Oracle Accessibility Conformance Report

VPAT® Version 2.3 - April 2019

Name of Product:

Oracle Health Sciences Empirica Topics and Signal Management 9.1

Product Description:

There are two components of this product that can be configured separately.

Empirica Topics is a workflow application where users in a work team can collect issues into topics and actions and process them through different states in the workflow. States have fields such as text, date, or numeric fields dropdown fields, or pick lists that user complete to proceed to another state. When a topic is complete, it is moved to a closed state. Topic Management in Empirica Signal represents Empirica Topics.
Empirica Signal Management is a statistical analysis tool used by the pharmaceutical industry and regulators to review post-marketing safety data for particular monitored drugs on a routine basis. Results are presented in tabular form and optionally in graphical form. Forms are available for user input. Signal Review in Empirica Signal represents Empirica Signal Management.

Both of these components require the base Empirica Signal product.

Date:

25-Aug-2020

Archive Note:

This VPAT applies to only version 9.1. It does not apply to any versions of Oracle Health Sciences Empirica Topics and Signal Management after this. This VPAT has been superseded by Oracle Health Sciences Empirica Topics and Signal Management 9.2.1.

Contact Information:

accessible_ww@oracle.com

Notes:

This VPAT does not cover the following product areas:

In Empirica Signal Management
- Sector map graphs (accessible alternative is using tabular data mining results)
- Report graphs (accessible alternative is using tabular reports)
- Administrative tasks for Signal Management performed from the settings page such as signal management configuration, managing signal refresh runs, and managing signal review users.

Dependent Products

This product interacts with or is built with the other Oracle products listedin this section. Click below to view information about the accessibility ofthese dependent products. Products listed are the versions available at thetime of publication of this document; newer documents may be available that supersedethese versions.

Evaluation Methods Used:

Oracle's policy is to design, develop and test both products and documentation to be accessible. The recommended styles of testing for accessibility include: (i) algorithmic automated tests, (ii) human judgement tests such as tool-assisted tests, visual inspection and manual operation, and (iii) testing with assistive technology by people with and without disabilities. Additional information about Oracle's accessibility program is available on http://www.oracle.com/corporate/accessibility/index.html

Accessibility Standards/Guidelines

This report covers the degree of conformance for the following accessibility standard/guideline:

Standard/Guideline	Included In Report
Web Content Accessibility Guidelines 2.1	Level A - Yes Level AA - Yes Level AAA - No
Revised Section 508 standards published January 18, 2017 and corrected January 22, 2018	Yes

Terms

The terms used in the Conformance Level information are defined as follows:

Supports: The functionality of the product has at least one method that meets the criteria without known defects or meets with equivalent facilitation.
Partially Supports: Some functionality of the product does not meet the criteria.
Does Not Support: Majority of functionality of the product does not meet the criteria.
Not Applicable: The criteria are not relevant to the product.

WCAG 2.1 Report

Table 1 also documents conformance with:

Section 508: Chapter 5 - 501.1 Scope, 504.2 Content Creation or Editing, and Chapter 6 - 602.3 Electronic Support Documentation

Note: When reporting on conformance with the WCAG 2.1 Success Criteria, they are scoped for full pages, complete processes, and accessibility-supported ways of using technology as documented in the WCAG 2.1 Conformance Requirements.

Table 1: WCAG Conformance Criteria

Criteria	Conformance Level	Remarks and Explanations
1.1.1 Non-text Content (Level A)	Supports	This product was tested for: Images that convey information have meaningful alternative text using ALT Images that are decorative are marked up using ALT=”” or CSS background images Information shown in complex images such as charts is also available in an alternative textual form (e.g. a data table) Controls have an associated name Client-side image maps specify the ALT attribute on each AREA element. Non-text characters are not used or have meaningful alternative text No CAPTCHA is used.
1.2.1 Audio-only and Video-only (Prerecorded) (Level A)	Not Applicable	The product has no multimedia.
1.2.2 Captions (Prerecorded) (Level A)	Not Applicable	The product has no multimedia.
1.2.3 Audio Description or Media Alternative (Prerecorded) (Level A)	Not Applicable	The product has no multimedia.
1.2.4 Captions (Live) (Level AA)	Not Applicable	The product has no multimedia.
1.2.5 Audio Description (Prerecorded) (Level AA)	Not Applicable	The product has no multimedia.
1.3.1 Info and Relationships (Level A)	Partially Supports	This product was tested for: User interface component labels are associated with the fields they are labeling Headings are encoded with HTML heading tags Table markup is used for marking up data tables, including row and column headers and table captions/summaries where appropriate Data tables specify SUMMARY or CAPTION Layout tables use appropriate markup Style sheets are used only to change the layout and presentation on the screen. Exception: Bug 19636325 - Create Case Series page - layout table is not marked as presentation
1.3.2 Meaningful Sequence(Level A)	Supports	This product was tested for: The sequence of elements in the DOM matches a logical reading sequence.
1.3.3 Sensory Characteristics(Level A)	Supports	This product was tested for: Instructions provided do not refer to things solely based on their sensory characteristics such as shape, size, visual location, orientation, color, or sound.
1.3.4 Orientation (Level AA)	Supports	This product was tested for: Support of portrait and landscape orientation without loss of functionality or visibility of text. This application supports portrait and landscape orientation and is optimally designed for landscape orientation to view multiple columns in a table without horizontal scrolling. To enhance usage of space, this product supports expanding and collapsing different sections on pages.
1.3.5 Identify Input Purpose (Level AA)	Supports	This product was tested for: Text fields that collect information about the user. No text fields collect information about the user.
1.4.1 Use of Color(Level A)	Supports	This product was tested for: Information conveyed by color is available in alternative formats, such as shape, text, font weight Information conveyed by color has a contrast ratio of at least 3:1.
1.4.2 Audio Control(Level A)	Not Applicable	The product has no multimedia.
1.4.3 Contrast (Minimum) (Level AA)	Supports	This product was tested for: Large-scale text and images of large-scale text have a contrast ratio of at least 3:1 Other text and images of text have a contrast ratio of at least 4.5:1.
1.4.4 Resize text(Level AA)	Supports	This product was tested for: Text can be resized up to 200% without loss of content or functionality.
1.4.5 Images of Text(Level AA)	Supports	This product was tested for: Images of text are only used when the technology can't create the desired visual presentation, the image can be customized or the particular image is essential.
1.4.10 Reflow (Level AA)	Not Supported	This product was tested for: Text information reflows so that only one direction of scrolling is required while at 400% zoom. Content that requires two-dimensional layout only presents scroll bars in the component used to present the two-dimensional content. Exception: Bug 31637061 - Signal and Topics do not support zoom to 400%
1.4.11 Non-text Contrast (Level AA)	Partially Supports	This product was tested for: Non-text items have a contrast ratio of at least 3:1. Data mining and report graphs have colors that can be modified by end users who can choose high-contrast color options. Signal Management alert graphs have colors that can be modified by administrators who can choose high-contrast color options. Topic graphs on the Topic Management have fixed colors and these colors have at least 3:1 contrast between the color and the border of the graph element. Exception: Bug 31769612 - Product Detail Section Open Topics donut chart color contrast not high enough
1.4.12 Text Spacing (Level AA)	Partially Supports	This product was tested for: When the following attributes and no others are modified there is no loss in functionality or content: Line height (line spacing) to 1.5 times the font size Spacing following paragraphs to 2 times the font size Letter spacing (tracking) to at 0.12 times the font size Word spacing to 0.16 times the font size Exception: Bug 31636554 - Bottom of details section title is clipped when Text Spacing styles are overridden.
1.4.13 Content on Hover or Focus (Level AA)	Not Applicable	This product does not provide additional content on hover or focus.
2.1.1 Keyboard(Level A)	Partially Supports	This product was tested for: Ability to perform functions from the keyboard only, and without requiring specific timings for individual keystrokes Proper operation of unique keystrokes and access keys, including those listed in the product documentation The ability to use the product with OS keyboard aids: StickyKeys and FilterKeys (feature names may be different on different platforms). Exception: The Topic Management's Calendar tab's month view does not support keyboard accessibility. The workaround is to use the calendar list view on the left side of the page to access the same information. Bug 31539992 - Topics Calendar tab's month view does not support keyboard accessibility.
2.1.2 No Keyboard Trap (Level A)	Supports	This product was tested for: Movement of focus through each control only using the keyboard, with no "keyboard trap" that prevents focus from moving away from any control.
2.1.4 Character Key Shortcuts (Level A)	Not Applicable	This product does not use character key shortcuts.
2.2.1 Timing Adjustable(Level A)	Supports	This product was tested for: Time limits in the product can be turned off before they are encountered Time limits in the product can be adjusted to at least 10 times longer before encountered Time limits in the product can be extended with at least 20 seconds warning up to 10 times.
2.2.2 Pause, Stop, Hide (Level A)	Supports	This product was tested for: Moving, blinking, or scrolling information that is designed to last for more than five seconds can be paused Moving, blinking, or scrolling content that is pure decoration can be stopped or hidden.
2.3.1 Three Flashes or Below Threshold(Level A)	Supports	This product was tested for: No portion of the screen flickers or flashes with a frequency between 2 Hz and 55 Hz.
2.4.1 Bypass Blocks(Level A)	Supports	This product was tested for: A ‘Skip to Main Content’ link is provided to skip repetitive navigation links at the top of the page Structure and hierarchy is marked up with Header elements outside of repetitive navigation links.
2.4.2 Page Titled(Level A)	Supports	This product was tested for: Pages have a meaningful title specified in the TITLE element.
2.4.3 Focus Order(Level A)	Partially Supports	This product was tested for: Logical movement through the focusable components using only the keyboard, in an order that follows a meaningful sequence. Exception: Bug 19636656 - sigInteractionsPopup.jsp graph menus not optimal with the keyboard The menus on the signal interactions graph do not receive initial focus when the user displays the menu from this graph. The user must tab through each line in the graph until focus is set on the graph menu. At that point, they can use the keyboard to select items on the graph menu. The menu does not display at the optimal location next to the graph line but displays near the mouse cursor.
2.4.4 Link Purpose (In Context)(Level A)	Supports	This product was tested for: The text of links and their surrounding paragraph, list, or table cell (with marked up table headers), is sufficient to describe their purpose.
2.4.5 Multiple Ways(Level AA)	Supports	This product was tested for: Pages are fully inter-linked to each other Page contains controls that enable reaching pages.
2.4.6 Headings and Labels(Level AA)	Supports	This product was tested for: Headers describe the topic or purpose of the content below them Labels describe the purpose of the associated field.
2.4.7 Focus Visible(Level AA)	Supports	This product was tested for: Visual indication of the location of the focus.
2.5.1 Pointer Gestures (Level A)	Not Applicable	This product does not use multipoint or path-based gestures.
2.5.2 Pointer Cancellation (Level A)	Supports	This product was tested for: Pointer cancellation and that mouse up after mouse down events are used to complete operations.
2.5.3 Label in Name (Level A)	Supports	This product was tested for: Images that include text. Alt text or aria labels with the text of the images are used for all relevant images. For generated graphs with text, the text data is available in tabular form.
2.5.4 Motion Actuation (Level A)	Not Applicable	This product does not use motion actuation.
3.1.1 Language of Page(Level A)	Supports	This product was tested for: Properly set lang attribute for each page.
3.1.2 Language of Parts(Level AA)	Not Applicable	This product was tested for: Proper use of lang attribute for text passages that are in a different language than that of the page.
3.2.1 On Focus(Level A)	Supports	This product was tested for: When an element receives focus, it does not result in a substantial change to the page, an additional change of keyboard focus, or the spawning of a pop-up window.
3.2.2 On Input(Level A)	Supports	This product was tested for: Changes in the value of user interface components does not result in a substantial change to the page, an additional change of keyboard focus, or the spawning of a pop-up window.
3.2.3 Consistent Navigation(Level AA)	Supports	This product was tested for: Pages that are grouped together into sets with a common navigation mechanism utilize that navigation mechanism in the same fashion, with navigation elements appearing in the same relative order each time.
3.2.4 Consistent Identification(Level AA)	Supports	This product was tested for: Images and controls are used and identified consistently throughout the product.
3.3.1 Error Identification(Level A)	Supports	This product was tested for: When input errors are detected, they are described to the user in text, including identifying the item where the error occurred.
3.3.2 Labels or Instructions (Level A)	Supports	This product was tested for: Labels or instructions are provided when the product requires user input.
3.3.3 Error Suggestion (Level AA)	Supports	This product was tested for: Where suggestions for fixing an input error are known, they are provided to the user.
3.3.4 Error Prevention (Legal, Financial, Data)(Level AA)	Supports	This product was tested for: Submissions can be reversed by the user Data is checked for input errors with an opportunity for the user to correct them Data can be reviewed, corrected, and confirmed by the user before they are finalized.
4.1.1 Parsing(Level A)	Partially Supports	This product was tested for: Elements in HTML content have complete start and end tags, are properly nested, do not contain duplicate attributes, and have unique IDs Pages validate to the HTML specification. Exception: Bug 30045365 - tables with multi-column headers have duplicate IDs
4.1.2 Name, Role, Value (Level A)	Supports	This product was tested for: HTML controls have a programmatically associated name, derived from the appropriate HTML elements and attributes including LABEL, TITLE, SUMMARY Additional state information is programmatically exposed for HTML controls, such as whether a field is ‘required’. Frames have a meaningful title specified in the title attribute.
4.1.3 Status Messages (Level AA)	Supports	This product was tested for: ARIA status role for status messages that are added to a page.

2018 Section 508 Report

Chapter 3: Functional Performance Criteria (FPC)

Criteria	Conformance Level	Remarks and Explanations
302.1 Without Vision	Not Applicable	The product does not rely on equivalent functionality, and all aspects are addressed by the technical standards.
302.2 With Limited Vision	Not Applicable	The product does not rely on equivalent functionality, and all aspects are addressed by the technical standards.
302.3 Without Perception of Color	Not Applicable	The product does not rely on equivalent functionality, and all aspects are addressed by the technical standards.
302.4 Without Hearing	Not Applicable	The product does not rely on equivalent functionality, and all aspects are addressed by the technical standards.
302.5 With Limited Hearing	Not Applicable	The product does not rely on equivalent functionality, and all aspects are addressed by the technical standards.
302.6 Without Speech	Not Applicable	The product does not rely on equivalent functionality, and all aspects are addressed by the technical standards.
302.7 With Limited Manipulation	Not Applicable	The product does not rely on equivalent functionality, and all aspects are addressed by the technical standards.
302.8 With Limited Reach and Strength	Not Applicable	The product does not rely on equivalent functionality, and all aspects are addressed by the technical standards.
302.9 With Limited Language, Cognitive, and Learning Abilities	Not Applicable	The product does not rely on equivalent functionality, and all aspects are addressed by the technical standards.

Chapter 4: Hardware

These criteria are all Not Applicable because the product is not Hardware

Chapter 5: Software

Criteria	Conformance Level	Remarks and Explanations
501.1 Scope - Incorporation of WCAG 2.0 AA	Supports	See the responses in the WCAG 2.0 section of this report.
502 Interoperability with Assistive Technology	Heading cell - no response required	Heading cell - no response required
502.2.1 User Control of Accessibility Features	Not Applicable	The product is not a platform or does not have access to platform accessibility features.
502.2.2 No Disruption of Accessibility Features	Not Applicable	The product is designed to be isolated from the underlying platform.
502.3 Accessibility Services	Heading cell - no response required	Heading cell - no response required
502.3.1 Object Information	Not Applicable	The product is not a platform or does not have access to platform accessibility features.
502.3.2 Modification of Object Information	Not Applicable	The product is not a platform or does not have access to platform accessibility features.
502.3.3 Row, Column, and Headers	Not Applicable	The product is not a platform or does not have access to platform accessibility features.
502.3.4 Values	Not Applicable	The product is not a platform or does not have access to platform accessibility features.
502.3.5 Modification of Values	Not Applicable	The product is not a platform or does not have access to platform accessibility features.
502.3.6 Label Relationships	Not Applicable	The product is not a platform or does not have access to platform accessibility features.
502.3.7 Hierarchical Relationships	Not Applicable	The product is not a platform or does not have access to platform accessibility features.
502.3.8 Text	Not Applicable	The product is not a platform or does not have access to platform accessibility features.
502.3.9 Modification of Text	Not Applicable	The product is not a platform or does not have access to platform accessibility features.
502.3.10 List of Actions	Not Applicable	The product is not a platform or does not have access to platform accessibility features.
502.3.11 Actions on Objects	Not Applicable	The product is not a platform or does not have access to platform accessibility features.
502.3.12 Focus Cursor	Not Applicable	The product is not a platform or does not have access to platform accessibility features.
502.3.13 Modification of Focus Cursor	Not Applicable	The product is not a platform or does not have access to platform accessibility features.
502.3.14 Event Notification	Not Applicable	The product is not a platform or does not have access to platform accessibility features.
502.4 Platform Accessibility Features	Not Applicable	The product is not a platform or does not have access to platform accessibility features.
503 Applications	Heading cell - no response required	Heading cell - no response required
503.2 User Preferences	Not Applicable	The product is designed to be isolated from the underlying platform.
503.3 Alternative User Interfaces	Not Applicable	The product does not have assistive technology features.
503.4 User Controls for Captions and Audio Description	Heading cell - no response required	Heading cell - no response required
503.4.1 Caption Controls	Not Applicable	The product has no multimedia.
503.4.2 Audio Description Controls	Not Applicable	The product has no multimedia.
504 Authoring Tools	Heading cell - no response required	Heading cell - no response required
504.2 Content Creation or Editing	Not Supported	PDF files created by the system do not conform to WCAG 2.0. Bug 31781782 - Create Topic PDF - generated PDF is not accessible Bug 31781815 - Download tables to PDF - generated PDF is not accessible
504.2.1 Preservation of Information Provided for Accessibility in Format Conversion	Not Supported	Product does not preserve accessibility info when converting content to PDF. Bug 31781782 - Create Topic PDF - generated PDF is not accessible Bug 31781815 - Download tables to PDF - generated PDF is not accessible
504.2.2 PDF Export	Not Supported	The product does not export PDF compatible with PDF/UA-1. Bug 31781782 - Create Topic PDF - generated PDF is not accessible Bug 31781815 - Download tables to PDF - generated PDF is not accessible
504.3 Prompts	Not Supported	The product does not prompt for accessibility information during document creation. Bug 31781782 - Create Topic PDF - generated PDF is not accessible Bug 31781815 - Download tables to PDF - generated PDF is not accessible
504.4 Templates	Not Applicable	No templates are provided for Create Topic PDF or Download for tables

Chapter 6: Support Documentation and Services

Criteria	Conformance Level	Remarks and Explanations
602 Support Documentation	Heading cell - no response required	Heading cell - no response required
602.2 Accessibility and Compatibility Features	Not Applicable	The product uses standard operating system keystrokes to operate controls and does not have any special accessibility and compatibility features.
602.3 Scope - Incorporation of WCAG 2.0 AA	Supports	See the responses in the WCAG 2.0 section of this report.
602.4 Alternate Formats for Non-Electronic Support Documentation	Not Applicable	Product documentation is in electronic format.
603 Support Services	Heading cell - no response required	Heading cell - no response required
603.2 Information on Accessibility and Compatibility Features	Supports	Oracle Global Customer Support can provide information about accessibility features of the product.
603.3 Accommodation of Communication Needs	Supports	Oracle customers have access to electronic support through My Oracle Support or by calling Oracle Support at 1.800.223.1711. Hearing-impaired customers in the U.S. who wish to speak to an Oracle Support representative may use a telecommunications relay service (TRS). Information about the TRS is available at http://www.fcc.gov/cgb/consumerfacts/trs.html, and a list of telephone numbers is available at https://www.fcc.gov/general/telecommunications-relay-services-directory. International hearing-impaired customers should use the TRS at +1.605.224.1837. An Oracle Support engineer will respond to technical issues according to the standard service request process.

Oracle Legal Disclaimer

The information above describes this product's ability to support the applicableStandards/Guidelines, subject to Oracle's interpretation of those standards(available at https://www.oracle.com/corporate/accessibility/policy.html#standards-tab) and the remarks in this document. For more information regarding the accessibility status of this product or other Oracle products, see http://www.oracle.com/corporate/accessibility or contact: accessible_ww@oracle.com.

This document is provided for information purposes only and the contents hereof are subject to change without notice. Oracle Corporation does not warrant that this document is error free, nor does it provide any other warranties or conditions, whether expressed orally or implied in law, including implied warranties and conditions of merchantability or fitness for a particular purpose. Oracle Corporation specifically disclaims any liability with respect to this document and no contractual obligations are formed either directly or indirectly by this document. Oracle further makes no representation concerning the ability of assistive technologies or other products to interoperate with Oracle products. This document addresses the named product(s) only and not prerequisite products for which Oracle supplies restricted use licenses.