SMART Submit 3.12 User Guide - mywebsend.com

1 SMART Submit Release user Guide Document Version SMART Submit user Guide 2018 Bioclinica Proprietary and confidential Page 2 of 43 Table of Contents TABLE OF 2 WELCOME TO SMART Submit .. 5 RELEASE UPDATES .. 5 GETTING ACCESS .. 6 WELCOME EMAIL .. 6 Logging In .. 6 Forgot Password .. 6 CHANGING YOUR PASSWORD .. 7 SELECT STUDY .. 7 8 USING SMART Submit .. 9 LINK MENU .. 9 MAIN MENU .. 9 SCREEN PANELS .. 9 ACTION ICONS .. 9 FILTERS .. 10 WORKING WITH FILTERS .. 10 EXPORT TO EXCEL .. 10 CONTACT INFORMATION .. 11 TO-DO LIST .. 12 THE LIST OF TASKS .. 12 Left Panel (Filters) .. 12 Center Panel: The List .. 12 Right Panel: 12 List Menu (Options vary based on the selected row.) .. 12 SUBJECTS .. 13 THE SUBJECT LIST .. 13 Left Panel (Filters) .. 13 Center Panel: The List .. 13 Right Panel: 13 List Menu (Options vary based on the selected row.)

2 13 ADD A SUBJECT .. 14 SUBJECT IMAGE LIST .. 15 Left Panel (Subject).. 15 Center Panel: The List .. 15 Right Panel: 15 List Menu (Options vary based on the selected row.) .. 15 VIEW EDTF .. 16 VIEW SEQUENCE .. 16 IMAGE GRID .. 17 THE IMAGE GRID TOOLBAR .. 18 QUERIES .. 19 Left Panel (Filters) .. 19 Center Panel: The List .. 19 Right Panel: 20 List Menu (Options vary based on the selected row.) .. 20 EXPORT QUERY .. 20 QUERY DETAILS .. 21 Left Panel (Subject).. 21 SMART Submit user Guide 2018 Bioclinica Proprietary and confidential Page 3 of 43 Center Panel: Query Information .. 21 List Menu (Options vary based on query status) .. 21 VIEW QUERIES .. 22 REPLY TO QUERIES .. 22 SURVEYS .. 23 THE SURVEY LIST .. 23 Left Panel (Filters) .. 23 Center Panel: The List .. 23 Right Panel: 23 List Menu (Options vary based on the selected row.) .. 23 SURVEY FORM.

3 24 Left Panel (Surveys).. 24 Center Panel: Survey Form .. 24 Right Panel (Questions) .. 24 List Menu (Options vary based on survey status) .. 24 VIEW A SURVEY .. 25 ANSWER A SURVEY .. 25 EXPORT BLANK PDF .. 25 DOCUMENTS .. 26 Left Panel (Filters) .. 26 Center Panel: The List .. 26 DOWNLOAD A DOCUMENT .. 26 HISTORY .. 27 Left Panel (Filters) .. 27 Center Panel: The History List .. 27 Right Panel: 27 List Menu (Options vary based on the selected row.) .. 28 SET PROCESSING STATUS .. 28 DOWNLOAD IMAGE .. 28 VIEW EDTF .. 29 ATTACHMENTS .. 30 DOWNLOAD ATTACHMENT .. 30 ADD ATTACHMENTS .. 31 TRAINING .. 32 FEATURED TRAINING .. 32 SMART Submit TRAINING .. 33 IMAGE UPLOAD .. 34 OVERVIEW .. 34 Two Methods of Starting Image Upload .. 34 SELECT PROTOCOL/SITE .. 34 SELECT SUBJECT/TIME POINT .. 35 Select an Existing Subject .. 35 Adding a Subject .. 35 SELECT FILES .. 36 CD/DVD 36 Select Directory.

4 36 Select Individual Files .. 37 File Types .. 37 UPLOADING MULTIPLE PATIENTS/MULTIPLE EXAM DATES .. 38 Selecting Patients/Exams to Upload .. 38 ADD ATTACHMENTS .. 38 DATA TRANSMITTAL FORM (EDTF) .. 39 SMART Submit user Guide 2018 Bioclinica Proprietary and confidential Page 4 of 43 MASK IMAGES .. 40 UPLOAD CONFIRMATION .. 41 UPLOAD STATUS .. 42 PARAMETERS .. 43 SETTING YOUR UPLOAD WORKING FOLDER .. 43 SETTING DEBUG MODE .. 43 SMART Submit user Guide 2018 Bioclinica Proprietary and confidential Page 5 of 43 Welcome to SMART Submit WebSend has been updated to be part of Bioclinica s SMART Services Suite and is now known as SMART Submit . As a result, there have been changes to the look and feel but no change in functionality. SMART Submit is Bioclinica's web-based system for clinical trial image uploads and related communication management. Clinical sites use SMART Submit to upload images along with completed electronic Data Transfer Forms and access and reply to queries.

5 The image upload interface guides the user through a series of steps designed to ensure that images conform to requirements before they are transferred. The user can mask protected information on the images, and the system automatically conducts a preliminary QC check. In addition to the standard SMART Submit images upload, the users can also use AG Mednet or a new SMART Submit upload client, per trial configuration. For more information on AG Mednet see: FAQ Quick Reference user Manual To know more about the new SMART Submit upload client see: SMART Submit Research Site Introduction Release Updates A new reply type TAT Track has been added to the eDTF questions. When configured for the project, the SMART Submit (WebSend) users will be asked to select the appropriate TAT track from the provided list for the current submission. SMART Submit user Guide 2018 Bioclinica Proprietary and confidential Page 6 of 43 Getting Access Welcome Email Bioclinica sends each new SMART Submit user a "Welcome" email with their user id and password.

6 This welcome email contains everything you need to get started. You can download our training schedule, a PDF version of the user Guide and the quick start Guide . If you've been expecting this information and it is not available to you, contact Bioclinica's help desk: US and Canada: 1-888-ASK-BIO2 (1-888-275-2462) International: +1-484-928-6076 Email: Logging In Once you have received the welcome email, you will be able to log into SMART Submit and change your default password. 1. Enter your email and password from the Welcome email. 2. Click Sign In. If this is the first time that you are logging on, the Change Password box automatically displays. If you have already changed your password, the Select a Study page displays. Forgot Password If you forget your password, click the Forgot Password on the login page, enter your email address and click Send.

7 SMART Submit user Guide 2018 Bioclinica Proprietary and confidential Page 7 of 43 Changing Your Password To ensure that your password is secure, you will be required to change your default password before you will be able to log in a second time. The Change Password screen automatically displays. 1. Enter your email and default password. 2. Enter a new password. The password must be at least 8 characters long and must contain at least three of the following: an upper-case letter, a lower-case letter, a number, and a symbol. 3. Re-enter the new password in the Confirm Password field. 4. Click Submit . If you have access to multiple studies, the Select Study page displays. If not, the TO-DO page displays. Select Study If you have access to more than one study, or multiple sites within a study, the System displays a study selection dialog after login: 1.

8 Click the study or study/site combination you wish to work with from the list. The TO-DO page displays. SMART Submit user Guide 2018 Bioclinica Proprietary and confidential Page 8 of 43 Logout To logout of SMART Submit , click Logout in the upper right corner of the screen. The system confirms that you have successfully logged out. SMART Submit user Guide 2018 Bioclinica Proprietary and confidential Page 9 of 43 Using SMART Submit Link Menu The link menu displays in the upper right corner of the SMART Submit screens. - Displays phone, fax and email information. - Displays online help. - Displays the new SMART Portal. Main Menu TO-DO list of tasks and processing options organized by date SUBJECTS list of tasks and processing options organized by subject QUERIES list of queries and processing options (Only open queries are listed by default, but there is an option to include closed queries.)

9 SURVEYS list of surveys and processing options (Only published surveys are listed by default, but there is an option to include All queries.) DOCUMENTS list of trial and site level documents uploaded by Bioclinica and available for you to download HISTORY - on-screen report that displays a list of SMART Submit uploads for trials for which you are authorized TRAINING provides access to the SmartStart training site IMAGE UPLOAD launches the File Transfer application in a separate browser tab Screen Panels 1. Left Panel: selections to narrow down what is shown in the center panel - See Working with Filters for more information. 2. Center Panel: List contains rows that can be selected for processing 3. Right Panel: displays data for selected row (first row selected by default Action Icons Action icons link to other pages for you to take a specific action.)

10 They display, where applicable, on list rows. They also display as buttons the bottom of any given list. The action buttons at the button may apply to the entire list (such as Export to Excel). SMART Submit user Guide 2018 Bioclinica Proprietary and confidential Page 10 of 43 Filters The Filters panel allows you to make selections to narrow down what is shown in the center panel. The parameters of the filters are depended on the columns and items that are displayed in the center panel. Working with Filters 1. Select the parameters that you wish to use to filter the contents of the center panel. 2. When you are finished, click . 3. To reset the filters at any time, click . Export to Excel The Export to Excel button is available on most of the pages in SMART Submit . This button allows you to export the displayed list to Excel. Export to Excel 1. Click from any page.