18.2 Select release notes

These release notes describe enhancements, bug fixes, and known issues in the 18.2 release of goBalto Select. We've included the following sections:

• new in this release
• bugs fixed in this release
• hotfix 18.2.0.5 available for this release 11AUG2018
  • bugs fixed in 18.2.0.5
• hotfix 18.2.0.4 available for this release 08AUG2018
  • bugs fixed in 18.2.0.4
• hotfix 18.2.0.3 available for this release 31JUL2018
  • bugs fixed in 18.2.0.3
• hotfix 18.2.0.2 available for this release 18JUL2018
  • bugs fixed in 18.2.0.2
• hotfix 18.2.0.1 available for this release 02JUL2018
  • bugs fixed in 18.2.0.1
• known issues
  • new items
  • previously reported items
• priority definitions
• technical information
  • browser support
  • open source attribution
• article revision history

new in this release

description
composite trial-site data model	Select’s underlying data structure now has the ability to handle all five composite data entities that comprise a trial-site (sometimes referred to as study-site): Investigator Institution Trial site trial-site Each composite data entity also supports nested data structures such as structured data. This enhancement not only allows users to leverage our existing site workflow, but adds study-site metrics to the site nomination workflow. For example: Select can now import unique institution records that will combine with investigator records to form sites. Instead of having limited fields to import institution staff records, the investigator file can now handle any number of institution staff in a nested structure of: first name, last name, email, phone, and role. Instead of being limited to an investigator’s primary and secondary email, the investigator file is now able to import any number of investigator email addresses. Select also introduces new study detail filters with the 18.2 release. When creating a master list of sites for evaluation, if the data source contains composite records, users can additionally filter by: therapeutic area, indication, drug class, and/or study phase. These filters are dynamically generated based on the available values in the data source. If no data is available for a filter, that filter does not display.
studies tab	Select introduces a new Studies tab that improves display of composite study site data. For each item below, import of composite study site data is required. The Studies tab provides: a toggle control that allows users to view the master list as sites or study sites a site grid capable of displaying multi-cardinal/structured data filters based on study site data that affect only the nomination step’s study site view
SurveyGizmo Integration	Select now integrates with SurveyGizmo as an additional survey provider option. SurveyGizmo provides advanced functionality including the ability to show/hide questions, close individual surveys, create question/survey templates, apply RegEx validation to question responses, apply advanced theming and label/text formatting, SSO, and white label the survey domain to any private domain. When using SurveyGizmo, an invited site receives a unique URL, which allows the site to save progress. goBalto is an authorized reseller for SurveyGizmo, and accounts will be provisioned by goBalto. Please contact your goBalto Project or Account Manager for details.
survey scoring	Select release 18.2 includes multiple enhancements to survey scoring functionality: Survey scoring now calculates at the question and category levels as well as the total survey score. There is no longer a limit on the number of categories (previously labeled “Key criteria”), and each question is now required to have a category assigned to it. Users will have the ability to assign critical question responses. A critical question is one that has skip/exit logic assigned to a particular response. Within the survey, if the critical response is chosen, the user is exited from the survey. With release 18.2, any surveys already scored in the system will need to have their scoring updated to the new methodology. When authenticated against SurveyGizmo, Select supports the following question types for survey scoring: Radio button Dropdown menu Checkboxes Net promoter score Rating (Likert scale) Image (select one) Image (multi select)
site and investigator scoring	Scoring for sites and investigators has been enhanced as follows: Study administrators can now configure how empty data fields are handled in site scoring. The administrator can choose to score an empty field in the 0th or 50th percentile. For studies involving composite data sources, Select now calculates an Investigator score, which is the average of all site scores for the site's investigator. This score is listed for each of the investigator’s sites.
site disinterest list of values	Administrator users can now define and order the list of values which a site will be required to pick from if they express disinterest in a study. This is performed at the study level. Any changes to the content of the list (add, remove, edit wording of options) will not affect previous site answers, but will be reflected in the disinterest list display for sites moving forward.
sites/studies grid filters	With release 18.2, Select includes the following enhancements to sites/studies grid filters: The filter panel that previously displayed to the left of the sites grid in the nominate step has been removed. A new filter modal design has been added to all four steps of Select’s workflow: nominate, evaluate, select, and finalize. The site grid now consumes the width of the page for all steps. Select now includes the following new filters and filter options: If a date column is set up to display in the site selection workflow data grid, users can now optionally filter by a date or date range. In the evaluate, select, and finalize steps, users can apply Site progress and/or Survey analysis filters. If filters are applied to the site grid, the filter icon will change to a green color.
email templates	A new email template option allows users to send site invitations to all available contacts associated with a site record, with the exception of the IRB coordinator identified in the site file. When using this option, invitations will be sent to every known email address associated with selected sites; however, Acceptance and Decline emails are sent only to active Select LITE users. Additionally, we updated study invitation email templates to include a link to the goBalto Terms of Service.
team assignments	At the study level, users can now be assigned to sites in the evaluation and select steps. The assigned user’s email overrides the default email address for invitation and correspondence emails sent from Select. Site grid filters also include the ability to filter on a site’s assigned user.
data refresh logs	Data refresh logs now display the data source name in human-readable format and the date and timestamp of last refresh.
Site Progress tab	With release 18.2, Select introduces a new Site Progress tab in the select step, which increases visibility of a site’s progress from invitation through assigned workflow tasks. Users can now view task progress at a glance via standard Select progress icons or hover over an individual progress icon to view details and notes about the progress indicator, if available. For example: users can hover over an icon in the “Invitation Received” column to see details about the recipient, each email attempt, and email status (sent, deferred, bounced, dropped, delivered, opened, and/or clicked).   users can hover over a task icon to view detail for completed tasks, including the user who completed the task, his or her role, date completed, and any system-generated notes.
Survey Analysis tab	Select now includes a redesigned Survey analysis tab that allows users to evaluate category scoring (an aggregated question score) at a glance. Category scores display as color valued cells, with higher scores represented as a darker green value. Questions whose responses have triggered a critical response are indicated with a red mark in the cell. Users evaluating scores can hover over an individual cell to display the category point score or click the cell to access question, answer, and point value details.
site selection	Select release 18.2 introduces multiple selection enhancements to streamline workflows, improve interactions with site data, and improve data exports. These enhancements include: a new intermediary state, Review, in the site nominations workflow. Review is a stage where a site identification specialist can review sites prior to nomination or shortlisting. the ability to undo nomination or shortlisting. For a site that has been nominated or shortlisted, users are now able to undo the nomination of a site and place it back in the Review state on step 1. From Review, a user can also send the site back to the master list. the ability to shortlist sites from the master list and send sites directly to the evaluate page shortlist. an updated column picker with a new display layout. display of up to 50 rows per page in the site data grids for all steps. increased character count for Protocol Name on the Study Details page. The maximum characters allowed increased from 36 to 100 characters. an upper limit for any selection action on a list of sites. The limit is now 400 sites for any stage in Select. a modified invited site CSV export in the select step, which now supports up to 5,000 rows.
preferred site workflow	With release 18.2, Select introduces a new preferred site workflow to allow CRO preferred sites to be added to a study. For example: a study’s parameters limit the master list of sites to contain sites from Germany and France. The sponsor wishes to include a small number of sites from Mexico. The Select user can upload a CSV of the site records from Mexico and select the option to bypass study parameter filters. The master list will contain the full list of preferred sites, regardless of the filter criteria specified on the Manage study details page. Site identification specialists and feasibility specialists can upload and map a CSV format file of CRO preferred sites and enable a “Preferred sites” workflow option on the Manage study details page. When preferred sites are located in a study, a new column, “Preferred Site,” displays with a star icon next to each site. Users can sort and filter on the column.
investigator opt-out	With release 18.2, Select introduces opt-out functionality for investigator records. An investigator's record may be opted-out (removed from usage) from Select at the account level. All sites related to an investigator will be filtered from view and will not receive an invitation or re-invitation email from Select for that account. Investigator opt-out must be performed with data file import/update. For CSV files: an investigator can be removed by mapping "DPA refused" to investigator_status_reason data field. All sites related to that investigator record must be updated. Restore an investigator by sending an updated investigator record in which the "DPA refused" text in the investigator_notes field has been changed or removed. For composite data files: an investigator can be removed by mapping "DPA refused" to investigator_status_reason. Restore an investigator by sending an updated investigator record in which the "DPA refused" text in the investigator_status_reason field has been changed or removed.
Select Analyze reports	Users who are provisioned for goBalto Analyze access are now able to connect to Analyze from the Select Dashboard menu. The user will see the Select Analyze reports for which he or she has view permissions.
workflow tasks	We made the following changes to workflow functionality: Users who define workflows and specify a new workflow name, must now specify a unique name. Select will prevent users from duplicating a workflow name that already exists in the account. When defining a workflow, users can now choose Generic Document from the Task Library. The Generic Document task allows users to upload a document and specify a document name that will be visible to sites. Once uploaded, Select users can access the document from the setup menu “CDAs, confidentiality documents, and generic documents” option, where the generic document can be attached to a workflow.
other enhancements	Additional enhancements are part of the 18.2 release and include: Select and Select LITE login pages now include links to the goBalto Terms of Service and Privacy Policy. We have exposed the Select data import APIs for customer use. A link to the API documentation is available within the Select platform via the help dropdown in the upper right corner. Users who have the appropriate business permission can access Select product documentation in the new goBalto Help Center. A link to the Help Center is available within the Select platform via the help dropdown in the upper right corner.

bugs fixed in this release

description		ticket	priority
browser compatibility	When using the IE11 browser, the user could not single click on the field to type in a new reason option for site disinterest on the Manage reasons for disinterest page.	SEL-3464	normal
	When using the IE11 browser and hovering over an incomplete workflow, the workflow options and tooltip did not display as expected.	SEL-2998	normal
	When using the IE9 browser, an error occurred when users attempted to upload a document in the Sign and return CDA task.	SEL-4174	high
	When using the IE9 browser, the reasons for disinterest list did not display the full text of the disinterest reason.	SEL-4173	high
CDA documents	An error prevented users from uploading a new CDA on the country approval “Required resubmission” tab.	SEL-3639	normal
dashboards	Resent invitations did not display as expected in the email dashboard graph.	SEL-3548	low
	The number of sites reported on in the site email dashboard was limited to 5,000 sites. The number is now unlimited and performance enhancements improved loading time of the email dashboard report.	SEL-2973	high
data source	In data source mapping, users were not prevented from mapping a string field to an incompatible string array field.	SEL-3546	normal
milestones	When entering the number of subjects for study-level milestones, the number was not correctly distributed to country-level milestones.	SEL-3545	normal
protocol documents	An error prevented users from uploading workflow specific protocol documents after a default protocol document had been previously uploaded.	SEL-3561	normal
site communications	Users with site communications permission saw their sent messages display as unread messages (in bold text) before a site responded.	SEL-2653	normal
site scoring	A warning did not display when scoring methodology was changed after site selection had already begun.	SEL-3376	normal
	When scoring methodology was changed from 0 to 50 for sites that have empty scorable fields, scoring did not update as expected.	SEL-3375	normal
	When scoring methodology was changed from 0 to 50 for sites that have empty scorable fields, the Done button was not enabled to allow users to save the change.	SEL-3373	normal
	Prior to configuring study countries and milestones, the Manage site scoring page displayed options to manage scoring for sites that have empty fields.	SEL-3532	normal
site selection	CSV data exports from the invited list did not specify estimated patient count or SIV date when this data existed in completed workflow tasks.	SEL-3578	normal
	In the nomination step, when a user clicked the site action “Return to master list,” the site was returned to the master list, but should have been returned to the nomination review list. The action button has been relabeled “Move to Nominate - Review.”	SEL-3178	normal
	When moving a site back from the evaluate step, the confirmation text displayed “moved to Review.” This confirmation text has been updated to “Moved to Nominate - Review.” The action button has been relabeled “Move to Nominate - Review.”	SEL-3555	low
	The name of the user who moved a site to the short list was not displayed as expected in the site grid’s “Short List By” column.	SEL-3335	normal
	List totals did not dynamically update as concurrent users moved sites from one list to another (e.g., from nominate to review).	SEL-3497	normal
survey analysis	CSV data exports from the survey analysis tab did not contain survey completion dates for sites that had completed the survey, although that data appeared in Select.	SEL-3530	high
user interface	The Actions column was not always the final column displayed in the sites grid.	SEL-1767	normal
	If a date column was selected for display in the sites grid after data source import, it displayed in raw date-time format instead of the standard date format (mm/dd/yyyy).	SEL-3183	normal
	When selecting a country on the Manage study details page, the type ahead search feature did not allow the user to arrow down through the results list to select a country.	SEL-2499	low
	The site data grid and “Add to” action buttons above it were not properly aligned in the evaluate, select, and finalize steps.	SEL-2808	normal
	After performing an action (such as re-invite sites) on selected sites, the sites were not automatically deselected.	SEL-3558	high

hotfix 18.2.0.5 available for this release 11AUG2018

bugs fixed in 18.2.0.5

description		ticket	priority
infrastructure	We made a change to improve performance of scoring and list of values population for studies with large datasources.	SEL-4716	high

hotfix 18.2.0.4 available for this release 08AUG2018

bugs fixed in 18.2.0.4

description		ticket	priority
infrastructure	We made a change to improve performance of data disambiguation.	SEL-4660	high

hotfix 18.2.0.3 available for this release 31JUL2018

bugs fixed in 18.2.0.3

description		ticket	priority
infrastructure	We made a change to stabilize performance of data import to Select.	SEL-4621	normal

hotfix 18.2.0.2 available for this release 18JUL2018

bugs fixed in 18.2.0.2

description		ticket	priority
scoring	We made a database change to improve performance of the scoring application.	SEL-4500	normal
master list	After setting study parameters, the master list now populates immediately with the filtered list of sites and is no longer delayed by scoring activity. To view site scores after calculation, refresh the page.	SEL-4496	high

hotfix 18.2.0.1 available for this release 02JUL2018

bugs fixed in 18.2.0.1

description		ticket	priority
infrastructure	We made an internal database change to resolve a datasource mapping error.	SEL-4396	normal

known issues

new items

description		ticket	priority
filter	Trial FPI filter is not reflected as an available filter option.	SEL-4119	normal
	Drugs tested filter is not reflected as an available filter option.	SEL-4114	normal
	Sponsor filter is not returning sites as designed.	SEL-4072	normal
	If only a start or end date is entered into a date range filter, the style of the filter button does not change to indicate that there is currently an active filter.	SEL-4336	normal
milestones	Country level milestones do not automatically populate when adding dates to the study.	SEL-3831	normal
roles and permissions management	Search is not functional on the Manage users and roles page.	SEL-4130	normal
site selection	The CSV export generated from the Evaluate page on-hold tab displays the user ID in the on_hold_by column rather than the user name.	SEL-4135	normal
user interface	On the Manage Study Details page, Indication and Phase criteria should display only for composite data sources not regular data sources.	SEL-4208	normal
	On the Manage study details page, the Preferred sites option description text indicates sites will be moved automatically to the evaluation short list when sites always display on the Master list.	SEL-3827	low
	On the Manage CDA page, text for “No previous versions” and “Confidentiality statements”' overlap in the user interface.	SEL-4142	low
	Study level milestones fields should not be highlighted in red by default in milestones page.	SEL-4141	normal
	The site progress tab’s icon key erroneously displays on the survey analysis tab.	SEL-3987	normal
	On the site grid, the search free text field’s cross (X) icon is not responsive. Workaround: manually delete the text from the search field and press enter.	SEL-4134	normal
	Clicking the Cancel button in the Notes pop-in results in an error.	SEL-3935	low
workflow	If a generic document workflow task is not gated, the task will be visible to Select LITE users at all times. The user will not have to achieve that step in the workflow before the task is visible.	SEL-4374	normal
	When a user changes a site’s workflow from the invited list on the site progress tab, the task list icons do not reflect the newly assigned workflow for that site. Workaround: refresh the page to view the updated task list icons.	SEL-4326	normal
	When a user changes a site’s workflow from the short list, the selected workflow does not immediately display. Workaround: refresh the page to view the updated workflow.	SEL-4327	normal
	Adding a workflow close date applies the close date only to new site invitations.	SEL-4328	normal
	Currently, when changing the workflow for a site in the site grid, a user must refresh the browser page for the change to take effect.	SEL-4392	normal
	Missing tasks (e.g., Upload protocol and Manage email templates) should block users from inviting sites.	SEL-4004	normal

previously reported items

description		ticket	priority
browser compatibility	When using the IE9 browser, the Setup menu navigation dropdown is slightly illegible because the text is too light to read.	SEL-1328	low
	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.	SEL-2042	low
	When using the IE11 browser, on the Manage Workflow page, you cannot select text or position your cursor anywhere in a text field using your mouse. Workaround: To select text, the user must either use Ctrl-A or tab into the field from another field.	SEL-2642	normal
document library	Authenticated Select LITE users will see an Attach button in the Document Library that only partially displays, but is still functional.	SEL-2492	normal
invited sites analysis	CSV data exports from the Invited tab of site selection step 3 incorrectly displays a numerical ID in the Invited By column, not the name of the user who invited the site.	SEL-3590	high
milestones	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.	SEL-2474	normal
roles	When you navigate to another page within the Users table, the sort order you selected on the previous page will not be applied to the next page.	SEL-2217	low
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.	SEL-3630, SEL-3631	normal
site communications	Users with site communications permission will see their sent messages display as unread messages before a site has responded.	SEL-2653	normal
site management	Three standard fields are not displayed in the Site Profile tab: Clinical Trial Center, Other, and Preselection Contact Okay?	SEL-2142	high
task management	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.	SEL-2225	normal
usability	Minor styling issues on survey workflow pages.	SEL-582, SEL-603	low
user interface	When the user’s browser window is only slightly wider than the site data grid, the Actions menu is only partly visible when opened. Workaround: Scroll right to view the rest of the menu.	SEL-3510	low
	The site grid persistently maintains a height of 50 rows (the new maximum), rather than dynamically resizing to fit a lesser number of rows if fewer than 50 sites are visible.	SEL-3496	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

The list of supported browsers has not changed with the 18.2 release. For details, see the goBalto Browser support article.

open source attribution

goBalto uses certain third party open source software in connection with goBalto Select. For details, see the goBalto Open source attribution article.

article revision history

date	description
06NOV2018	REMOVED Select Analyze reports from 18.2 new in this release section. These reports were included in the release notes but required additional development and have not yet been released.
03OCT2018	ADDED link to Open source attribution article under a new technical information section.
20AUG2018	CORRECTED survey scoring section to update supported SurveyGizmo question types.
11AUG2018	ADDED release notes for hotfix 18.2.0.5.
08AUG2018	ADDED release notes for hotfix 18.2.0.4.
01AUG2018	ADDED release notes for hotfix 18.2.0.3.
23JUL2018	ADDED additional items to the new known issues table.
18JUL2018	ADDED release notes for hotfix 18.2.0.1 and hotfix 18.2.0.2
16JUL2018	CORRECTED description of Investigator opt-out feature, which previously indicated that the feature is supported only for composite data sources. This feature is also supported for CSV as described.

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