Farida Souami

Project Manager, Quintiles

Secure Document Exchange/
SUSAR Reporting
Secure Document Exchange (SDE)
SDE is a secure website for the publication of
documents and allows investigators/site staff to view
and download safety documents
SDE allows external investigative staff, strategic
partners and internal employees to have access to all
relevant safety information on a continuous basis
SDE replaces e-mail distribution to investigators and
site staff and is the default mode of distributing all
safety information
SDE is rapidly becoming an industry standard for
study documents
Benefits of using a Web-Based System
Faster and more secure notification of safety
information without large e-mail attachments or
overflowing fax machines
24/7 access to all relevant safety documents
through a secure website
Capability for multiple study staff to receive safety
report alerts
Efficient tracking and electronic archiving capabilities
Less paper
What is sent via SDE?
SUSARs:
Expedited Safety Packages, Follow-ups, Cancellations,
Notifications, Six Monthly SUSAR Reports
Suspected, Unexpected Serious Adverse Reactions
Investigator Brochure (IB) is posted on the secure
website for reference
Other documents Non-SUSAR
What we need from you
To enable registration to the secure website,
you will be asked to verify the following information
for anyone requiring access to the safety documents
(investigators, coordinators, study nurses):
First name
Last name
E-mail address (unique for each person)
Phone number
Organization (= center name)
Country
Next Steps 1
You will receive an email message with a temporary
password and an invitation to attend an
e-learning module
This training session will take approximately
10 minutes
Once the training has been successfully completed,
each user will receive a new password for the
secure website
All safety information from Roche will then be
accessed using a link received via an e-mail alert
Or
If you have had previous experience with secure
websites or are unable to take the short e-learning
provided by IntraLinks, you will still be
granted access
You will be asked to provide your details and sign a
Training Acknowledgement Form (TAF)
This indicates whether you have read and
understood the manual or have had previous secure
document exchange experience
Next Steps 2
As soon as Roche receives this acknowledgement
you will receive an email containing your password
for the secure website
Once you have accessed the system this password can be
changed to one of your choice
Please note:
Using the TAF rather than the
e-learning does not allow your email address
to be tested by the system
Demonstration
1. How to access the link to the document in your
email alert
2. How to log in and navigate around the workspace
3. How to set your profile
4. How to get help
Safety Workspace Reference Guide is provided on
the meeting memory stick