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SDE is a secure website that allows investigators and site staff to access safety documents related to clinical trials. It replaces email distribution of these documents. Key benefits of SDE include faster and more secure notification of safety information, 24/7 access to documents, and efficient tracking and archiving. Documents provided on SDE include SUSAR reports and the Investigator Brochure. To grant users access to SDE, their contact information must be verified. Users will then receive login credentials and training on using the system.
SDE is a secure website that allows investigators and site staff to access safety documents related to clinical trials. It replaces email distribution of these documents. Key benefits of SDE include faster and more secure notification of safety information, 24/7 access to documents, and efficient tracking and archiving. Documents provided on SDE include SUSAR reports and the Investigator Brochure. To grant users access to SDE, their contact information must be verified. Users will then receive login credentials and training on using the system.
SDE is a secure website that allows investigators and site staff to access safety documents related to clinical trials. It replaces email distribution of these documents. Key benefits of SDE include faster and more secure notification of safety information, 24/7 access to documents, and efficient tracking and archiving. Documents provided on SDE include SUSAR reports and the Investigator Brochure. To grant users access to SDE, their contact information must be verified. Users will then receive login credentials and training on using the system.
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