Content in this article relates to:
Cardiac Solutions
Clario Portal
This article shows you how to register a new research site and submit a Site Qualification Form (SQF) in the Clario Portal.
In this guide, you'll learn how to:
Register a new site for a study.
Add site contacts and assign roles.
Complete and submit the SQF.
Gain access to the site in the Clario Portal after submission.
Press play to watch the animated tutorial
Submit before the site initiation visit (SIV)
Submit the SQF at least 7 to 10 business days before the scheduled SIV date. This gives enough time to ship devices and prepare the study.
Some countries may need more time. Check with your sponsor or CRA for when the SQF should be submitted.
Summary of process steps
Start site registration
Open Register a Site / Join a Study, choose services and user type, confirm you're creating a new site, then enter your SQF PIN.
Enter site details and contacts
Enter site details, add the Principal Investigator, then add any other contacts who need Portal access.
Assign roles and answer site questions
Assign all required roles to contacts, then complete the Additional Site Information questions.
Review and submit the SQF
Review the SQF summary, submit the form, and confirm access from the confirmation email.
Before you begin
Make sure you have:
Access to the Site Qualification Quick Guide provided to the study team (includes your SQF PIN and Site Number)
Your SQF PIN
Your Site Number
1
Start site registration
Go to the study home page. Select Register a Site / Join a Study.
Select the Clario services you need for this study (this guide covers Cardiac Solutions, also known as Cardiac Safety), then Next.
Select your user type, then Next.
When asked if you're creating a new site, select Yes, then select Next.
Use Yes only for a brand-new site. If the site already exists and you only need to add users, select No and follow the on-screen instructions. That path doesn't start a new SQF.
Confirm you have the SQF PIN and Site Number from the Site Qualification Quick Guide, then select Next.
Enter the Qualification PIN, then Next.
When asked to confirm the study, select Okay. A joining message appears next. No action is needed.
If your Clario Portal account isn't linked to your Clario Global Account, you'll see Have an Account. Select Yes if you already have a Clario Portal account, or No to create one, then follow the on-screen instructions.
2
Enter site details and contacts
Enter the Site ID, time zone, primary site language, and whether the site is part of an institution.
Add the Principal Investigator (PI). Complete Contact Information, Contact Address, and Contact Summary, then select Next.
To add another contact, select Add Contact and complete the same contact sections, then select Okay. On Contact Summary, review the details and use the Edit icon if needed. When all contacts are added, select Next.
3
Assign roles and answer site questions
Assign roles to each contact. Select all required roles for the study.
Required roles are marked with an asterisk (*). Select every role marked with an asterisk. Roles control what users can do and see in the Clario Portal.
Answer the required Additional Site Information questions for your protocol, then select Next.
4
Review and submit the SQF
On the SQF Summary & Confirm page, review the information. Edit site details, contacts, or roles if needed. When everything is correct, select Submit SQF, or select Save & Close to finish later.
In the Confirm window, select Submit.
A confirmation message shows that the SQF was submitted.
Check your email for Successful Site Qualification Form Submission. Users added to the SQF should also receive confirmation and should now have access to the site in the Clario Portal.
Frequently asked questions
How do I view a saved SQF?
If you saved an SQF to finish later, use Viewing saved SQFs to open it and continue.
Need more help?
If you still need assistance after following this guide, contact Clario Customer Care. Use the Customer Care contact help for country-specific phone and email options. Be ready to share your study and site details when you reach out.
