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Making Ontario a preferred location for Global Clinical Trials, while maintaining the highest ethical standards. CTO Stream (Applicant) - Getting Started 1. ABOUT CTO STREAM ............................................................................................................................ 2 1.1. Target Audience ........................................................................................................................... 2 1.2. How to Access the System ........................................................................................................... 2 1.3. Internet Settings ........................................................................................................................... 2 1.4. Technical Support ......................................................................................................................... 3 2. GETTING STARTED ................................................................................................................................ 3 2.1. CTO Stream Home Page ............................................................................................................... 3 2.2. How to Register a New Account .................................................................................................. 4 2.3. How to Log In................................................................................................................................ 5 3. NAVIGATING CTO STREAM .................................................................................................................. 5 3.1. Work Area..................................................................................................................................... 6 3.2. The Navigation Menu ................................................................................................................... 6 3.3. Contacts ........................................................................................................................................ 7 3.4. Actions Toolbar............................................................................................................................. 8 3.4.1. Create Project ....................................................................................................................... 8 3.4.2. Delete Project ....................................................................................................................... 9 3.4.3. Duplicate Project ................................................................................................................ 10 3.4.4. Transfer ............................................................................................................................... 11 3.5. General Menu ............................................................................................................................. 12 3.5.1. Notifications ....................................................................................................................... 12 3.5.2. Signatures ........................................................................................................................... 14 3.5.3. Transfers ............................................................................................................................. 14 3.5.4. Shared ................................................................................................................................. 14 4. ACCOUNT SETTINGS ........................................................................................................................... 15 4.1. How to Change Your Password .................................................................................................. 15 4.2. How to Change Your Personal Account Information ................................................................ 16

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Making Ontario a preferred location for Global Clinical Trials, while maintaining the highest ethical standards.

CTO Stream (Applicant) - Getting Started

1. ABOUT CTO STREAM ............................................................................................................................ 2

1.1. Target Audience ........................................................................................................................... 2

1.2. How to Access the System ........................................................................................................... 2

1.3. Internet Settings ........................................................................................................................... 2

1.4. Technical Support ......................................................................................................................... 3

2. GETTING STARTED ................................................................................................................................ 3

2.1. CTO Stream Home Page ............................................................................................................... 3

2.2. How to Register a New Account .................................................................................................. 4

2.3. How to Log In ................................................................................................................................ 5

3. NAVIGATING CTO STREAM .................................................................................................................. 5

3.1. Work Area ..................................................................................................................................... 6

3.2. The Navigation Menu ................................................................................................................... 6

3.3. Contacts ........................................................................................................................................ 7

3.4. Actions Toolbar............................................................................................................................. 8

3.4.1. Create Project ....................................................................................................................... 8

3.4.2. Delete Project ....................................................................................................................... 9

3.4.3. Duplicate Project ................................................................................................................ 10

3.4.4. Transfer ............................................................................................................................... 11

3.5. General Menu ............................................................................................................................. 12

3.5.1. Notifications ....................................................................................................................... 12

3.5.2. Signatures ........................................................................................................................... 14

3.5.3. Transfers ............................................................................................................................. 14

3.5.4. Shared ................................................................................................................................. 14

4. ACCOUNT SETTINGS ........................................................................................................................... 15

4.1. How to Change Your Password .................................................................................................. 15

4.2. How to Change Your Personal Account Information ................................................................ 16

Clinical Trials Ontario Page 2 of 16 Online User Guide: Getting Started V1.0

1. ABOUT CTO STREAM

CTO Stream is a web based electronic platform for coordinating research ethics reviews and is built using modern infrastructure which exhibits a vast set of features while maintaining an easy-to-use interface. CTO Stream has been developed to meet the needs of researchers and REBs across the province by enabling research ethics review, document management and communication between multiple institutions and REBs. CTO Stream is designed for any multi-site clinical research. All studies will use the same interface and REB application forms, regardless of which REB is pending oversight. Furthermore, CTO Stream is built on the principles of transparency and consistency in submission requirements. CTO Stream has been developed in partnership with Infonetica Ltd. This continued relationship ensures that CTO Stream will be continuously monitored and maintained to meet the needs of researchers and REBs across the province.

1.1. Target Audience

This guide is intended for all CTO Stream Users and will provide useful information for first time users on how to create an account and navigate the online application system.

1.2. How to Access the System

To access CTO Stream, go to https://apply.ctostream.ca

1.3. Internet Settings

CTO Stream supports the latest versions of the following browsers: o Microsoft Internet Explorer o Mozilla Firefox o Google Chrome o Apple’s Safari

CTO Stream uses pop-ups. You will need to configure your browser to ensure CTO Stream pop-ups are allowed.

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1.4. Technical Support

Email – [email protected]

Phone – 1-877-715-2700

2. GETTING STARTED

2.1. CTO Stream Home Page The CTO Stream home page can be accessed using the following link: apply.ctostream.ca.

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2.2. How to Register a New Account

If this is your first time using CTO Stream you will need to create a new account. If you have used the system before, please skip this step. To register, click the “New User” button.

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This will bring you to the Registration page.

Complete the information required, review and agree to the Terms and Conditions and Privacy Policy and click “Register” to submit your application. You will receive an email to the email account you have specified to verify your account. Once your identity is verified you will have access to CTO Stream.

2.3. How to Log In Once you have completed the registration process, enter your registered email address

and password and click Log In.

3. NAVIGATING CTO STREAM Upon logging into CTO Stream you will be directed to the Work Area. The Work Area is your home page where you will find all current pending notifications, create new projects or enter existing projects to continue the application process.

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3.1. Work Area

1. Your profile name will be displayed here. Click on your profile name to reset your password, change your personal information or logout. For more information go to Section 4 of this guide.

2. The Navigation menu - the Navigation menu is visible from any page or workspace in the system. For more information go to Section 3.2.

3. The Work Area toolbar - from here you can return to the Work Area page at any time. You can also view your system Notifications. The Work Area toolbar is visible from any page or workspace in the system.

4. The Actions toolbar - from this toolbar you can create a new folder, delete a folder, create a new project, delete a project, duplicate a project or transfer a project to another user. For more information go to Section 3.4.

5. The General Menu - from this menu you can view your system Notifications, Signatures, Transfers and Shared Projects. For more information go to Section 3.5.

6. The Projects Menu - from this menu you can view previously created projects.

3.2. The Navigation Menu The Navigation menu will always be visible at the top of the page no matter where you are in the system, with links to:

1. Home – takes you to the Work Area home page 2. Contacts – takes you to the Contacts page. For more information please refer to

section 3.3 3. Help – The help bar links to:

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a. Contact Information – Provides contact information for Clinical Trials Ontario

b. Help – Provides contact information for all support issues c. FAQ – Links to Frequently Asked Questions d. About – Provides information about Clinical Trials Ontario

3.3. Contacts This page lists all of the contacts you have saved to your personal address book in CTO Stream. These contacts can be imported directly into new and current application forms that have not been submitted.

To add a new contact, click the + Add Contact. This brings up the New Contact registration dialog box. Once the information for the contact has been entered it can be saved to your contacts list.

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3.4. Actions Toolbar The Actions toolbar will display all of the actions that are available in CTO Stream. The Actions toolbar is dynamic and will only display the actions currently available to the user.

3.4.1. Create Project

Clicking the Create Project tile will bring up the Create Project dialog box.

Enter a Project Title and click Create. The Project you have just created can now be found in the Project Menu on the Work Area.

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The Project Title is an important field as it will be used to label your project on the Work Area. It will also be included in all system notifications as well as correspondence with the REB (including letters). Once a project has been approved by the REB, the Project Title can only be changed through an amendment.

3.4.2. Delete Project

Clicking the Delete Project button will bring up the Delete Project pop-up window. Select the project from the drop-down list that you want to delete and click the Delete button. Projects which have been submitted for review cannot be deleted.

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3.4.3. Duplicate Project

Clicking the Duplicate Project tile will bring up the Duplicate Project dialog box. Select the project from the drop-down list that you want to duplicate and click the Duplicate button.

Duplicating a project will create an exact replica of the project including all of the applications associated with the project, but excludes any documents uploaded in the original project (i.e. protocols, consent forms, etc.). The duplicated project will appear in your Projects Menu.

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3.4.4. Transfer

CTO Stream facilitates transferring the ownership of a project from one person to another. Only the current project owner has the ability to initiate a transfer. Once the project is transferred to another individual, it will no longer be listed on your project list and you will no longer have access to it unless the new owner shares the project with you.

Clicking on the Transfer button will bring up the Transfer Projects dialog box. Select the project you want to transfer from the list by clicking on the checkbox next to the User Project Id or search for the project you want to transfer. Input the email address of the person you are transferring the project to. You can also enter a message to accompany the transfer.

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Once the Transfer request is complete the transfer recipient will receive a notification through CTO Stream and his/her personal email. The transfer recipient can then accept or reject the transfer.

3.5. General Menu The General Menu is the main hub for all notifications based on four distinct categories. The number listed in the corresponding tile is the number of unread notifications.

3.5.1. Notifications

Users will receive notifications whenever an event occurs on an application form within a Project. Clicking on the Notification tile will bring you to the Notifications page.

1. You can search through the available notifications by keywords. 2. You can search through the available notifications by start and end date.

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3. The display slider can be used to change the number of notifications that are returned as results once a search is completed.

4. The check box to the left of each message can be used to select one or more messages at one time. You can select all messages at once by clicking on the checkbox at the top left hand of the page. 5. Selected messages can be marked as unread, marked as flagged, or deleted. Deleted notifications cannot be recovered.

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3.5.2. Signatures

Clicking on the Signatures tile will bring you to the Signatures page.

You can search through your pending and previous signature requests using the following criteria: Project Title, Requesting User Name and Requested Date.

3.5.3. Transfers

Clicking on the Transfers tile will bring you to the Transfers page. You can search through the pending/completed transfer requests using following criteria: Transfer ID, Project Title, User Name and Date.

3.5.4. Shared

Clicking on the Shared tile will bring you to the Shared Forms page. You will be presented with a list of forms that have been shared with you, along with related information.

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To view the form that has been shared with you click on the View Form Button. The share can be rejected as well should you no longer want to be a collaborator on an application form. Shared projects will also be available under the Project Menu in the Work Area.

4. ACCOUNT SETTINGS The upper right hand corner of the Work Area will list the profile name you are currently logged into. Clicking on your profile name will bring up two general account links.

4.1. How to Change Your Password Click on the Change Password link. This will direct you to the change password page. Enter the required information to change your password. Passwords must contain at least seven characters and include an uppercase letter, lowercase letter and a number.

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4.2. How to Change Your Personal Account Information Click on the Personal Details link. This will direct you to the Change Personal Details page. From this page you can update or alter any information associated with your account.