ERT Portal Helpfile · plethysmograph and ViaPen aspects of clinical trials. The Web Portal is a tool that enables the Monitors, Data Managers, and the Study Management ... for whom

ERT Portal Online Help

ERT Portal Online Help, v1.0 © 2015 eResearchTechnology GmbH. All Rights Reserved Page 1 of 25




Table of Contents 1. Purpose ................................................................................................................................................ 4

2. Disclamer on Terminology and Screenshots ................................................................................. 4

3. Sign-in Procedures ............................................................................................................................. 4

3.1 Web Portal Access Website ........................................................................................................... 4

3.2 Obtaining Username/Password ..................................................................................................... 4

3.2 Signing-in .......................................................................................................................................... 5

4. Sign-in Procedures ............................................................................................................................. 6

4.1 Navigation Menu .............................................................................................................................. 6

4.2 “Site View” Window Pane ............................................................................................................... 7

4.3 “Study” ............................................................................................................................................... 8

4.3.1 “Status” Tab ............................................................................................................................... 8

4.3.2 “Search” Tab ............................................................................................................................. 8

5 Reviewing Site Information .................................................................................................................... 9

5.1 “My Portal” – “Site” Submenu Option ........................................................................................... 9

5.1.1 “Site View” Window Pane........................................................................................................ 9

5.1.2 “Site Info” Window Pane........................................................................................................ 10

5.1.3 "Subject View" Window Pane ............................................................................................... 12

5.2 "My Portal" - "Site" - "Site Summary" Submenu Option .......................................................... 12

5.3 "My Portal" - "Site" - "QC Summary" Submenu Option ........................................................... 13

6. Reviewing Subject Data .................................................................................................................. 14

6.1 "My Portal" - "Site" - "Subject" Submenu Option ...................................................................... 14

6.1.1 "Overview" Tab ................................................................................................................. 15

6.1.2 "Subject Info" Tab ............................................................................................................. 15

6.1.3 "Subject Monitoring" Tab ....................................................................................................... 16

6.1.4 "Visit Details" Tab ................................................................................................................... 18

6.1.4.1 Spirometry ............................................................................................................................ 18

6.1.4.2 ECG ....................................................................................................................................... 20

6.1.4.3 VIAPen® ............................................................................................................................... 21

6.1.5 "Visit Calendar" Tab ............................................................................................................... 21

7. Reports .................................................................................................................................................. 22

7.1 Creating Reports ............................................................................................................................ 22



8. Documents – Downloading Proficiency Certificates ....................................................................... 24

9. About Us ................................................................................................................................................ 25



ERT Portal

1. Purpose

To improve accuracy, efficiency, and accelerate turnaround time for our clients, ERT has developed an innovative approach to managing the cardiac safety, spirometry, ios, diffusion, plethysmograph and ViaPen aspects of clinical trials. The Web Portal is a tool that enables the Monitors, Data Managers, and the Study Management to access clinical trial data collected from participating sites. This portal gives the user access to view the clinical trials data compiled per country, site, Subject, and visit. One of the important features of this web portal is that it also allows Study Management and Monitors to generate up-to-date reports, e.g. about data quality, enrollment status etc.

2. Disclamer on Terminology and Screenshots Depending on the user role (International Study Manager, Data Manager, Monitor/CRA, etc.), the ERT Portal provides different views and access to information. These views are optimized and compiled to assist in performing the duties of the user. Thus, each role has different access rights to specific sections on the Web Portal. The availability of the menus and behavior of each option in the Navigation Menu is dependent on the Web Portal user role. In addition, this portal is customized for each specific study using the terminologies specified in the study protocol. It should be noted that the terminologies used within the ERT Portal and the customized views might differ from what is shown on the screenshots in this document (e.g. Subject = patient; site = center).

3. Sign-in Procedures

3.1 Web Portal Access Website

The ERT Web Portal can be accessed by using the link

https://vcsportal.viasyscs.com/vcsportal

on your web browser. If you encounter any problems, please call the ERT help desk.

3.2 Obtaining Username/Password

https://vcsportal.viasyscs.com/vcsportal



At study start, the username along with the link to the ERT Web Portal will be mailed to the user‘s registered email address. The initial password will follow in a separate email.

3.2 Signing-in Enter the provided username and password and click on "sign-in".

When prompted, change the password so that the new password complies with the restrictions given in the dialog box.

Users involved in multiple studies will need to select the appropriate study from the drop-down list and click on the "sign-in" button to enter the Web Portal. However, those with access to a single study will directly be forwarded to the "My Portal" view.



4. Sign-in Procedures

After signing in, the top-level view "My Portal" - "Site" is displayed. This default window displays an overview of the information available on a specific study. At the top of the screen, the Information Header Bar gives the project name, current window (position), user name, and the "Log Out" option. The main screen space is split into four window panes: Navigation Menu, "Site View", "Study", and "Messages", as shown below.

4.1 Navigation Menu



On the left-side panel of the window, the Navigation Menu will always be available. To navigate to another section of the Web Portal, click on the menu options available within the Navigation Menu. These menu options allow the user to access compiled data, documents, messages, and reports. Note that depending on the user role, the navigation items might be different from the screenshot given above.

4.2 “Site View” Window Pane

The default "Site View" window pane lists the country names of the sites that are participating in the study. The columns provide overall status information such as: the total number of Subjects for whom data has been collected utilizing ERT devices, the number of Subjects who are enrolled, are randomized,have completed, or have prematurely withdrawn from the study. The QC Findings column is provided to help Monitors track the quality or usability of the data captures. A 100% under the QC Findings column indicates that there were QC findings in every measurement. The lower the percentage of QC findings, the better the quality of data.

The page number is given at the buttom of the window pane on the Page Selector. If the number of countries exceeds the window size, the user can click through the page numbers to view information listed on the following pages.



Using the navigation keys (for "Next"), (for "Last site on the very last page"),

(for "Previous") and (for "First site on the very first page"), the user can scroll through the listed country names. The ratio given between the navigation keys allows the user to keep track

the country that is currently selected among all those listed. For example, indicates that among the 22 countries in the list, the first one is highlighted and therefore selected.

4.3 “Study”

The "Study" window pane consists of two tabs - Status and Search - that provide pertinent information to a user who is looking for either top-level or Subject-level data from the clinical trial.

4.3.1 “Status” Tab

The "Status" tab is not available to all Web Portal users and allows Study Management to view up-to-date graphical/numerical displays the number of Subjects who are enrolled and/or randomized for the entire study.

4.3.2 “Search” Tab

The search window allows the user to search and filter by site or Subject information. For instance, a user can choose "Site" from the Search for drop-down list and search by Site #, Investigator name, and/or Country name.



In addition, the drop-down list allows searching for Subjects included in the study, in training mode, or in proficiency training mode. The search criteria in these cases are the ERT internal SYS # or the sponsor‘s Subject #, screening #, and/or randomization #.

5 Reviewing Site Information

5.1 “My Portal” – “Site” Submenu Option

5.1.1 “Site View” Window Pane

From the "My Portal" menu, the user may drill-down to obtain information about each site listed under a country. The list of sites in each country can be viewed by clicking on the country name from the "My Portal" window pane.



5.1.2 “Site Info” Window Pane

A user can obtain specific information regarding a site by reviewing the information on the "Site/Center Info" window pane. This pane is comprised of three detail tabs:

5.1.2.1 "Overview" Tab The"Overview" tab shows relevant information about the site, such as the site #, address, primary investigator name, date of first data transfer (if applicable), and date of last data transfer (if applicable).

5.1.2.2 "Contacts" Tab

The "Contacts" tab lists all contacts for the site, as well as their email addresses and phone numbers.





5.1.2.3 "Notes" Tab

Any notes associated with the site are provided in this tab.

5.1.3 "Subject View" Window Pane

In the "Subject View" window you see a list of all Subjects at the site who are in the study with their current status (e.g. enrolled, screened, randomized and completed). This list is up-to-date as of the last data transfer. The Subjects are sorted by Subject Number as a default, but they can be sorted by all other columns, too.

The navigation is the same as in the "Site" window with icons to go to the next or previous Subject. If there are more than 8 Subjects listed for the site, click on the next page number to view information about these Subjects.

5.2 "My Portal" - "Site" - "Site Summary" Submenu Option

This submenu provides a summary of the information available about the site. The displayed information depends on the study protocol.



5.3 "My Portal" - "Site" - "QC Summary" Submenu Option

The "QC Summary" submenu shows summary information about the quality of the data collected at the sites, as determined by the ERT OverReaders. This QC information is listed in separate columns for all modalities used in a specific study (e.g. Forced Spirometry, ECG, ...).



6. Reviewing Subject Data

6.1 "My Portal" - "Site" - "Subject" Submenu Option

To see additional details about a Subject, click on "Subject" under the "Site" submenu on the

Navigation Menu. The Web Portal view changes to a screen with visit-specific details about the

currently highlighted Subject.

An alternative way to reach a Subject‘s visit-specific window screen is to click on the "Subject

Number" in the "Subject View" window pane. The "Subject" screen has five tabs offering the

following information about the Subject: study data overview, Subject information, Subject

monitoring, visit details, and a visit calendar. On each of these tabs, Subject-specific

demographics information is given at the top of the screen.



6.1.1 "Overview" Tab

The Overview tab is the default view of the "Subject" submenu. It lists the visits the Subject has already completed (up to the last data transfer) and provides specific information about these visits.

6.1.2 "Subject Info" Tab

The "Subject Info" tab provides the user with specific information about the Subject identifiers

(that is SYS #, Subject Number etc...), demographics and vitals. If the Subject identifiers,

demographics and/or vitals have been changed, this window also shows a part of the audit log.



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6.1.3 "Subject Monitoring" Tab

The "Subject Monitoring" view shows by default the pulmonary data that was downloaded from the Ambulatory Monitor (AM), i.e. the PEF or FEV1 data, collected using the AM device. The individual attempts (PEF or FEV1) are seen as colored dots (red or blue). The user may click on each individual attempt in the data set to see the value associated with it or browse through the individual attempts by clicking on the arrow icons.

When viewing the pulmonary data, the drop-down box at the bottom left corner of the window allows the user to choose the set of data to be displayed. In addition, the user can click on the icons below "View Range" or enter a data range from which to view the data. The default "View Range" icons are: One Day, One Week, Two Weeks, One Month, Three Months, Six Months, Twelve Months, and All. Another view available for the user is the Questionnaire view. When this view is selected, answers to the morning and evening questionnaires (if applicable) are displayed. The individual answers to the morning questionnaire will be displayed in blue colored dots while the individual answers to the evening questionnaire in red colored dots.



The user can choose to see the morning, or the evening, or all answers to the questionnaires.

The icons may be used to collapse (left side) or expand (right side) all answers in the

questionnaire. To collapse an individual answer in the questionnaire, click on the following

icon. The icon expands an individual answer in the questionnaire. Both, pulmonary as well as questionnaire data can also be viewed in a List View. The answers or measurement values are listed by date per each row. To toggle between pulmonary and questionnaire data, select "Parameter" or "Answer", respectively from the drop-down menu box. The visit selection drop-down menu box is used to choose a visit, such that all available data between that visit and the previous visit is displayed.



6.1.4 "Visit Details" Tab

The "Visit Details" tab provides details about the measurements taken during each visit. The user can choose which visit to view using the Visit drop-down menu box. Depending on the protocol, the measurements obtained during each visit would vary and could include pre-/post- spirometry, pre-/post-ECG, and/or VIApen data. Click on the links in the upper left corner of the screen to view the measurement details.

6.1.4.1 Spirometry

The spirometry data view displays the flow-volume curves Original Trials, Before Best Test Review and After Best Test Review and all relevant parameter values of all attempts, as specified in the study protocol. In addition, any Operator Comments given after each test, Error Codes, QC Statements and Best Test Review Statements as provided by the OverRead experts are presented.





6.1.4.2 ECG The user can view ECG data that was captured during a visit by clicking on the ECG link. the ECG recording is provided along with its corresponding values, which are displayed in a table at the bottom of the screen. In addition, there are tabs for OverRead QC Statements, OverRead Signature as well as Operator Comments entered after the measurement.



6.1.4.3 VIAPen®

The user is able to view the data captured using a VIAPen® by clicking on the VIAPen® link within the "Subject - Visit Details" tab. All the pages of the questionnaire that were captured are available for review in this screen.

6.1.5 "Visit Calendar" Tab

The visit calendar shows the already performed visits for the selected Subject up to the last data transfer.



7. Reports In the report section, the users can generate up-to-date reports for many purposes. The reports show compiled data across a group of countries, sites or Subjects and therefore are useful to get an overview of the data. Upon completion, the report is sent to the user‘s registered email address. Each report that can be selected from the drop-down menu consists of several sub-reports. The reports can be generated by country, site and Subject and the format can be chosen between Portable Document Format (PDF) or MS Excel (XLS).

7.1 Creating Reports

Step 2: Select the format for the report. To be able to filter the data from the report (e.g. according to site, user, etc.), it is recommended to select "MS Excel (XLS)" as the preferred report format.



Step 3: Click on "Create to generate the selected reports.

A message appears stating that the requested report is being processed and will be sent to the user‘s email address shown in the message box.

The requested reports will be sent to the user via email as a zip attachment.



8. Documents – Downloading Proficiency Certificates The proficiency certificates can be downloaded here by the monitors or by study management. Please find below a description of how to download the certificates. Users who have successfully performed the proficiency test(s) and attended ERT training will receive a proficiency certificate - "Certificate of Achievement". Step 1. Click on "Documents" in the Navigation Menu.

Step 2. All proficiency certificates that were created for certified users thus far will be available here.

Step 3. Choose a certificate and click on "Download".



Step 4. The certificate will open in a separate window and can now be printed. In order to download the certificate, the pop-up blocker must be disabled.

9. About Us

The "About Us" section provides the ERT "Imprint" with service contacts and the ERT "Privacy Statement".