Corporate Services: Information Technology

QUICKGUIDEClinical Program

Late Phase Pharma Clinical Program

PAREXEL © 2011

eClinical DashboardKEY FEATURES INCLUDE: – Access to applications such as Electronic Data Capture (EDC).

– Latest news and information of interest to your research site.

– A collaboration area to share information with other clinical sites.

– Repots relevant to your site.

– Training and Documentation: Important guidelines and answers to common questions.

– Access to download the fully approved Regulatory Document package completed by your site.

Managing Your User AccountTO RESET YOUR PASSWORD – On the login page click Forgot Password. Enter your email to receive a link to a

page that resets your password using the security challenge set during registration.

– Once logged into the system, click your user name in the header to open your user profile. On this page you can enter a new password for your account.

TO INVITE A STAFF MEMBER – From the user profile, invite new site members to register by entering their email

address and roles. They will receive a link by email to complete and submit the registration form.

– In addition, all account management features can be initiated by a phone call to the Service Desk.

Regulatory DocumentsThe completion for a Regulatory Documents package is required in order to qualify your site for participation and ensure that it meets regulatory standards.

FOR EACH REGULATORY DOCUMENT:1. Review the instructional text.

2. Click the Download Template button to download a copy of the document to fill out and complete.

3. Click the Upload button to add your updated version of the downloaded document.

4. You may also ship the document using the box icon to indicate it is being sent and provide the shipment details.

Once your entire Regulatory Document package is approved you will be invited to begin the Site Initiation process.

InitiationAll site staff members will be contacted for initiation on the tools and protocols necessary to conduct the study. This includes knowledge assessments to validate the initiation.

After the initiation is approved for each site staff member, a notification is sent providing access to the eClinical Dashboard.

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Corporate Services: Information Technology

IntroductionWHAT IS eCLINICAL WEB PLATFORM?

eClinical web platform is a web-enabled site registration portal that enables remote collection, review and processing of required documents (e.g., the Confidential Disclosure Agreement, site contract and regulatory documents).

KEY FEATURES

� Intelligent, guided user interface (embedded workflow), prompts and notifications.

� Globally accessible and configurable to support global regulatory requirements.

� Designed to be self-managing (e.g., users can update personal settings and reset password from the landing page).

� Automation and simplified access to systems.

� Site qualification features.

� Support for research and technology naïve sites in clinical research.

� Current information for site and client communities.

� Context sensitive help on each page.

� Personal task manager.

� User profile edit (user name in the page header).

Using the hyperlink provided in your email invitation, the Prinicipal Investigator must complete the registration form to create a user account within the eClinical web platform and begin the qualification and document collection processes.

1. Begin by reviewing the populated information which was provided through the pre-qualification questionnaire. If any of this information is inaccurate or out of date, contact your assigned PAREXEL contact.

2. Confirm your unique email address to be used as a User Login for all connected applications (user access should not be shared with other site staff).

3. If you wish to designate a site coordinator to assist in the qualification and document processes, enter their information here. They will receive an invitation email to a similar form for user registration.

4. Create and confirm a password and security question.

5. Click Submit upon completion. If you are unable to complete the form at this time, click Cancel and return later using the email hyperlink.

Confidential Disclosure AgreementAfter your registration is approved, you will receive an email notification with a hyperlink guiding you to complete the Confidential Disclosure Agreement (CDA). This is the first document in a series of regulatory documents required to complete the site qualification. This agreement outlines confidential information that the parties wish to share with one another, but wish to restrict access to third parties.

1. Open and review the CDA

IF NO CHANGE IS REQUIRED TO CDA:2. Click ACCEPT THIS AGREEMENT. A second window will pop-up and allow

you to enter your electronic signature.

3. Read the electronic signature statement and, if you comply with it, check the confirmation box.

4. Enter the email address used as user login and then the password.

5. Click Submit to perform electronic signature.

IF CHANGES ARE REQUIRED TO CDA:

6. Click I DO NOT ACCEPT THIS AGREEMENT

7. Click the Download Original Document button.

8. Edit the downloaded document to provide desired changes with your comments and save to local drive.

9. Click Upload Document to upload the revised CDA or your own new CDA.

10. Or, you may also click the box icon to indicate that you are mailing the document.

PAREXEL © 2011

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Registering Your Site

CONTACT

Phone: 000.000.0000 Address: xxxx, ### xxx street, town, state, zip

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