assignment behavior related to receiving email notifications and having the site-assigned user's email address be the reply-to email address is unchanged. To prevent users from receiving email alerts that are not actionable, if removing a user's site assignment, either unassign the user from the site or assign access to a different user.
Users/managers can run the Site progress report in Analyze and filter on "Assigned User" to see which sites need to be reassigned before revoking a user's access to studies.
Note: Users assigned to fewer than all sites in a study are revoked from accessing Analyze reports for that study.
Analyze report permission
Release 19.2 introduces a new "Analyze access" permission. The new permission provides a user with access to Select reports in Analyze based on his or her account and study permissions. With this enhancement, only permissioned users will view the "Analyze reports" link in the dashboards menu. Users who have the "View dashboards" permission, but do not also have the new Analyze access permission can view the dashboard menu as they did previously, but the Analyze reports link will not be available.
The Analyze access permission also automatically provisions and permissions the user's Tableau account in Analyze if he or she did not have an account before receiving the new Analyze access permission. Users are permissioned in Analyze to the account reports for their account(s). This means:
- A user with Analyze permission can only view reports only from his or her Select account
- If the user is assigned to specific studies, the user can see only the reports data for assigned studies
Select users now have the ability to recall a CDA document that was sent to a site within the CDA workflow. Permissions on which CDA documents, if any, a user can recall follow their CDA-assigned permission(s); no additional permission is required to recall a CDA. For example, a user with the "Negotiate CDAs I'm assigned to only" permission can recall only those CDAs that are in scope of this permission.
Site users who have authenticated into Select LITE via a username/password maintain their ability to delete their last uploaded CDA by navigating to the Document library tab in Select LITE.
When viewing the Document approvals area on either the Requires resubmission or Approved tab, users who manage CDAs will now see a "Recall" action button in the Document History modal. The Recall button is available only for the most recent document.
When a user clicks Recall, a confirmation modal displays that identifies the outcome of the Recall action (e.g., "The document workflow will be reverted to Pending review"). If appropriate for the document, additional warning text display may display. For example, "You are about to recall the document submitted to the site for review. This will remove the document from the site's document library and active document task. It will also revert the document workflow back to Requires approval. If the site has already downloaded the document, this feature will not remove that download from their system."
If the user chooses to recall the document by clicking the Recall action button:
- The document link is removed from the Select LITE document library and the Select LITE action task bar
- The CDA workflow is reverted back to the Select user (e.g., the document submission is "undone")
- Comments associated with the document are removed
- No email notification is sent to the Select user or site users
If a Select user takes the action of requesting a resubmission from a site, but does not upload a document, and the Select user wishes to recall that "submission" the recall action will revert the action of requesting a resubmission, but will have no impact on a document submission.
- There is no document link to remove from the Select LITE document library nor the Select LITE action task bar
- The CDA workflow is reverted back to the Select user
- The audit log is updated to reflect the recall
- No email notification is sent to any Select or Select LITE user
- The comments associated with the submission are removed
Note: For CDA document actions performed prior to CDA recall enhancement being implemented, the recall function may not be available to remove a file that was added by a Select user. The action itself can be reverted, but the document will persist in the CDA history. This does not impact CDA document actions performed after this release.
Targeted Investigator Search
Select users who have a new "Perform a targeted data source search" permission can now search for investigators who are not included in a study's data sources and add an investigator from the results list directly to the Nominate bucket state. We added a new page for this feature under the "manage" menu, called "data source query." To perform the search, users must identify the data source for the search as well as the investigator's country. Data sources are limited to those attached to the study. To refine the search, users can include additional criteria, such as Investigator first name, last name, city, and specialization(s).
Search results include a three step process to ensure the user is adding the correct investigator to the study. The steps are:
- Investigator results - select an investigator from the results list
- Institutions - choose the investigator's affiliated institution
- Actions - if both the investigator name and the institution are as expected, add the investigator to the Nominated list. Note: users will not be able to nominate a site if the site is already found in the study.
Data Source Enhancements
With release 19.2, we added multiple new data columns and filters as follows:
|investigator Indication Tiers||No||Tier data from public data sources for an investigator's experience with indications/disease areas|
|Investigator's Geo Location||No||The investigator's location reported as latitude and longitude|
|Investigator Supporting URLs||No||The references cited for investigator data|
|PI Contributing Data Sources||Yes||The data sources contributing to this investigator record|
|PI Drug Experience||No||The number of studies, for an investigator, conducted for each experienced trial drug|
|PI Indication Experience||No||The number of studies, for an investigator, conducted for each experienced indication|
|PI Last Trial Start Date||Yes||The start date for the last trial the PI participated in|
|PI Latest Reg Action - Action||Yes||The PI's latest regulatory action|
|PI Latest Reg Action - Date||Yes||The date of the PI's latest regulatory action|
|PI Latest Reg Action - Details||No||The details of the PI's latest regulatory action|
|PI Latest Reg Action - Flag||Yes||A flag that marks the PI's latest regulatory action|
|PI Ongoing Trials||No||List of trials associated with the investigator that are reported as currently ongoing|
|PI Past Trials||No||The reported history of trials associated with the investigator|
|PI Reg Action Attest Date||Yes||The date an investigator attests to be free of any sanctions or regulatory actions against them|
|PI Reg Action History||No||Structured regulatory actions data from public data sources|
|PI Trial Phase Experience||No||The number of studies, for an investigator, conducted for each experienced trial phase|
|Sponsor Relationships||Yes||The relationship between the PI and the Sponsor|
|Institution||Yes||The strategic collaborators associated with this institution|
|Institution Contributing Data Sources||Yes||The data sources contributing to this institution record|
|Institution Last Trial Start Date||Yes||The date of the last trial started at this institution|
|Institution Total Ongoing Trials||Yes||Total number of trials associated to the organization, with a trial status of open, closed, planned or temporarily closed|
|Institution Total Past Trials||Yes||Total number of trials associated to the organization, with a trial status of completed and terminated|
|Institution Total Trials||Yes||Total number of trials associated to the organization|
|Trial (available for composite data sources only)|
|Actual Enrollment Duration||Yes||Actual enrollment period in months|
|Actual Enrollment Period Close Date||Yes||Actual enrollment end date|
|Actual Primary Completion Date||Yes||Actual treatment period in months|
|Actual Total Trial Close Date||Yes||Actual Date that the treatment achieved the Primary Endpoints Objectives, or the actual Treatment period end date of the study|
|Actual Trial Start Date||Yes||Anticipated trial start date|
|Anticipated Enrollment Duration||Yes||Anticipated enrollment period in months|
|Anticipated Enrollment Period Close Date||Yes||Anticipated enrollment end date|
|Anticipated Primary Completion Date||Yes||Anticipated treatment period in months|
|Anticipated Total Trial Close Date||Yes||Actual Date that the treatment achieved the Primary Endpoints Objectives, or the actual Treatment period end date of the study|
|CTMS Notes||No||Extra information/notes reported for a trial from a CTMS record|
|CTMS Trial Notes||Yes||Structured notes for a trial|
|Predicted Max Peak Enrollment Duration||Yes||Estimated longest (max) enrollment period in months. Calculated using Trialpredict|
|Predicted Max Peak Enrollment Period Close Date||Yes||Estimated latest (max) enrollment end date. Calculated using Trialpredict|
|Predicted Max Peak Treatment Period End Date||Yes||Estimated longest (max) treatment period in months. Calculated using Trialpredict|
|Predicted Min Peak Enrollment Duration||Yes||Estimated shortest (min) enrollment period in months. Calculated using Trialpredict|
|Predicted Min Peak Enrollment Period Close Date||Yes||Estimated earliest (min) enrollment end date. Calculated using Trialpredict|
|Predicted Min Peak Treatment Period End Date||Yes||Estimated shortest (min) treatment period in months. Calculated using Trialpredict|
|Trial Actual Accrual||Yes||The number of patients who entered the trial; only includes final information|
|Trial Actual Accrual Text||No||The number of patients expected to enter the trial, includes interim information|
|Trial Countries||Yes||The country a trial was reported to run|
|Trial CROs||Yes||Full service CRO(s) identified in public domain as supporting trial|
|Trial Data Sources||Yes||The data sources contributing to this trial record|
|Trial Disease||No||The diseases associated with a trial|
|Trial Exclusion Criteria||No||Criteria for excluding a patient from a trial|
|Trial ICD10||No||The ICD10 codes associated with a trial|
|Trial ICD9||No||The ICD9 codes associated with a trial|
|Trial Identified Sites||Yes||Total number of sites, as confirmed by our SiteTrove analysts|
|Trial Inclusion Criteria||No||Criteria patients must meet to be included in a trial|
|Trial Investigators||No||Unique Investigator assigned by Citeline associated to the trials|
|Trial Keywords||No||Key study design attributes (i.e. cross over, randomized, etc.)|
|Trial MESH Terms||No||The MESH terms associated with a trial|
|Trial Notes||No||Extra information/notes reported for a trial|
|Trial Other Drugs Tested||No||Secondary/Tertiary Drugs used to investigate an indication in a trial|
|Trial Other End Point||No||Information about secondary/tertiary objectives, endpoints or outcomes|
|Trial Outcome Details||No||Further information supporting trial outcome|
|Trial Outcomes||Yes||Outcome of completed or terminated trial|
|Trial patient criteria||No||The age range, age units and gender of patients|
|Trial Patients Per Site Per Month||Yes||Predicted patients/site/month calculated by public data provider|
|Trial Primary Drugs Tested||No||Main drugs(s) used to investigate an indication in a trial|
|Trial Primary End Point||No||Information about primary objectives, endpoints or outcomes|
|Trial Primary Endpoints Reported||Yes||Information about primary objectives, endpoints or outcomes|
|Trial Regions||Yes||The regions in which a trial has run|
|Trial Reported Sites||Yes||Total number of sites, as referenced in trial publications or registries|
|Trial Results||No||Where and when trial results were presented or discussed|
|Trial SNOMED||No||The SNOMED codes associated with a trial record|
|Trial Study Design||No||Investigative methods used in the clinical study|
|Trial Supporting URLs||No||URL for supporting source information related to trial|
|Trial Target Accrual||Yes||The number of patients expected to enter the trial|
|Trial Target Accrual Text||No||The number of patients expected to enter the trial, includes interim information|
|Trial Treatment Plan||No||Treatments given in the study, including arms and treatment details|
|Trial Site (available for composite data sources only)|
|CTMS Study Site Unique ID||No||The CTMS unique identifier for a study site|
|First Patient In Date||Yes||The date the first patient was enrolled in the trial at this site|
|Last Patient In Date||Yes||The date the last patient was enrolled in the trial at this site|
|Number of Subjects Completed||Yes||The number of subjects completed at this site for this trial|
|Number of Subjects Enrolled||Yes||The number of subjects enrolled at this site for this trial|
|Number of Subjects Failed||Yes||The number of subjects failed at this site for this trial|
|Number of Subjects Randomized||Yes||The number of subjects randomized at this site for this trial|
|Number of Subjects Screened||Yes||The number of subjects screened at this site for this trial|
|Site Active Date||Yes||The date this site was activated for this trial|
|Trial Site Data Sources||Yes||The data sources contributing to this trial record|
|Site Contributing Data Sources||Yes||The data sources contributing to this site record|
|Site Drug Experience||No||The number of studies, for a site, conducted for each experienced drug tested|
|Site Indication Experience||No||The number of studies, for a site, conducted for each experienced indication/disease area|
|Site Trial Phase Experience||No||The number of studies, for a site, conducted for each experienced trial phase|
We also relabeled the following standard data columns:
- Strategic collaboration - PI has been relabeled to Strategic collaboration - Investigator
- Contact concerns has been relabeled to Investigator concerns
- Contact concerns comments has been relabeled to Investigator concerns comments
Site Grid and CSV Column Enhancement
Select users can now choose "Site notes" column to display in the site grid and/or include site notes in a CSV export. Site notes is included in the "Site progress" filter when selecting columns for the grid or CSV. When selected, all site notes will be outputted, including all notes that display in the site grid note modal.
For both CSV and the site grid, site notes display in a single column, in the following format: bucket - bucket state; date time; note author first name and last name initial; note text. For example: Evaluate - Short list; 21May2019 12:45 PM; Karen W; The site has been shortlisted. For the site grid display of notes, if there are multiple notes in the single column, they will be separated by a single blank line.
Users can also now choose to display "CDA status" in the site grid and/or include CDA status as a column in a CDA. CDA status is included in the "Site progress, Workflow tasks" filter when selecting columns for the grid or CSV. The three CDA statuses are: 1. Not started 2. Pending 3. completed.
Feasibility Survey Enhancements
To make it easier to identify blank survey responses, we updated the survey PDF export to specify (No response) when a site does not response to a text-response question type.
Email Template Enhancements
Forward email copy
Email template managers can now enable a feature that will forward a copy of all site emails to an account manager or other specific email address. We added a new check box control, "Send a copy of all site communications to" to the default template, and this control is also available on each country-level tab and can be overridden from the default level. The user can enter one email address in the field provided with the new control; multiple addresses are not supported. If a customer requires email copies sent to multiple addresses, a distribution list address should be entered in the field.
The duplicated email will include an identifier that prepends the email subject line of the originating email. Note that site users will not see this prepended identifier, nor will site users have any indication that a copy of the email is sent to another email address. The prepended identifier includes the following information: "Archived <study_id>; <PI_lastname>, <PI_firstname>: <original subject line>".
Additionally, Select LITE links in the following email types are disabled in the copy sent to the specified address:
- Resent invitation
- CDA notification
Disable No login links
Organizations that prefer to have some or all site users log in to Select LITE to complete tasks can now enable and disable the "No login" links in site emails. Email template managers will find the new option in the template Default tab, as well as on the individual tab for each country included in the study. We've included helper text that displays when the option is enabled. The text is, "By turning off the 'No login' link option for site invitation emails, sites will be required to login to Select Lite to complete site tasks. Any 'No login' link a site received prior to toggling this option off will be invalidated." The copy of a site's study invitation email (Welcome email) will have the No Login links disabled.
Previously, trial data displayed in the site grid was not updated from trial disambiguation after updating a protocol number. With this release, we updated disambiguation logic as follows to ensure updated data displays as expected in the site grid:
- Trial records now display a concatenated list of protocol numbers for all trial records matched to them.
- If a trial record in a higher priority data source has a null trial entity field and is matched to a trial record in a lower priority data source with a value for the same trial entity field, then the lower record's value displays for all trial site records associated with the trial in the higher priority data source.
Resend invitations to individual users
We enhanced the Site Progress tab Invitation Received status table to now display when users click the green check-mark icon rather than hover over the icon. We also updated this enhanced modal to display the list of each site user with a valid email address. A new "Resend invite" column includes "resend" links for each listed user. When clicked for an individual site user, Select will send an email invitation to that specific site user for the particular study.
The CSV export erroneously included the Trial Coordinator email address when this column was not selected for inclusion in a short list sub-tab export.
Previously, Select displayed the most recent 50 data sources when a user was importing site lists. We modified this display, and now all data sources display in the Account data source management page.
Surveys did not display in Select, and the survey status continued to show as "In Progress" although the surveys had been successfully completed.
When attempting to add a site note from the note icon in the site grid and when saving a note for site non-inclusion, the notes did not save and users experienced an error.
|Permissions and Roles||
After changing a user's role, the list of users did not display until the user refreshed the page.
The survey "Edit" link was not visible to site users when the workflow step name had 30+ characters and was automatically truncated.
|Site decline /disinterest||
Site disinterest reasons did not wrap text as expected in site progress modal.
On step 3 (select), invited list, Site details sub-tab, when a user attempted to "Add user to study sites," the resulting list was a subset of eligible users rather than the full list.
Previously, if a site had completed the "Enter estimated patient count" task, the patient count did not display in the site profile under the "Patient Availability" heading as expected. This issue has been resolved. To make this information more prominent in the profile, we moved Patient Availability display to the upper right of the Scorecard tab. The "Estimated patient count" now displays as the count entered or as "n/a" if not entered.
Hotfix 126.96.36.199 available for this release 16AUG2019
Fixed in 188.8.131.52
|Select LITE||Sites were unable to view the task details in Select LITE.||
New Known Issues
Users experience an error and are unable to download default or workflow specific protocol documents from the manage protocol documents page.
On step 3 (select), when users sort the site grid by CDA Status column and there are multiple pages of sites in the grid, the number of sites displayed per page is inconsistent.
In Internet Explorer 11, pressing backspace in the workflow task name field will direct user to the previous page.
Previously Reported Issues
When using the Chrome browser on Windows only, dragging fields in the data source mapping tool makes them difficult to see until dropped onto another field.
When using the IE11 browser, on the Manage Workflow page, users cannot select text or position the cursor anywhere in a text field using the mouse.
Workaround: To select text, use Ctrl-A or tab into the field from another field.
If a Select LITE user copies and pastes the “No login” link from an invitation email into a Chrome browser incognito window, the user is then unable to upload a signed CDA from Select LITE.
When using the Chrome browser and viewing the Short list site grid, the grid does not remain aligned when scrolling.
When a registered Select LITE user is locked out of his/her account, Select displays a notice of lockout status on the login page, but no email is sent to the user who invited the site informing the individual that the Select LITE user account is locked.
When users download a CSV from the Investigator or Sites tab on the Nominate step, dropped list, the CSV displays a “Declined by” column instead of “Dropped by” column.
When users download a CSV from the Evaluate step, on hold list, the CSV displays a “Held by” column instead of “On hold” column.
Intermittently, the “Participating?” and “4th invitation sent” columns do not display on the email invitations page.
The account data administrator is prevented from removing a public data source, but the remove button does not currently reflect a disabled state when choosing a public data source.
Select does not block account deletion when an account has existing private data sources, which can result in orphaned data sources after account deletion.
Users receive an error when attempting to delete an unpublished data source, and the unpublished data source then changes to published after the error.
When using the arrow buttons to rank data sources by priority, when clicked once, the up arrow button moves the last listed data source to the top of the list rather than one level higher in ranking.
After resolving a record match on the Resolve data source matches page, the PI email field continues to display instead of dropping out of view as designed.
Authenticated Select LITE users will see an Attach button in the Document Library that only partially displays, but is still functional.
After approving a document on the Document approvals page, Requires approval tab, a success message should display.
If a CDA or generic document has not been downloaded or submitted for a study, the target graphs on the Document approvals page do not display.
Workflow and task names are not displayed on the Document approvals page as expected when viewing a country-level generic document.
When attempting to reauthorize the Select account with SurveyMonkey, users are rerouted to Select instead of SurveyMonkey and account edits are not saved.
The words “feasibility survey” are not displayed in the tooltip for incomplete workflows.
For Survey Monkey star rating type questions, Select incorrectly parses incoming data.
Please refrain from using this question type until this issue is resolved.
Drugs tested filter is not reflected as an available filter option.
Trial FPI filter is not reflected as an available filter option.
It is not possible to directly delete text values in any fields on the Manage Milestones page.
Workaround: To change a text value, select the value in the field and overwrite it with a new value.
Country level milestones do not automatically populate when adding dates to the study.
When viewing the Master List, if the Select user clicks the Notes button, “Enter a new note” text does not display within the notes field, as designed.
|Select/ Activate integration||
When the maximum number of sites (400) are migrated in bulk to a new or existing study in Activate, the status icons for each site do not reflect a successful migration until the page is refreshed.
In Internet Explorer 11, when a user updates site details and clicks Done, the user is not redirected to the Home page, as expected.
When a site selects the Download link for a CDA, the Actions menu is not available as expected and the hover-over tooltip directs the site to download the document.
Sortable columns on the site communications table do not include a column header icon indicating they are sortable.
|Site decline / disinterest||
Drag and drop ordering functionality for site decline and disinterest reasons does not properly reflect the "drop" position.
|Site decline / disinterest||
When users add a new reason for site decline or site disinterest, the "+Add new reason" and "Done" action buttons are disabled.
On step 3 (select), Site Progress sub-tab, the site grid column heading for "Workflow close date" does not display as expected.
When a site is assigned a workflow that includes the Verify site interest or Verify site interest again task, and the site indicates “No” for the task, the previous task is displayed as the last completed task in the site grid, rather than the Verify site interest/Verify site interest again task.
Users are not prevented from reversing site finalization when the site has already been migrated to Oracle Health Sciences Activate.
|Survey response CSV / PDF||
In the survey response PDF, if the site’s selected answer falls just before a page break, the check mark indicating the selected answer displays at the top of the next page.
Visiting the Manage milestone page before Workflow configuration has been set will display a blank milestones page. Clicking Done on this page will remove the task from the list even though milestones have not been set.
When users manually reduce browser window size, horizontal scroll bars do not expand the full width of the window to allow access to all content on the page.
When creating or editing a site workflow configuration, task order numbers do not properly align if the workflow includes a Generic document task.
On the CDA approvals page, the CDA box border lines appear/disappear when a user changes the browser zoom level.
When selecting columns under the “Site” section, the focus is on the bottom of the expanded view instead of the top as designed.
Site grid columns become misaligned when users scroll up and down.
In Internet Explorer 11, the header on the Assign document reviewer modal is misaligned if the user scrolls down.
On the Manage study details page, the Country, Specializations, and Therapeutic Areas drop-down selection boxes remain open when the user navigates away to a different element on the page.
On the Document approvals page, circles in the progress graphic do not display full circles as designed.
Missing tasks (e.g., Upload protocol and Manage email templates) do not block users from inviting sites as expected.
The issue(s) below is/are no longer applicable to Oracle Health Sciences Select (e.g., does not occur, will not be prioritized for fix, working as designed, and/or does not affect current functionality). We removed the item(s) from the known issues (Previously Reported Issues) list.
|Site decline / disinterest||
When users attempt to reorder the list of disinterest reasons by dragging and dropping, the reasons do not pin to the intended order and instead return to the original order.
The legend for tasks in the site progress tab shouldn't be displayed on the survey analysis tab as they are not relevant.
When completing a task on behalf of a site, the horizontal scroll bar covers the task information.
Note: The severity definitions below conform to the Oracle support severity options users now select when creating support tickets. The descriptions below replace the previous "Priority Definitions" (low, normal, high, and urgent). With Release 19.2, we updated the Stability Improvement and Known Issue tables above to reflect numeric severity levels. With release 19.3, we will eliminate reference to low, normal, high, and urgent priorities in release notes.
Your production use of the supported programs is stopped or so severely impacted that you cannot reasonably continue work. You experience a complete loss of service. The operation is mission critical to the business and the situation is an emergency.
You experience a severe loss of service. Important features are unavailable with no acceptable workaround; however, operations can continue in a restricted fashion.
You experience a minor loss of service. The impact is an inconvenience, which may require a workaround to restore functionality.
You request information, an enhancement, or documentation clarification regarding your software but there is no impact on the operation of the software. You experience no loss of service. The result does not impede the operation of a system.
The list of supported browsers has not changed with the 19.2 release. For details, see the Browser Support article.
Help Center Transition Announcement
goBalto Help Center content will transition to Oracle Help Center in August 2019. With this transition, product documentation (release notes, how-to articles and more) will be available in both goBalto Help Center and Oracle Help Center for releases 19.1+.
To aid in the transition process, we will provide an extended period of overlap for the two solutions. goBalto Help Center will be decommissioned in December 2019.
Oracle Help Center provides simple access with no account setup or login required. Some of the features are:
- Content is searchable
- Documentation can be viewed in HTML (online) or download to PDF
- Product Change Logs will provide cumulative release history
- Easy access to documentation for all other HSGBU cloud applications
Please contact your Oracle application lead for additional information.
Open Source Attribution
Oracle Health Sciences Select uses certain third party open source software. For details, see the Open Source Attribution article.
Article Revision History
ADDED release notes for Hotfix 184.108.40.206 (available for this release 16AUG2019)
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