Digital Platform: CTO Stream

All Researchers, Sponsors and CRO users can create an account directly from the applicant login page. To access this page please click the following link: https://apply.ctostream.ca

All REB users must contact CTO to have an account created. Please email streamline@ctontario.ca for more information.

To access CTO Stream you will require a computer, tablet or smart phone, internet connection and a supported browser. Below is a list of browsers that are supported. Please ensure that your browser is updated to the LATEST VERSION:

• Google Chrome
• Firefox
• Microsoft Edge
• Safari

If your browser is not listed above it is not supported for use with CTO Stream. You will need to install a supported browser, or contact your IT department to do so.

The user who creates a new study in CTO Stream will automatically be given the role of Project Owner. The Project Owner has the ability to create/edit any application form and add or remove any roles or sharing privileges. It is recommended that the Sponsor, Provincial Applicant or study-wide research coordinator create the study in CTO Stream and act as the Project Owner.

The Project Owner is the ONLY user who can upgrade the study when CTO releases a new set of application forms into the system.

Please ensure that if the Project Owner is leaving the study, they transfer the ownership to a different user. For more information please consult the manuals and quick guides.

When a study is first created, only the project owner (the person who created the project) will be able to see and access the study. The project owner will need to use the collaboration features to give access and permissions to other research team members. Once other users have permission (e.g., through their new role or when the form is shared), they can also use the collaboration features to set up collaborators at their site.

The ‘Roles’ functionality is the most commonly used collaboration feature because it gives the user access and permissions for the entire study period. This means that, as new application forms are created, users with the appropriate role will automatically be given corresponding access and permissions. Similarly, if a user is given a role later in the life of the study, they will have access and permissions to currently existing forms and all previous forms based on their role. For more information please consult the manuals and quick guides.

CTO Stream utilizes two sets of standardized forms: one for clinical trials and the other for observational research. Each form has built in ‘smart logic’ to ensure that applicants will only need to answer questions or upload documents that are relevant to their research.

The application form templates are for reference purposes only and can be found on the Tools and Resources page. Research teams must login to CTO Stream in order to complete and submit their applications for REB review.

The CTO Informed Consent Form Templates serve as the basis for the consent form for studies The CTO Informed Consent Form Templates serve as the basis for the consent form for studies using CTO Stream. The appropriate template should be used when creating the study-specific consent form submitted with the initial study-wide application (the Provincial Initial Application) in CTO Stream. Please select the appropriate template(s) based on the type of research you are submitting. Please ensure you follow all of the instructions listed on the first page of the template as this will ensure a faster time to ethics approval. You can find the CTO Informed Consent Form Templates on the Tools and Resources page.

If you are submitting an oncology study through CTO Stream to be reviewed by the Ontario Cancer Research Ethics Board (OCREB) please use the OCREB Informed Consent Form Template which can be located here: https://ocreb.ca/about-ocreb/guidelines-templates-and-sops/.

Please note that as of May 1st 2019, all* studies being submitted through CTO Stream must use the CTO Informed Consent Template located on the Tools and Resources page.

*excluding studies being submitted to the Ontario Cancer Research Ethics Board (OCREB), which are required to use the OCREB templates on the OCREB website: https://ocreb.ca.

Privacy Policy

This Privacy Policy applies solely to Clinical Trials Ontario’s CTO Stream (the “Website”).

The software and web services are provided by Infonetica Ltd (“Infonetica”).

Reference to “we” are to Clinical Trials Ontario and/or Infonetica.

By accessing the Website the user consents to the collection, use and transfer of the information that you provide in accordance with terms of this Privacy Policy and the Website’s Terms and Conditions.

By accessing the Website you agree to the terms of this Privacy Policy and the Website’s Terms and Conditions and consent to the collection, use and transfer of the information that you provide in the use of the Website.

Clinical Trials Ontario and Infonetica are committed to safeguarding the privacy of our Website visitors and this policy sets out the basis on which any personal information we collect from you, or that you provide to us, will be processed by us. Please read the following carefully to understand our views and practices regarding your personal data and how we will treat it.

For the purposes of the Data Protection Act 1998 (the “Act”), the data controller is Clinical Trials Ontario of 661 University Ave, Suite 460, Toronto, ON. M5G 1M1.

Information we may collect from you

We may collect and process the following data from you:

• Your contact information, e.g., first and last name, address, phone, fax (if applicable), and email address (to set up your user account);
• Your operating system, browser, IP address (a number assigned to your computer to identify it on the network);
• The pages you browse;
• The referring page that led you to the current page; and
• Your software and aspects of its configuration.

Furthermore, if you contact us, we may keep a record of that correspondence. If you choose to provide CTO with additional information about yourself, e.g., through an email message, any identifying information that you provide may be retained.

This information is available to the Website’s administrators and is used for audit purposes.

Cookies

A cookie consists of information sent by a web server to a web browser, and stored by the browser. The information is then sent back to the browser each time the browser requests a page from the server. This enables the web server to identify and track the web browser.

We use session cookies on the Website to keep track of you whilst you navigate the Website. Session cookies will be deleted from your computer when you close your browser.

To maintain and improve the quality of the Website, we use Google Analytics. Google Analytics generates statistical and other information about the Website use by means of cookies, which are stored on user’s computers. The information generated relating to our Website is used to create reports about the use of the Website. Google will store this information. Google’s privacy policy is available here.

Where we store your personal data

We will take all steps reasonably necessary to ensure that your data is treated securely and in accordance with this privacy policy. We will store all of your personal data on our secure servers.

Data transmission over the internet is inherently insecure, and although we will do our best to protect your personal data, neither Clinical Trials Ontario nor Infonetica can guarantee the security of the data you transmit to the Website and any transmission is at your own risk. Once we have received your information, we will use appropriate security procedures and features aimed at preventing unauthorised access, unlawful processing, accidental loss, destruction or damage.

You are responsible for keeping your password and user details confidential. We will not ask you for your password except when you log into the Website.

Uses made of the information

The personal information and research project information you submit to the Website is collected and stored for the purposes of:

• Operation and administration of the Website;
• Enabling your use of the services available on the Website, including making research applications; and
• Dealing with enquiries made by you relating to the Website or its use.

Personal information and project information will not be released to third parties except when authorised by the user (e.g. submission of application forms) or required by law.

Third party websites

The Website contains links to other websites. Clinical Trials Ontario and Infonetica are not responsible for the privacy policies or practices of third party websites.

Amending theses Terms and Conditions and/or the Website’s Privacy Policy

From time to time Clinical Trials Ontario may at its sole discretion amend this Website’s Privacy Policy. Your continued use of the Website constitutes your acceptance of and agreement to any changed Terms and Conditions and/or Website’s Privacy Policy. Clinical Trials Ontario will ensure that details of any such changes are posted on the Website in a timely manner.

Contact

Questions, comments and requests regarding this privacy policy are welcomed and should be addressed to: streamline@ctontario.ca

Terms and Conditions

Disclaimer

This Disclaimer applies solely to Clinical Trials Ontario’s Stream (the “Website”). The software and web services are provided by Infonetica Ltd (“Infonetica”).

Reference to “we” are to Clinical Trials Ontario and/or Infonetica.

By accessing the Website the user agrees to these Terms and Conditions and the Website’s Privacy Policy and consent to the collection, use and transfer of the information that you provide in the use of the Website.

Clinical Trials Ontario and Infonetica provide the Website to you without any conditions, warranties or guarantees (whether express or implied), including but not limited to any implied warranties or conditions as to the satisfactory quality of fitness for a particular purpose, which are expressly excluded to the extent permitted by law.

Your use of the Website

You may only use the Website for lawful purposes related directly to the use of the CTO Streamlined Research Ethics Review System. You may not use, and shall take all reasonable steps to ensure that no other person uses, the Website in a way that does not comply with the terms of any laws applicable to you or that is in any way unlawful.

You agree:

1. To comply with any legal notices contained on the Website;
2. To respect and comply with the legal rights of others, in particular our rights (including our rights in copyright and trade marks), and the rights of our licensors; and
3. Not to use this Website for any personal commercial gain, nor to sell or trade in any of the content or other material copied or downloaded from this Website without our expressed written permission;
4. To not upload or otherwise incorporate personal information or personal health information about a research participant into the Website. In the event that this information is inadvertently uploaded or incorporated, you agree to immediately notify CTO;
5. To maintain the confidentiality of the information and/or documents contained in the Website.

Users should notify CTO when they no longer require access to the Website.

Liability Statement

Clinical Trials Ontario and Infonetica try to make sure that all information on the Website is correct, and (without giving any warranty or undertaking in this regard) Clinical Trials Ontario will and will procure that Infonetica will use all reasonable care and skill to do so. However, subject to the paragraph entitled ‘Exclusions by Law’ below, neither Clinical Trials Ontario nor Infonetica accept liability for any error or omission and exclude all liability, either jointly or severally, for any action you may take or loss or injury you may suffer (whether direct, indirect or any consequential or special loss) howsoever arising out of or in connection with the use of this Website.

Exclusions by Law

Nothing in these Terms and Conditions or the Website’s Privacy Policy shall or shall be deemed to exclude or limit liability for death or personal injury caused by Clinical Trials Ontario or Infonetica’s own negligence or for any fraud perpetrated by Clinical Trials Ontario or Infonetica. For the avoidance of doubt, to the extent that Clinical Trials Ontario or Infonetica are liable by operation of the above Exclusions by Law paragraph, such liability shall not be several and not joint.

Availability of the Website

Clinical Trials Ontario and Infonetica make reasonable endeavours to ensure that the Website is generally available but neither makes any representation or guarantee as to such availability. Neither Clinical Trials Ontario nor Infonetica take responsibility for and will not be liable for the website or any interfaces with other systems being temporarily unavailable, or resulting in loss or corruption of data due to technical issues beyond the reasonable control of Clinical Trials Ontario and Infonetica.

Privacy

Any information generated by you visiting the Website will be handled in accordance with these Terms and Conditions, the Website’s Privacy Policy and where applicable the Data Protection Act 1998. Information entered into the Website for the purpose of using the CTO Streamlined Research Ethics Review System includes confidential documents including, but not limited to, protocols, Investigator Brochures (IB), Product Monographs (PMs), Device Manuals, Health Canada documentation, and other confidential information related to a research study. By using this website, you agree to maintain the confidentiality of the documents and information you access. Any unauthorized use of the content of the Website is prohibited, including reproduction and/or dissemination of the content for unauthorized purposes and/or by or to unauthorized users.

Virus protection

While Clinical Trials Ontario and Infonetica make every effort to check and test material at all stages of production, Clinical Trials Ontario and Infonetica are unable to guarantee that the Website will never be faulty, free of viruses and/or errors, nor that it will work continuously, nor that it will be maintained in a fully operational condition. It is always wise for you to run an anti-virus program on all material downloaded from the internet. Clinical Trials Ontario and Infonetica cannot accept any liability for any loss, disruption or damage to your data or your computer system, which may occur whilst you are using the Website or material derived from the Website. Users must not misuse the Website by knowingly introducing viruses, trojans, worms, logic bombs or other material which is malicious or technologically harmful. Website users must not attempt to gain unauthorised access to the Website, the server on which the Website is stored or any server, computer or database connected to the Website. Users must not attack our site via a denial-of-service attack or a distributed denial-of service attack. If you breach this provision, you will have committed a criminal offence under the Computer Misuse Act 1990. Clinical Trials Ontario and/or Infonetica will report any such breach to the relevant law enforcement authorities and will co-operate with those authorities by disclosing the website user’s identity to them. In the event of such a breach, the website user’s right to use the Website will cease immediately.

Changes to the Website

We may make changes to and means of accessing the Website at any time and without prior notice. If the need arises, Clinical Trials Ontario and Infonetica reserve the right to suspend access to or close the Website permanently without prior notice. Whilst every effort is made to keep the Website up to date, any of the material on the Website may be out of date at any given time.

Copyright and intellectual property

You acknowledge that all rights in copyright, patents, design rights, trade marks and other intellectual property rights (whether registered, capable of registration or otherwise) throughout the world (“IP Rights”) in the Website (including all content) are owned by Clinical Trials Ontario and/or its licensors for the full duration of such rights.

Except for your use of the Website in accordance with these Terms and Conditions and the Website’s Privacy Policy, you are granted no IP Rights in respect of the Website or its content.

As an individual or organisation, you may print paper copies and make copies to your hard drive of any of the names, images and logos identifying the Website provided that in doing so you comply with the following conditions:

1. You must ensure that the resource which you copy is used for research, training, private study or information only and is not used for direct commercial gain;
2. You must not modify the paper or digital copies of any materials you have printed off or downloaded in any way; and
3. You must ensure that the Website is referred to as the source of the resource that you have copied.
4. You must not change any of the text or images contained in this Website or merge it with any other text or images, or forge headers or otherwise manipulate identifiers in order to disguise the origin of any content.

Amending theses Terms and Conditions and/or the Website’s Privacy Policy

From time to time Clinical Trials Ontario may at its sole discretion amend these Terms and Conditions and/or the Website’s Privacy Policy. Your continued use of the Website constitutes your acceptance of and agreement to any changed Terms and Conditions and/or Website’s Privacy Policy. Clinical Trials Ontario will ensure that details of any such changes are posted on the Website in a timely manner.

Enforceability

If any provision of these Terms and Conditions is held to be invalid, unlawful or unenforceable to any extent, such provision shall not affect the validity, legality and enforceability of the other provisions of these Terms and Conditions.

Governing Law

The Ontario courts will have exclusive jurisdiction over any claim arising from, or related to, the use of this Website. These Terms and Conditions, the Website’s Privacy Policy and any dispute or claim arising out of or in connection with them or their subject matter or formation (including non-contractual disputes or claims) shall be governed by and construed in accordance with the laws of Ontario.

CTO will periodically send out communication emails to all affected CTO Stream users when features or processes are being added or changed in CTO Stream. The following table contains the most recent communications sent to CTO Stream users.

If you have any questions about CTO Stream or encounter an issue, please submit a ticket within the CTO Online Helpdesk at support.ctontario.ca