DFweb User Guide

Release 5.1.0

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The information in this document is furnished for informational use only and is subject to change without notice. DF/Net Research, Inc. assumes no responsibility or liability for any errors or inaccuracies in this document or for any omissions from it.

All products or services mentioned in this document are covered by the trademarks, service marks, or product names as designated by the companies who market those products.

Feb 01, 2019

Abstract

This guide describes the DFweb application.

The instructions are intended to describe, in general terms, how data entry tasks are performed using DFweb. The guidance provided here is not meant to replace more specific instructions which may be provided by the sponsor, principal investigator or coordinating site for a particular trial.


Table of Contents

Preface
1. Getting Help
2. DFdiscover Mailing List
3. Conventions
1. Introduction
1.1. What is DFweb?
1.2. Compatible Browsers
1.3. Capabilities
1.4. General Terminology & Interface Elements
1.4.1. Main Application Pages
1.4.2. Responsive Elements
1.4.3. Menus
1.4.4. Dialogs
1.4.5. Locking
1.4.6. Session Timeout
2. Data Entry
2.1. Selecting a Subject
2.2. Navigating the Subject Binder
2.3. Entering Data / Completing a Record
2.3.1. Data Entry Aids
2.3.2. Data Types
2.3.3. Saving Data
2.3.4. Reset Page
2.4. Finding Subject Records
3. Metadata
3.1. Queries
3.1.1. Add Query
3.1.2. Edit Query
3.1.3. Reply to Query
3.1.4. Delete Query
3.1.5. Multiple Queries Dialog
3.2. Add a Data Reason
3.3. Mark a Data Value as Missing
3.4. Resolving Queries
3.5. Managing Documents
3.5.1. Supported Document Types
3.5.2. Reviewing Documents
3.5.3. Adding Documents
3.5.4. Downloading Documents
3.6. Sharing Links
A. Copyrights - Acknowledgments
A.1. External Software Copyrights
A.1.1. DCMTK software package
A.1.2. Jansson License
A.1.3. HylaFAX Facsimile Software
A.1.4. Mimencode
A.1.5. RSA Data Security, Inc., MD5 message-digest algorithm
A.1.6. mpack/munpack
A.1.7. TIFF
A.1.8. PostgreSQL
A.1.9. OpenSSL License
A.1.10. Original SSLeay License
A.1.11. gawk
A.1.12. Ghostscript
A.1.13. MariaDB and FreeTDS
A.1.14. QtAV
A.1.15. FFmpeg
A.1.16. c3.js
A.1.17. d3.js

Preface

DFweb is a web application delivered through a browser interface. Use of DFweb requires a browser that fully supports HTML5.

1. Getting Help

DF/Net Research, Inc.'s Technical Support Department can be contacted Monday to Friday between 9:00 am and 5:00 pm Eastern Time via any of the following methods:


55 Head Street, Suite 403
DundasOntario  L9H 3H8
Telephone: (905) 522-3282
Email: 
URL: www.dfnetresearch.com

2. DFdiscover Mailing List

DF/Net Research, Inc. provides an automated email mailing list for tips, help, and interaction with other DFdiscover users.

To subscribe to the mailing list, complete the simple form found at the DFdiscover User's Group mailing list webpage. It is also possible to unsubscribe from the mailing list by visiting the same webpage.

To submit a message to the mailing list

  1. Subscribe to the list. Message submissions are only accepted from members of the list.

  2. Create your email message.

  3. Send the email message to .

3. Conventions

A number of conventions have been used throughout this document.

Any freestanding sections of code are generally shown like this:

# this is example code
code = code + overhead;

If a line starts with # or %, this character denotes the system prompt and is not typed by the user.

Text may also have several styles:

  • Emphasized words are shown as follows: emphasized words.

  • Filenames appear in the text like so: dummy.c.

  • Code, constants, and literals in the text appear like so: main.

  • Variable names appear in the text like so: nBytes.

  • Text on user interface labels or menus is shown as: Printer name, while buttons in user interfaces are shown as Cancel.

  • Menus and menu items are shown as: File > Exit.

Chapter 1. Introduction

1.1. What is DFweb?

DFweb is a browser-based application that allows users to perform data entry for a DFdiscover study.

1.2. Compatible Browsers

DFweb requires a browser with full HTML5 capabilities. Check your browser’s capabilities at https://html5test.com.

DFweb has been tested with current versions of Chrome, Firefox, and Edge on Windows 10 and Chrome, Firefox, and Safari on OS X 10.12, 10.13 and 10.14. Browser updates are frequently made available by vendors. Please keep your browser up-to-date.

DFweb is not compatible with any version of Internet Explorer, any browser in Windows XP or any browser in Windows 7.

1.3. Capabilities

The main purpose of DFweb is to facilitate data entry at clinical sites particpating in a DFdiscover study without the need for the additional features available in DFexplore. It may also be that a site is unable to install a local application like DFexplore - DFweb is the perfect solution.

DFweb supports several data validation features - legal range checking, type validation, required values, field skipping, missing value coding and also several metadata features - adding, resolving, and editing queries, and adding reasons for data values.

1.4. General Terminology & Interface Elements

DFweb includes several key pages, menus, and dialogs to facilitate data entry. These pages are explained here, and the terminology used in this document and DFweb is defined. More detailed explanations of certain pages and functionality are given in the following sections.

1.4.1. Main Application Pages

1.4.1.1. Login Page

The login page is the initial landing page in DFweb. The login page is accessed from any compatible browser via the URL https://dfweb.dfdiscover.com/login.

Figure 1.1. Login Page

Login Page


To access a study, a successful login is required. Successful login requires valid credentials. Valid credentials include a value for each of DFdiscover Server, Username and Password. Your study sponsor or monitor has provided you with your own unique credentials. After login, all activities are logged with your username. Do not share your credentials with any other user - each user must use their own credentials.

If you already have login credentials for other DFdiscover tools, the login credentials for DFweb are identical.

Once you have entered a value for DFdiscover Server, the login screen may refresh with a standard message from the DFdiscover administrator. This is useful confirmation that you are connecting to the correct server.

Enter your Username and Password exactly as provided. Click Login to continue.

Problems with the login, whether due to a bad password, mistyped server, or anything else, may appear in red text below the login button.

1.4.1.1.1. Cookies

DFweb uses cookies. Cookies are standard technology implemented in all web browsers. They are small pieces of data sent from a web server (the DFdiscover server in this case) and stored on the user's computer by the user's web browser, while the user is browsing. The login page displays a notification and a hyperlink for more detail.

Further details on the usage of cookies in DFweb can also be found at https://www.dfnetresearch.com/cookie-policy/. Click Don't show this again to confirm that you have read the notification and stop it from being shown in that browser again. If you have previously cleared the notification and need to see it again, clear the browser's cookies and site data, and refresh the page.

1.4.1.1.2. Logging Out

To exit from DFweb, choose Logout from the Application Menu. After successful logout, the login window is shown.

When using DFweb, logging out via Logout in the Application Menu is the recommended and most secure way to exit DFweb. Although closing the page ensures your data is safe, it is best practice to logout properly.

1.4.1.2. Overall Application Appearance

In addition to the login page, there are several intermediate pages. The main application page is the primary interface for most data entry tasks.

Figure 1.2. Main DFweb Page

Main DFweb Page

The main application page has the following features:

  • Browser Controls.  Browser controls are specific to each browser and are not part of DFweb. In general, this area contains the URL for the content that is being viewed, buttons to move to the previous page (if one exists), the next page (if one exists) and refresh the current page, and controls for tabbed windows (if supported).

  • Header Panel.  The header panel is available on all pages of DFweb except the login page. It contains options and navigation that are relevant for all pages, including:

    Figure 1.3. Header Panel, Left

    Header Panel, Left


    • Breadcrumb. The breadcrumb is a navigation aid displaying information about the current context as well as simplifying access to other pages in the study via clickable links.

    • Study Logo.  If the study defines a study logo, it appears in the header panel. Otherwise, the DFdiscover logo is displayed.

    • Study Name. This is the name of the selected study. On the studies page, before you have selected a study, this is empty.

    • Study Help. If study help has been defined, appears in the header panel. Click it to display the Study Help Dialog.

    • Login Information. Your username and DFdiscover server appear in the header panel with the format [username]@[server]. On small displays, this information is visible from the application menu, .

    • Application Menu.  The application menu contains several generic functions that are not study specific, including Logout. See Application Menu for more information.

    Figure 1.4. Header Panel, Right

    Header Panel, Right


  • Main Panel.  The main panel contains the primary information and interaction for the current page. Pages that may appear here are the Studies Page, Sites Page, Subjects Page, and Subject Binder.

1.4.1.3. Studies Page

Figure 1.5. Studies Page

Studies Page

The Studies Page is the first page you navigate to after successful login. It lists the studies you have permissions for. Click one of the available studies to choose that study as the current study. This takes you to the Sites Page for that study.

If you have permissions for exactly one study, this page is bypassed, going to the Sites Page.

The study's number, name, and status are displayed on each line. If the study is not available, the reason is displayed in red in the status column. Not all issues can be discovered before entering the study. If such a problem exists, after selecting the study you are notified of the issue with an alert dialog and returned to the studies page, where the issue is also presented in the status column.

1.4.1.4. Sites Page

Figure 1.6. Sites Page

Sites Page

The Sites Page contains a list of the sites you have permission for. The site number and label are shown on each line. Click one of the sites to make it the active site. This takes you to the Subjects Page for that site.

If you have permissions for exactly one site, this page is bypassed, going to the Subjects Page.

1.4.1.5. Subjects Page

Figure 1.7. Subjects Page

Subjects Page

The Subjects Page contains a list of permitted subjects. Click a subject to change the focus to the subject binder. The icon to the left of the subject ID shows the current status of the subject binder. The status may change over the duration of the study as more visits become required and further data review takes place.

  • The subject binder is final, all data required at this time has been submitted, and there are no outstanding responses or missing, required values.

  • The subject binder is incomplete. There may be missing, required values, illegal values or unresolved questions about the data.

  • The subject binder is pending. There is at least one document attached to the subject ID, but otherwise there is no data yet.

  • There is no data for this subject, or the subject has not yet been saved.

50 subjects are displayed by default. Click Show More to show all subjects. Click Show Less to return to the first 50.

The Subjects Page also provides the following functionality:

  • Search Bar. The search bar allows you to quickly navigate to a subject with a given subject ID. As you type, the list of subjects automatically filters to show only those subjects containing what you have entered. Click Enter to open the Subject Binder for the first filtered subject.

  • Add Subject. Click to open the Add Subject Dialog.

  • Sorting. Click or to change the sort order. This toggles between increasing and decreasing subject ID ordering. indicates that currently the subject IDs are sorted numerically in ascending order. indicates that the current sort order is descending.

1.4.1.6. Subject Binder

The Subject Binder contains all the information of the visits and plates related to a subject. The initial page you are taken to is the first visit and CRF for the subject. Further details regarding the Subject Binder can be found in Chapter 2, Data Entry and Chapter 3, Metadata. An overview is provided here.

1.4.1.6.1. Sidebar

Figure 1.8. Subject Binder Sidebar

Subject Binder Sidebar

The Sidebar displays the current subject, visit, and CRF, as well as providing navigation between CRFs and visits. The current subject is displayed at the top of the Sidebar. The rest of the Sidebar displays all the visits for this subject that you have permission to view. The current visit is expanded to show all the CRFs in that visit that you have permission to view. CRFs are indented slightly from the visits to help visually differentiate them. CRF and visit labels follow the format [Number]: [Label].

Each visit and CRF has an icon that displays its current status. The meanings of the icons are:

  • - This CRF or visit is final, and it is a required CRF or visit.

  • - This CRF or visit is incomplete, and it is a required CRF or visit.

  • - This CRF or visit is pending, and it is a required CRF or visit.

  • - This CRF or visit has not been saved, and it is a required CRF or visit.

  • - This CRF or visit is final, and it is an optional CRF or visit.

  • - This CRF or visit is incomplete, and it is an optional CRF or visit.

  • - This CRF or visit is pending, and it is an optional CRF or visit.

  • - This CRF or visit has not been saved, and it is an optional CRF or visit.

  • - This CRF or visit is final, and it is an unexpected CRF or visit.

  • - This CRF or visit is incomplete, and it is an unexpected CRF or visit.

  • - This CRF or visit is pending, and it is an unexpected CRF or visit.

Click a CRF in the current visit to make it the current and displayed CRF. Click another visit to make that visit current and to display the first CRF in that visit.

1.4.1.6.2. Form

Figure 1.9. Data Entry Form

Data Entry Form

The main part of the page contains the data entry form. This form allows you to view, add and modify data, queries, reasons, and missing value codes, and view and add documents to the CRF.

Figure 1.10. Data Entry Form Header

Data Entry Form Header

At the top of the form is a header area for CRF-wide actions. The header remains visible as you scroll through the CRF contents. It contains:

  • CRF Label. The CRF label is composed of the CRF number and label. These follow the format [Number]: [Label].

  • CRF Help. If CRF help has been provided for this CRF in the study setup, appears in the header area. Click to open the CRF Help Dialog.

  • Locked CRF Icon. If the CRF is in use by another user, appears to the left of Save. This indicates that no editing can be done on this CRF.

  • CRF Menu Button. Click or to open the CRF Menu, which contains CRF level options such as managing the documents and resetting the form.

  • Save Button. Click Save to save the changes you have made to the current CRF and submit them to the server. Save is disabled if no changes have been made to the form. Hover your mouse over Save to display a tooltip with the last saved time and the CRF status.

The remainder of the form is filled by screens, which appear as vertically stacked tabs. Click the corresponding tab to close any screen. The tab with the input focus cannot be closed.

Figure 1.11. Data Entry Form

Data Entry Form

Figure 1.12. Data Entry Form 2

Data Entry Form 2

Each screen is composed of rows of fields. Each field can contain:

  • Field Input. Each field has an input area. The type of input determines exactly what appears in this area. For more information on input types, see Data Types.

  • Date Picker. Date fields have a date picker (). Click to reveal a calendar. Picking a date in the calendar is equal to typing it in the Field Input.

  • Field Help. If the study setup has defined help for the field, is visible. Click to display a help tooltip, which can be dismissed by clicking any other area of the page.

  • Modified Data Indicator. If a value in the field is unable to be displayed in the input area, it is modified when you open the CRF. shows which fields have been modified. Click the indicator to display more information about the change.

  • Required Indicator. If the field is required or essential, appears on the line. Fields with this indicator display a warning message if left blank.

  • Reset Button. Choice (Radio Button) and VAS input areas have Reset. This can be used to set the field back to the blank value.

  • Field Label. The field label shows the field prompt, if it is available. Otherwise the field description is used for the label.

  • Metadata Indicators. Q, R, and M are displayed on each line. They allow the user to add, modify and view queries, reasons and missing value codes for that field. For more information on queries, reasons, and missing value codes, see Chapter 3, Metadata.

  • Focus Indicator. A colored bar indicates that the field is in focus, and the color indicates the status of the field. To learn more, see Focus Indicators.

  • Units. If units are defined for the field, they are shown in or near the input area. Where they are displayed depends on the type of input.

  • Warning Message. Warning messages appear when issues like illegal field values, missing values, or incorrectly formatted information are present in the field. Correct the issue to remove the message.

1.4.2. Responsive Elements

DFweb tries to adapt the content to fit displays of different sizes. Largely this is done by adjusting the spacing on the page, however greater changes are made when the display becomes too small. Some of the more significant changes are detailed here.

1.4.2.1. Sidebar Visibility

To allow more room for data entry, the sidebar is hidden on small displays. When it is hidden, a new button with the subject's status icon is added beside the CRF label. Clicking this button hides the data entry panel and shows the sidebar. Clicking the same button again hides the sidebar and shows the data entry panel.

1.4.2.2. Field Arrangment

On small displays, the organization of the fields also changes. The input area, date picker, units, reset button, and warning message are moved below the rest of the elements of the field, allowing enough room for all elements to be visible and useable.

1.4.3. Menus

1.4.3.1. Application Menu

The application menu provides functionality that is applicable for the entire study or user session. The following options are available:

  • Select Study. Select Select Study to navigate you back to the study list page. This option is only avaiable when you have selected a study and have permission for more than one study.

  • Copy URL. Select Copy URL to copy the URL of the current page to your device's clipboard. This allows you to easily share the URL with other users, and if they have permission to view the page, they are taken directly there after logging in.

  • Change Password. Select Change Password to open the Change Password dialog. This allows you to update your password.

  • Build History. Select Build History to open a new tab with the build history for DFweb. This allows you to review recent and past changes to DFweb and learn about any new features.

  • Logout. Select Logout to exit out of DFweb and return to the login page. Remember to always Logout after completing your work.

1.4.3.2. CRF Menu

The CRF Menu is only visible on the Subject Binder page. It provides actions for the entire CRF. A file icon on the menu indicates that this CRF has documents attached. A loading spinner on the menu button indicates that the CRF documents are still loading. The following actions are available:

  • Manage Documents. Select Manage Documents to open the Manage Documents dialog. This allows you to add or view documents for the current CRF. A number to the right shows the number of documents on this CRF.

  • Reset Page. Select Reset Page to reload the current CRF, resetting all fields and other elements to the last saved value. If you have made changes since your last save, you are warned that continuing with the reset removes unsaved changes.

1.4.4. Dialogs

1.4.4.1. Alert Dialogs

Alert dialogs provide warnings of different events or states in DFweb. Information in alert dialogs is important, and you should read them carefully before closing them. Example alert dialogs include:

  • Error Dialogs. Error dialogs warn you of errors in DFweb. These could be caused by a problem connecting to the DFdiscover server, or errors in DFweb's functionality. The text in the dialog provides details as to what happened. Depending on the error, DFweb may return you to another page, log you out, or leave you on the current page.

  • Session Timeout Dialog. If you have been away from DFweb for too long, DFweb logs you out. When this happens, a session timeout dialog is displayed.

  • Missing Permission Dialog. Some actions, such as trying to directly navigate to a CRF using a URL, can result in a missing permission dialog if you do not have permission to view the study, site, subject, etc. Close this dialog to return to the closest level in the navigation that you have permission to access.

  • Data Was Modified Dialog. Some illegal values cannot be accepted by the DFdiscover server. If you save a CRF with such values, they are altered by the server, and you are notified by this dialog. After closing this dialog, this information can be found by clicking next to the modified fields.

1.4.4.2. Confirmation Dialogs

DFweb displays confirmation dialogs to warn you of the (potentially unintended) consequences of an action you are about to perform and to give you a chance to cancel the action. Some confirmation dialogs are:

  • Unsaved Changes Dialog. Resetting or navigating away from a CRF that has unsaved changes on it triggers an unsaved changes dialog. This dialog gives you a chance to stop the action and save those changes before continuing.

  • Save Plate Confirmation Dialog. If you have entered values that cannot be saved as is by the DFdiscover server, when you save, DFweb warns you that these values may be modified, and give you a chance to go back to correct the values before saving.

  • Auto Logout Warning Dialog. If you have been inactive in DFweb for an extended period of time, this dialog is shown with a countdown to the logout, allowing you to choose to continue your session before the countdown reaches zero.

1.4.4.3. Study Help Dialog

Click beside the study name to open a dialog showing the study help. The content is displayed in the main body of the help dialog. Click to close the dialog.

1.4.4.4. CRF Help Dialog

The CRF help dialog is displayed when the user clicks beside the CRF label. Similar to the study help dialog, the CRF help dialog displays help content in the main section of the dialog, in this case, specific to the current CRF. The dialog is closed by clicking .

1.4.4.5. Modified Values Dialog

On occasion, a change in the study setup can cause a value to be saved to the study database that cannot be displayed in the field. In these cases, DFweb modifies the values as best as possible to make them fit in the field. You are notified of these modifications with this dialog when you open the CRF.

The dialog shows you a list of all fields modified in this way. For each field, the dialog shows you the field label, a message explaining why the value was modified, the value in the database, and what the value is after the modification.

Leaving the CRF without saving causes the modifications to be discarded and the database values to be preserved.

1.4.4.6. Attach Documents Dialog

The Attach Documents dialog provides a way to view and add documents to the CRF, and to download attached documents to your device. Documents are displayed in a list, and at the bottom of the list is an area for attaching a new document.

Each document in the list is displayed as a row with the document name, the size of the document, an expand document button (), and a download button (). Click displays the document in the dialog. Some document types cannot be displayed by the browser, so a message is shown in place of the document. Click to download the document to your device. This is especially useful for documents that can't be viewed in the browser as it allows you to open the document with a program designed to open files of that type.

To attach a new document to the CRF, click Choose Files. This opens a file chooser dialog. Select the file you wish to upload, and confirm the selection to close the dialog. Click Upload to attach the document.

If the CRF has not been saved, attaching a document saves an empty version of the CRF with the status Pending and the document attached. Saving with the CRF save button is still required to save any changes you have made to field values.

[Note]Note

The label of Choose Files may differ in the browser you are using.

At the top right of the Attach Documents dialog is the Download All button (). This button downloads a zip file containing all the documents attached to the CRF. Click Cancel to close the dialog.

1.4.4.7. Change Password Dialog

The Change Password dialog is displayed when you select Change Password from the Application Menu, or when you login for the first time after being given a new password by the study administrator. The text of the dialog indicates minimum password requirements.

To change your password, enter a new password that matches the requirements in New Password. Then enter the same password again in Confirm Password. If the password does not meet the requirements, an error message is displayed in red below Confirm Password. When you have entered a password and no error messages show, click Change to send the new password to the server. If the change does not succeed you are notified by an error message. Click Cancel to close the dialog without changing your password.

1.4.4.8. Add Subject Dialog

The Add Subject dialog is displayed when you click from the subject list page. It permits you to create a new subject within the range of allowable IDs for the site.

To create a new subject, enter the desired subject ID in Enter Subject ID. Enter the same ID in Confirm Subject ID. When you have entered an ID in both input areas and no errors are displayed, click OK to create the subject. The subject binder page for the new subject is displayed. Click Cancel to close the dialog without creating a new subject.

1.4.4.9. Query Dialogs

The Query Dialogs allow you to create (), edit (), reply to () and delete () queries for a field. Separate dialogs are used for each function. For a study in which multiple queries are permitted, there is an additional Multiple Queries dialog to view and initiate actions once a query has been created for the field. Click Q to open the query dialogs for the field. For more details on query dialogs and their use, see Queries.

1.4.4.10. Reason Dialogs

The Reason Dialogs allow you to create, edit, and delete reasons for a field. Separate dialogs are used for each function. Click R on the field's row to open the reason dialog. For more details on the reason dialog and its use, see Add a Data Reason.

1.4.4.11. Missing Value Code Dialog

The Missing Value Code dialog allows you to set (or unset) a missing value code for the field. Click M to open the Missing Value Code dialog. For more details on missing value codes and their use, see Mark a Data Value as Missing.

1.4.4.12. Terminology

A glossary of frequently used terms is presented below.

Document

A document is a file that is, or will be, attached to a CRF. Documents can be images, PDFs, videos or other file types.

Field

A field is a single data value and optional related metadata, including queries, the reason for the data value, possibly a missing value code, and other descriptive information about the field, such as its label and help. On DFweb, fields are presented as rows in screens.

Final (Status)

Final is a record status. A record can have status Final if there are no missing required fields, no illegal values and no outstanding queries. DFweb decorates Final records with a green shaded rectangle (see also Incomplete and Pending).

Incomplete (Status)

Incomplete is a record status. A record can be saved with status Incomplete if it has one or more fields which are incomplete (required and missing) or illegal, or outstanding queries. DFweb marks Incomplete records with a red partially shaded rectangle (see also Final and Pending).

Missing Value Code

A missing value code is used to identify a field that is known and accepted as empty. A missing value code allows even a required field to be blank and for the CRF to still be saved as Final.

New (Status)

New is a record status. A new record is a placeholder for data that has been entered but not saved yet. It can be a useful reminder for records which are expected but are not yet entered/saved. DFweb marks new records by an empty grey square, circle, or subject icon without a rectangle.

Pending (Status)

Pending is a record status. During entering a new data, a record can be saved with status Pending to indicate that data entry is still in progress, it has been started, not yet finished and you plan to return to it shortly and do not move to higher levels until they are saved with status Final or Incomplete. Pending records are typically not visible to or reviewed by the study coordinating site until they progress to Incomplete or Final status. Pending records are also not generally reported in summary listings.

DFweb saves CRFs as Pending after a document has been added to a new CRF but no data entry has been done. DFweb marks pending records with an orange empty rectangle.

Plate, or CRF

Plate and CRF are terms used interchangeably to refer to a logical grouping of data fields, presented with a layout determined by the study sponsor, to fit on a single sheet of paper, or single webpage. Each CRF may stand alone, or CRFs may be grouped into multi-CRF forms. A collection of CRFs (or forms) constitute a visit, and a collection of visits constitute the subject binder, which holds all study data for an individual subject.

Query

A query is a question or comment about an individual data value. The study coordinating site may add a query to any data field to ask a question about the field, or request a correction or clarification. A query is metadata about the data value, or lack thereof, in the field, DFweb identifies query status by applying color to the field. A field with an outstanding query is blue. When a reply is provided to a query, or a reason is added to explain the field, the color is updated to orange, and when the field has been corrected, or the reply or reason have been approved, the color changes to green, provided there are no other outstanding queries on the field.

Reason

A reason is metadata used to explain the value in a data field. It is particularly useful as a way of explaining unusual values and thereby avoiding a data query from the study coordinating site. DFweb colors fields with a new reason orange and gives them a Pending status. If the coordinating site accepts the reason, the field color changes to green and the reason status changes to Accepted. If they do not accept the reason, the field color changes to blue and the reason status changes to Rejected. A reason can be modified, which starts the review process over again.

Save

None of the changes made to a CRF are saved to the study database until you click Save. If you leave the computer without saving your work, DFweb will time-out after a few minutes and any un-saved changes will be lost.

Screen

A screen is an optional grouping of fields on a CRF. On smaller displays, screens can be useful for grouping fields to ensure that they are seen together. DFweb indicates screens using a tab, and multiple screens in a CRF are stacked vertically.

Subject

A subject is an individual participating in a clinical study and for whom data is collected. Subjects are identified by subject ID (a unique numeric identifier), according to conventions established by the study coordinating site.

Subject Binder

A subject binder contains all of the required and optional data collection forms used to collect study data for an individual subject. Within DFweb, subject binders are displayed in a list by subject ID, with an associated icon that indicates whether the binder is empty or contains recorded data, and whether that data is currently Final, Incomplete or Pending.

Visit

A visit is a study timepoint at which one or more CRFs for a subject are completed, or a repeating log form such as an adverse event or concomitant medications. The duration of a subject's participation in a study is often marked by a baseline visit, several repeating visits, and a termination visit.

1.4.5. Locking

When you enter a subject binder and the CRF becomes visible, DFweb attempts to establish a lock on the CRF. If it succeeds, you gain the lock on the CRF and other DFdiscover apps won't be able to edit the CRF until it is unlocked. If someone else already has the lock, your attempt fails and you are shown the locked CRF in read-only mode.

A locked CRF is indicated by a beside the save button. When a CRF is locked, all data fields are in read-only mode, meaning no data can be entered, and no queries, reasons, or missing codes can be added to the field. Existing queries, reasons, and missing codes can still be viewed by clicking the appropriate button, however all input fields and actions other than cancel are disabled. The Manage Documents dialog is accessible for document review, however no new documents can be uploaded to a locked CRF. Finally, Save and Reset Page are disabled on a locked CRF.

Exiting a CRF, whether by navigating to another CRF, exiting the subject, or logging out, unlocks the CRF.

1.4.6. Session Timeout

To maintain security, the DFweb login session is automatically closed if there is no activity for 20 minutes. A warning, with countdown, is displayed one minute before the session is closed. Click Stay logged in to continue to use DFweb and reset the timer.

In the event of session timeout, the following actions take place:

  • an information dialog is presented to notify that automatic logout has occurred

  • unsaved changes for the current CRF, if any, are discarded

  • the lock for the current CRF, if any, is released

  • you are logged out and taken back to the login screen

Never rely upon the session timeout to terminate a session. Always save changes to the current CRF and logout.

Chapter 2. Data Entry

2.1. Selecting a Subject

On the Subjects page, click a subject ID from the list to open the subject binder.

If the subject ID you need is not in the list, click to add a new subject. This opens a dialog with two text input fields. Enter the subject ID to add to the current site. Confirm the subject ID by entering it again. Click OK to confirm the subject creation, or Cancel to close the dialog without creating a subject.

2.2. Navigating the Subject Binder

Select a subject ID to open the first available visit and CRF for that subject. The sidebar displays the list of all available visits for that subject. Under each visit are the CRFs available at that visit. Click a visit to see the list of CRFs in the sidebar, and the first CRF for that visit opens. To begin data entry, select the appropriate visit and CRF.

2.3. Entering Data / Completing a Record

2.3.1. Data Entry Aids

2.3.1.1. Keyboard Navigation

Navigating from field to field is possible using the Tab key. The Save button, if enabled, is tabbed to after the last field. Within choice fields (shown as either radio buttons or dropdowns), the up and down arrow keys can be used to switch between options, and the option can then be selected using the Space key. Within visual analog scale (VAS) fields, the left and right arrow keys can be used to select a point on the scale.

2.3.1.2. Focus Indicators

The last in-focused field displays a vertical bar on the left edge of the field. It may have color information, including red (required and missing or illegal values), blue (outstanding query), green (resolved), orange (pending), and black (otherwise). The current active field is outlined; the highlight color matches the vertical bar, except in the case of a black vertical bar, in which case the highlight color is the default one for the browser.

2.3.1.3. Formatting

Some fields only accept specific data formats. Field formatting is shown in the blank field to help guide data entry. For example, a date field may have the format YYYY/MM/DD or a lab result field may have the format nn.nn.

2.3.1.4. Legal Ranges

Some fields may have legal ranges defined. If you enter an illegal value, you are shown a warning similar to: "The input value is not a legal value. The legal values are 01-JAN-2018~today." Correcting the value removes the warning and avoids queries.

2.3.1.5. Help

In addition to the description for each field on the CRF, Help information may be available for each field. This is indicated with a icon to the left of the input field. Click to view the Help message.

2.3.1.6. Field Skipping

When navigating fields on a CRF using the Tab key, some fields may be skipped. This indicates that the field skipped is not required and can remain blank.

2.3.1.7. Screens

Some CRFs may be divided into multiple screens. A screen has a main body for data as well as a clickable tab to control visibility. In the tab, click the arrow to collapse the fields within that screen, and click again to expand. By default, all screens are expanded when you open a CRF. The tab with the input focus cannot be closed.

2.3.2. Data Types

2.3.2.1. Number

Numeric digits (0-9), decimal (.), and a sign symbol (+ or -) can be entered in number fields. If a decimal or other character is required, it can be typed directly. Otherwise, it is entered automatically to match the required format for the field.

2.3.2.2. String

Any text may be entered in a string field. A maximum field length may be defined which limits the number of characters that can be entered.

2.3.2.3. Date

Use the date picker to select a date. The date picker can be scrolled using the scroll wheel on the mouse, or it can be navigated using the arrows keys. If a date is entered using the keyboard, it must follow the defined format, e.g. DD-MMM-YYYY, YYYY/MM/DD, DDMMYY. Partial dates may only be entered via the keyboard.

2.3.2.4. Time

Enter the time using hours, minutes, and seconds as indicated in the field format.

2.3.2.5. Choice

Only one response option can be selected for each choice field. The field is displayed as radio buttons if there are three or fewer response options, otherwise they are displayed in a drop-down menu. To remove a response, click Reset below the field.

2.3.2.6. Check

A check field can be checked or unchecked. Multiple check fields may be included in one item; check all that apply.

2.3.2.7. Visual Analog Scale (VAS)

Select a point along the scale using the cursor or the left and right arrow keys on the keyboard. The selected value is shown under the scale in the middle, with the first and last options in the scale shown on the left and right respectively. To remove a response, click Reset below the field.

2.3.3. Saving Data

When you have completed data entry on a CRF, you must save your changes before leaving the CRF. To do so, click Save, located near the right side of the header area.

If you leave the CRF before saving, the following dialog is presented:

Select Stay on page to remain on the CRF and save your changes. Select Leave Page to discard the data on the CRF. Your changes are not saved and cannot be retrieved.

2.3.4. Reset Page

Select Reset Page from the CRF menu to undo all unsaved changes and reset the CRF to the last saved database values. This can be useful if you are interrupted during data entry and lose track of where changes have been made. After confirmation, unsaved changes to data, queries and reasons are discarded.

2.4. Finding Subject Records

To return to the Subjects list from a subject binder, click the site number in the breadcrumb.

The Subjects list displays up to 50 subjects at a time. Click Show More to display additional subjects. To search for a specific subject ID, use the Search Bar.

Chapter 3. Metadata

3.1. Queries

Queries are used to request corrections or clarifications about the data. There are four query dialogs: Add Query, Edit Query, Reply to Query, and Delete Query. The following sections explain in detail how to use these dialogs.

For studies where multiple queries per field are enabled, there is an additional dialog where users can add a new query or choose an existing query to reply to, edit, or delete. Further details are provided in Multiple Queries Dialog.

3.1.1. Add Query

To add a query to a field, click Q. If there is no query on a field, the Add Query dialog opens. Select an appropriate category from the dropdown menu, and provide the query detail in the provided text field. Once complete, click Apply to add a query to the field.

3.1.2. Edit Query

To edit a query, click Q. If the query is resolved, the Edit Query dialog open. Otherwise, the Reply to Query dialog opens. Click Edit, and the Edit Query dialog opens. Select an appropriate category and status from the dropdown menu, and provide the query detail in the provided text field. Once complete, click Apply to finish editing the query.

3.1.3. Reply to Query

If a query is already resolved, it cannot be replied to. Otherwise, to reply to an outstanding query on a field, click Q. The Reply to Query dialog opens, displaying the query detail. Enter the query reply content in the provided text field. Once complete, click Apply.

3.1.4. Delete Query

Queries are rarely deleted. Once a query is created, it should be resolved, perhaps as irrelevant.

If it is necessary to delete an existing query, click Q. If the query is outstanding or pending, the Reply to Query dialog opens. Click Edit, and the Edit Query dialog opens. Click Delete, the Delete Query dialog opens. In the Delete Query dialog, click Delete to finish deleting the query on the field. At each step please ensure that the query really should be deleted.

3.1.5. Multiple Queries Dialog

In a study with multiple queries per field enabled, click Q for a field with an existing query to see the following multiple queries dialog:

The icons used in the multiple queries dialog are:

  • Reply

  • Edit

  • Delete

  • Add

Additionally, there is another difference between single and multiple query-enabled study query dialogs. In single query-enabled studies there are navigation buttons at the bottom of the dialogs to get from one dialog to another. These aren’t present on multiple query-enabled study query dialogs. Instead, the multiple query-enabled study query dialogs have a back arrow at the left top corner. The back arrow returns you to the Multiple Queries dialog.

3.2. Add a Data Reason

Reasons are a way to provide additional information about existing data or to explain why data is changed. For each data field, the user can add a new reason or edit an existing reason using the Reason for Data Value dialog.

To add a reason to a field, click R next to the field. The Reason for Data Value dialog opens. Select an appropriate status from the dropdown menu and enter reason detail in the provided text field. Click Apply to add the reason to the field.

In some cases, the Reason for Data Value dialog may open automatically when a data value is changed. In these cases, a reason is required before the data change is accepted. If the data change was made in error, click Revert to Old in the Add Reason dialog to discard the data change.

To edit an existing reason, click R to open the Reason for Data Value dialog. Change the reason status and/or detail and click Apply to finish editing and close the dialog.

To delete an existing reason, click R to open the Reason for Data Value dialog. Click Delete and then click Confirm Delete to confirm that the reason should be deleted.

3.3. Mark a Data Value as Missing

Missing value codes provide a way to mark a data value as missing. Users may select a missing value code for any data field that is not essential to indicate that the data value will not be entered.

To mark a data value as missing, click M next to the input field. The Missing Value dialog opens. Select an approriate missing value code from the dropdown menu, and click Apply to finish.

After marking a data value as missing, the field value is set to the missing value code and the field is disabled. Disabled fields can still be tabbed to, however editing the field is not possible.

To enter data in a field that has been marked as missing, click M next to it. In the Missing Value dialog, select the No code (reset) option from the dropdown menu, and click Apply to finish. This enables the field for data entry and resets the field value to blank.

3.4. Resolving Queries

Queries can be resolved via Q on the field.

Click Q, and then click Edit for the query that is to be resolved. Select an appropriate Status from the dropdown menu, and add Detail and Note in the provided text areas as needed. Once complete, click Apply to resolve the query.

3.5. Managing Documents

DFweb allows users to attach documents to a plate, which accommodates adding more data and information in other formats.

3.5.1. Supported Document Types

DFweb allows user to upload, view and download PDFs, images, audio, and video. Specifically for images, DFweb supports JPG, JPEG, PNG, BMP, DICOM, DIC, and DCM format; for audio, DFweb supports MP3, and WAV format; for video, DFweb supports MP4, and AVI format.

3.5.2. Reviewing Documents

Navigate to the Manage Documents dialog to review documents. This is available via the Manage Documents menu item under the CRF Menu (without documents) or (with documents), in the top right corner of the plate. Click to choose from the dropdown menu items:

The number next to Manage Documents indicates the number of existing documents for this plate. Click Manage Documents to open the Manage Documents dialog. Below is an example of the Manage Documents dialog.

In the Manage Documents dialog, users can review documents. To review a document, click to expand the collapsible content:

Click to collapse the content.

Many document types can be previewed or played without downloading first, including PDF, JPG, JPEG, PNG, BMP, MP3, WAV, and MP4 format. For DICOM, DIC, DCM, AVI or other formats, they must be downloaded first.

3.5.3. Adding Documents

Navigate to the Manage Documents dialog by following the instructions in Reviewing Documents.

Click Choose Files to open the file browser and select one or more files from your computer. Once complete, click Upload to add the file(s).

3.5.4. Downloading Documents

Navigate to Manage Documents dialog by following the instructions in Reviewing Documents.

Click to the right of the file name to download that particular file. Click the large at the top of the dialog next to the Manage Documents title to download in a zip file all the documents listed.

3.6. Sharing Links

The ability to share links minimizes the time and effort to navigate to a particular page.

Click the Application Menu, , and then select Copy URL from the dropdown menu. The copied URL can be re-visited at a future time, or shared with others.

When using a copied URL, the user is redirected to the login page first, where they are required to login. After successful login, the user is taken to the linked page.

Appendix A. Copyrights - Acknowledgments

A.1. External Software Copyrights

DFdiscover software uses several third-party software components as part of its server side and/or client tools.

The copyright information for each is provided below. If you would like to receive source codes of these third-party components, please send us your request at .

A.1.1. DCMTK software package

Copyright Copyright © 1994-2011, OFFIS e.V. All rights reserved.

This software and supporting documentation were developed by

OFFIS e.V.
      R&D Division Health
      Eschereg 2
      26121 OldenburgGermany

Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:

  • Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer.

  • Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution.

  • Neither the name of OFFIS nor the names of its contributors may be used to endorse or promote products derived from this software without specific prior written permission.

THIS SOFTWARE IS PROVIDED BY THE COPYRIGHT HOLDERS AND CONTRIBUTORS AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE COPYRIGHT HOLDER OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.

A.1.2. Jansson License

Copyright Copyright © 2009-2014 Petri Lehtinen <petri&digip.org>

Permission is hereby granted, free of charge, to any person obtaining a copy of this software and associated documentation files (the Software), to deal in the Software without restriction, including without limitation the rights to use, copy, modify, merge, publish, distribute, sublicense, and/or sell copies of the Software, and to permit persons to whom the Software is furnished to do so, subject to the following conditions:

The above copyright notice and this permission notice shall be included in all copies or substantial portions of the Software.

THE SOFTWARE IS PROVIDED AS IS, WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM, OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE SOFTWARE.

A.1.3. HylaFAX Facsimile Software

Copyright Copyright © 1990-1996 Sam Leffler Copyright Copyright © 1991-1996 Silicon Graphics, Inc. HylaFAX is a trademark of Silicon Graphics, Inc.

Permission to use, copy, modify, distribute, and sell this software and its documentation for any purpose is hereby granted without fee, provided that (i) the above copyright notices and this permission notice appear in all copies of the software and related documentation, and (ii) the names of Sam Leffler and Silicon Graphics may not be used in any advertising or publicity relating to the software without the specific, prior written permission of Sam Leffler and Silicon Graphics.

THE SOFTWARE IS PROVIDED AS-IS AND WITHOUT WARRANTY OF ANY KIND, EXPRESS, IMPLIED OR OTHERWISE, INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT SHALL SAM LEFFLER OR SILICON GRAPHICS BE LIABLE FOR ANY SPECIAL, INCIDENTAL, INDIRECT OR CONSEQUENTIAL DAMAGES OF ANY KIND, OR ANY DAMAGES WHATSOEVER RESULTING FROM LOSS OF USE, DATA OR PROFITS, WHETHER OR NOT ADVISED OF THE POSSIBILITY OF DAMAGE, AND ON ANY THEORY OF LIABILITY, ARISING OUT OF OR IN CONNECTION WITH THE USE OR PERFORMANCE OF THIS SOFTWARE.

A.1.4. Mimencode

Copyright Copyright © 1991 Bell Communications Research, Inc. (Bellcore)

Permission to use, copy, modify, and distribute this material for any purpose and without fee is hereby granted, provided that the above copyright notice and this permission notice appear in all copies, and that the name of Bellcore not be used in advertising or publicity pertaining to this material without the specific, prior written permission of an authorized representative of Bellcore. BELLCORE MAKES NO REPRESENTATIONS ABOUT THE ACCURACY OR SUITABILITY OF THIS MATERIAL FOR ANY PURPOSE. IT IS PROVIDED AS IS, WITHOUT ANY EXPRESS OR IMPLIED WARRANTIES.

A.1.5. RSA Data Security, Inc., MD5 message-digest algorithm

Copyright Copyright © 1991-2, RSA Data Security, Inc. Created 1991. All rights reserved. License to copy and use this software is granted provided that it is identified as the RSA Data Security, Inc. MD5 Message-Digest Algorithm in all material mentioning or referencing this software or this function. License is also granted to make and use derivative works provided that such works are identified as derived from the RSA Data Security, Inc. MD5 Message-Digest Algorithm in all material mentioning or referencing the derived work. RSA Data Security, Inc. makes no representations concerning either the merchantability of this software or the suitability of this software for any particular purpose. It is provided as is without express or implied warranty of any kind. These notices must be retained in any copies of any part of this documentation and/or software.

A.1.6. mpack/munpack

Copyright © Copyright 1993,1994 by Carnegie Mellon University All Rights Reserved.

Permission to use, copy, modify, distribute, and sell this software and its documentation for any purpose is hereby granted without fee, provided that the above copyright notice appear in all copies and that both that copyright notice and this permission notice appear in supporting documentation, and that the name of Carnegie Mellon University not be used in advertising or publicity pertaining to distribution of the software without specific, written prior permission. Carnegie Mellon University makes no representations about the suitability of this software for any purpose. It is provided as is without express or implied warranty.

CARNEGIE MELLON UNIVERSITY DISCLAIMS ALL WARRANTIES WITH REGARD TO THIS SOFTWARE, INCLUDING ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS, IN NO EVENT SHALL CARNEGIE MELLON UNIVERSITY BE LIABLE FOR ANY SPECIAL, INDIRECT OR CONSEQUENTIAL DAMAGES OR ANY DAMAGES WHATSOEVER RESULTING FROM LOSS OF USE, DATA OR PROFITS, WHETHER IN AN ACTION OF CONTRACT, NEGLIGENCE OR OTHER TORTIOUS ACTION, ARISING OUT OF OR IN CONNECTION WITH THE USE OR PERFORMANCE OF THIS SOFTWARE.

A.1.7. TIFF

Copyright Copyright © 1988-1997 Sam Leffler Copyright Copyright © 1991-1997 Silicon Graphics, Inc.

Permission to use, copy, modify, distribute, and sell this software and its documentation for any purpose is hereby granted without fee, provided that (i) the above copyright notices and this permission notice appear in all copies of the software and related documentation, and (ii) the names of Sam Leffler and Silicon Graphics may not be used in any advertising or publicity relating to the software without the specific, prior written permission of Sam Leffler and Silicon Graphics.

THE SOFTWARE IS PROVIDED AS-IS AND WITHOUT WARRANTY OF ANY KIND, EXPRESS, IMPLIED OR OTHERWISE, INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT SHALL SAM LEFFLER OR SILICON GRAPHICS BE LIABLE FOR ANY SPECIAL, INCIDENTAL, INDIRECT OR CONSEQUENTIAL DAMAGES OF ANY KIND, OR ANY DAMAGES WHATSOEVER RESULTING FROM LOSS OF USE, DATA OR PROFITS, WHETHER OR NOT ADVISED OF THE POSSIBILITY OF DAMAGE, AND ON ANY THEORY OF LIABILITY, ARISING OUT OF OR IN CONNECTION WITH THE USE OR PERFORMANCE OF THIS SOFTWARE.

A.1.8. PostgreSQL

Copyright © 1996-2014 by the PostgreSQL Global Development Group and is distributed under the terms of the license of the University of California below.

Postgres95 is Copyright © 1994-5 by the Regents of the University of California.

Permission to use, copy, modify, and distribute this software and its documentation for any purpose, without fee, and without a written agreement is hereby granted, provided that the above copyright notice and this paragraph and the following two paragraphs appear in all copies.

IN NO EVENT SHALL THE UNIVERSITY OF CALIFORNIA BE LIABLE TO ANY PARTY FOR DIRECT, INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, INCLUDING LOST PROFITS, ARISING OUT OF THE USE OF THIS SOFTWARE AND ITS DOCUMENTATION, EVEN IF THE UNIVERSITY OF CALIFORNIA HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE. THE UNIVERSITY OF CALIFORNIA SPECIFICALLY DISCLAIMS ANY WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. THE SOFTWARE PROVIDED HEREUNDER IS ON AN AS-IS BASIS, AND THE UNIVERSITY OF CALIFORNIA HAS NO OBLIGATIONS TO PROVIDE MAINTENANCE, SUPPORT, UPDATES, ENHANCEMENTS, OR MODIFICATIONS.

A.1.9. OpenSSL License

Copyright Copyright © 1998-2016 The OpenSSL Project. All rights reserved.

Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:

  1. Redistributions of source code must retain the above copyright notice, this list of conditions and the following disclaimer.

  2. Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution.

  3. All advertising materials mentioning features or use of this software must display the following acknowledgment: This product includes software developed by the OpenSSL Project for use in .the OpenSSL Toolkit. (http://www.openssl.org/)

  4. The names OpenSSL Toolkit and "OpenSSL Project" must not be used to endorse or promote products derived from this software without prior written permission. For written permission, please contact openssl-core@openssl.org.

  5. Products derived from this software may not be called OpenSSL nor may OpenSSL appear in their names without prior written permission of the OpenSSL Project.

  6. Redistributions of any form whatsoever must retain the following acknowledgment: This product includes software developed by the OpenSSL Project for use in the OpenSSL Toolkit. (http://www.openssl.org)

THIS SOFTWARE IS PROVIDED BY THE OpenSSL PROJECT AS IS AND ANY EXPRESSED OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE OpenSSL PROJECT OR ITS CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.

This product includes cryptographic software written by Eric Young (). This product includes software written by Tim Hudson ().

A.1.10. Original SSLeay License

Copyright Copyright © 1995-1998 Eric Young () All rights reserved.

This package is an SSL implementation written by Eric Young (). The implementation was written so as to conform with Netscapes SSL.

This library is free for commercial and non-commercial use as long as the following conditions are aheared to. The following conditions apply to all code found in this distribution, be it the RC4, RSA, lhash, DES, etc., code; not just the SSL code. The SSL documentation included with this distribution is covered by the same copyright terms except that the holder is Tim Hudson ().

Copyright remains Eric Young's, and as such any Copyright notices in the code are not to be removed. If this package is used in a product, Eric Young should be given attribution as the author of the parts of the library used. This can be in the form of a textual message at program startup or in documentation (online or textual) provided with the package.

Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met:

  1. Redistributions of source code must retain the copyright notice, this list of conditions and the following disclaimer.

  2. Redistributions in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution.

  3. All advertising materials mentioning features or use of this software must display the following acknowledgement: This product includes cryptographic software written by Eric Young () The word cryptographic can be left out if the rouines from the library being used are not cryptographic related :-).

  4. If you include any Windows specific code (or a derivative thereof) from the apps directory (application code) you must include an acknowledgement: This product includes software written by Tim Hudson ()

THIS SOFTWARE IS PROVIDED BY ERIC YOUNG AS IS AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE AUTHOR OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.

The licence and distribution terms for any publically available version or derivative of this code cannot be changed. i.e. this code cannot simply be copied and put under another distribution licence [including the GNU Public Licence.]

A.1.11. gawk

GNU GENERAL PUBLIC LICENSE Version 2, June 1991

http://www.gnu.org/licenses/gpl-2.0.html

Copyright Copyright © 1989, 1991 Free Software Foundation, Inc.


        51 Franklin Street, Fifth Floor
        BostonMA  02110-1301USA

Everyone is permitted to copy and distribute verbatim copies of this license document, but changing it is not allowed.

The licenses for most software are designed to take away your freedom to share and change it. By contrast, the GNU General Public License is intended to guarantee your freedom to share and change free software--to make sure the software is free for all its users. This General Public License applies to most of the Free Software Foundation's software and to any other program whose authors commit to using it. (Some other Free Software Foundation software is covered by the GNU Lesser General Public License instead.) You can apply it to your programs, too.

When we speak of free software, we are referring to freedom, not price. Our General Public Licenses are designed to make sure that you have the freedom to distribute copies of free software (and charge for this service if you wish), that you receive source code or can get it if you want it, that you can change the software or use pieces of it in new free programs; and that you know you can do these things.

To protect your rights, we need to make restrictions that forbid anyone to deny you these rights or to ask you to surrender the rights. These restrictions translate to certain responsibilities for you if you distribute copies of the software, or if you modify it.

For example, if you distribute copies of such a program, whether gratis or for a fee, you must give the recipients all the rights that you have. You must make sure that they, too, receive or can get the source code. And you must show them these terms so they know their rights.

We protect your rights with two steps: (1) copyright the software, and (2) offer you this license which gives you legal permission to copy, distribute and/or modify the software.

Also, for each author's protection and ours, we want to make certain that everyone understands that there is no warranty for this free software. If the software is modified by someone else and passed on, we want its recipients to know that what they have is not the original, so that any problems introduced by others will not reflect on the original authors' reputations.

Finally, any free program is threatened constantly by software patents. We wish to avoid the danger that redistributors of a free program will individually obtain patent licenses, in effect making the program proprietary. To prevent this, we have made it clear that any patent must be licensed for everyone's free use or not licensed at all.

The precise terms and conditions for copying, distribution and modification follow.

TERMS AND CONDITIONS FOR COPYING, DISTRIBUTION AND MODIFICATION

  1. This License applies to any program or other work which contains a notice placed by the copyright holder saying it may be distributed under the terms of this General Public License. The Program, below, refers to any such program or work, and a work based on the Program means either the Program or any derivative work under copyright law: that is to say, a work containing the Program or a portion of it, either verbatim or with modifications and/or translated into another language. (Hereinafter, translation is included without limitation in the term modification.) Each licensee is addressed as you.

    Activities other than copying, distribution and modification are not covered by this License; they are outside its scope. The act of running the Program is not restricted, and the output from the Program is covered only if its contents constitute a work based on the Program (independent of having been made by running the Program). Whether that is true depends on what the Program does.

  2. You may copy and distribute verbatim copies of the Program's source code as you receive it, in any medium, provided that you conspicuously and appropriately publish on each copy an appropriate copyright notice and disclaimer of warranty; keep intact all the notices that refer to this License and to the absence of any warranty; and give any other recipients of the Program a copy of this License along with the Program.

    You may charge a fee for the physical act of transferring a copy, and you may at your option offer warranty protection in exchange for a fee.

  3. You may modify your copy or copies of the Program or any portion of it, thus forming a work based on the Program, and copy and distribute such modifications or work under the terms of Section 1 above, provided that you also meet all of these conditions:

    1. You must cause the modified files to carry prominent notices stating that you changed the files and the date of any change.

    2. You must cause any work that you distribute or publish, that in whole or in part contains or is derived from the Program or any part thereof, to be licensed as a whole at no charge to all third parties under the terms of this License.

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      Thus, it is not the intent of this section to claim rights or contest your rights to work written entirely by you; rather, the intent is to exercise the right to control the distribution of derivative or collective works based on the Program.

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  12. BECAUSE THE PROGRAM IS LICENSED FREE OF CHARGE, THERE IS NO WARRANTY FOR THE PROGRAM, TO THE EXTENT PERMITTED BY APPLICABLE LAW. EXCEPT WHEN OTHERWISE STATED IN WRITING THE COPYRIGHT HOLDERS AND/OR OTHER PARTIES PROVIDE THE PROGRAM AS IS WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. THE ENTIRE RISK AS TO THE QUALITY AND PERFORMANCE OF THE PROGRAM IS WITH YOU. SHOULD THE PROGRAM PROVE DEFECTIVE, YOU ASSUME THE COST OF ALL NECESSARY SERVICING, REPAIR OR CORRECTION.

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A.1.12. Ghostscript

The files in the base, psi, lib, toolbin, examples, doc and man directories (folders) and any subdirectories (sub-folders) thereof are part of GPL Ghostscript.

The files in the Resource directory and any subdirectories thereof are also part of GPL Ghostscript, with the explicit exception of the files in the CMap subdirectory (except Identity-UTF16-H, which is part of GPL Ghostscript). The CMap files are copyright Adobe Systems Incorporated and covered by a separate, GPL compatible license.

The files under the jpegxr directory and any subdirectories thereof are distributed under a no cost, open source license granted by the ITU/ISO/IEC but it is not GPL compatible - see jpegxr/COPYRIGHT.txt for details.

GPL Ghostscript is free software; you can redistribute it and/or modify it under the terms the GNU General Public License as published by the Free Software Foundation, either version 3 of the License, or (at your option) any later version.

GPL Ghostscript is distributed in the hope that it will be useful, but WITHOUT ANY WARRANTY; without even the implied warranty of MERCHANTABILITY or FITNESS FOR A PARTICULAR PURPOSE. See the GNU General Public License for more details.

You should have received a copy of the GNU General Public License along with this program so you can know your rights and responsibilities. It should be in a file named doc/COPYING. If not, write to the


    Free Software Foundation, Inc., 59 Temple Place Suite 330BostonMA
    02111-1307USA.
    

GPL Ghostscript contains an implementation of techniques covered by US Patents 5,055,942 and 5,917,614, and corresponding international patents. These patents are licensed for use with GPL Ghostscript under the following grant:

Whereas, Raph Levien (hereinafter Inventor) has obtained patent protection for related technology (hereinafter Patented Technology), Inventor wishes to aid the the GNU free software project in achieving its goals, and Inventor also wishes to increase public awareness of Patented Technology, Inventor hereby grants a fully paid up, nonexclusive, royalty free license to practice the patents listed below (the Patents) if and only if practiced in conjunction with software distributed under the terms of any version of the GNU General Public License as published by the

Free Software Foundation, 59 Temple Place, Suite
        330
BostonMA 02111

Inventor reserves all other rights, including without limitation, licensing for software not distributed under the GNU General Public License.

5055942 Photographic image reproduction device using digital halftoning to para images allowing adjustable coarseness 5917614 Method and apparatus for error diffusion paraing of images with improved smoothness in highlight and shadow regions

A.1.13. MariaDB and FreeTDS

GNU LESSER GENERAL PUBLIC LICENSE Version 2.1, February 1999 http://www.gnu.org/licenses/lgpl-2.1.html

Copyright Copyright © 1991, 1999


    Free Software Foundation, Inc.
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Everyone is permitted to copy and distribute verbatim copies of this license document, but changing it is not allowed.

[This is the first released version of the Lesser GPL. It also counts as the successor of the GNU Library Public License, version 2, hence the version number 2.1.]

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A.1.14. QtAV

Copyright © Wang Bin Shanghai University->S3 Graphics->Deepin, Shanghai, China 2013-01-21

**QtAV is free software licensed under the term of LGPL v2.1. The player example is licensed under GPL v3. If you use QtAV or its constituent libraries, you must adhere to the terms of the license in question.**

Rather than repeating the text of the LGPL v2.1, the original text can be found in GNU LESSER GENERAL PUBLIC LICENSE, Version 2.1.

A.1.15. FFmpeg

Most files in FFmpeg are under the GNU Lesser General Public License version 2.1 or later (LGPL v2.1+). Read the file `COPYING.LGPLv2.1` for details. Some other files have MIT/X11/BSD-style licenses. In combination the LGPL v2.1+ applies to FFmpeg.

Rather than repeating the text of the LGPL v2.1, the original text can be found in GNU LESSER GENERAL PUBLIC LICENSE, Version 2.1.

A.1.16. c3.js

The MIT License (MIT) Copyright © 2013 Masayuki Tanaka

Permission is hereby granted, free of charge, to any person obtaining a copy of this software and associated documentation files (the "Software"), to deal in the Software without restriction, including without limitation the rights to use, copy, modify, merge, publish, distribute, sublicense, and/or sell copies of the Software, and to permit persons to whom the Software is furnished to do so, subject to the following conditions:

The above copyright notice and this permission notice shall be included in all copies or substantial portions of the Software.

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A.1.17. d3.js

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