This feature brief describes what's coming in the 18.2 release of goBalto Select. We've included the following sections:
- Composite trial-site data model
- Studies tab
- SurveyGizmo integration
- Survey Scoring enhancements
- Site and investigator scoring
- Site disinterest list of values
- Sites/Studies grid filters
- Email templates
- Team assignments
- Data refresh logs
- Site Progress tab
- Survey Analysis tab
- Site selection enhancements
- Preferred site workflow
- Investigator opt-out
- Select Analyze reports
- Additional Select enhancements
- The list of supported browsers has not changed with the 18.2 release. For details, see the goBalto Browser support article.
- This brief gives you early insights into the upcoming Select release. All features are subject to change upon release.
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, and 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.
An example of this enhancement is that 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.
Similarly, 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.
New study detail filters
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 will not display.
We added 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
Select now integrates with SurveyGizmo as an additional survey provider option. SurveyGizmo provides advanced functionality such as 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. Additionally, 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 enhancements
We enhanced survey scoring functionality to calculate 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 also 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.
Additionally, Select now supports the following SurveyGizmo question types for survey scoring: radio buttons, dropdown menu, checkboxes, text box, essay, email, date, slider, net promoter score, rating (Likert scale), number, percent, image (select one), and image (multi-select).
Site and investigator scoring
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 for a site's 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, 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, and the site grid now consumes the width of the page for all steps. We also added 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.
On the email templates page, we added a new salutation option for using a contact’s last name only in an email greeting for site communications. We also added an option 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.
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
We added a new Site Progress tab to the select step to increase visibility of a site’s progress from invitation through assigned workflow tasks. Users can 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 clicked).
Similarly, 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
We redesigned the Survey analysis tab to allow users to evaluate category scoring (an aggregated question score) at a glance. Category scores now display as color valued cells, with higher scores represented as a darker value and incorrectly answered critical responses indicated with a red marker 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 enhancements
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
Release 18.2 includes a new Preferred site workflow that allows CRO preferred sites to bypass study parameter filters and move into the Master List. 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. This column can be sorted and filtered on.
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.
An investigator's record may be removed/opted-out 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. This feature is limited to customers leveraging the composite data model and must be performed within the investigator data file import. An investigator can be restored by removing the flag on the investigator's record.
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.
Release 18.2 includes two new reports: Survey Analysis and Study Notes. Additionally, we enhanced the existing Study site interest, Days to complete survey, and Site progress reports to include site-related data.
Additional Select enhancements
Additional enhancements are part of the 18.2 release and include:
- 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 appropriate permissions 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.
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