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participation in IPV, and performance of study measures (blood pressure, waist 
circumference, height).  Cumulative data reports will be discussed with the Program 
Administrator and will be a regular agenda item of Steering and Protocol Oversight 
Committees. 
7.3.4.
 
Server Management and Data Center (Security) 
The servers involved in this project are contained within a secure data center with 
environmental controls which detect abnormal conditions such as power outages, high 
heat or humidity, and loud sound.  In the event of an abnormal condition, the system 
contacts three (3) individuals to notify them of the alerts. 

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Section 7 - Data Management (Phase 3 - 12/2010) 
Section 7 - Page 4 
 
The data center has several secure access points that are accessible only by a badge 
reader.  Only authorized staff will have accessible badges to these areas.  The building is 
surrounded by a 10 foot fence with a gate access through badge control.  The outside 
building door is accessed through badge control.  The data center room is housed in a 
locked computer room that is accessed through badge control.  Each of these access 
controls is in place 24 hours a day and seven days a week. 
All servers have uninterruptible power supplies (UPS).  The building has a backup 
generator that will automatically initiate in the event of a power failure. 
The computer room is equipped with fire suppression equipment.  This equipment is 
tested on a scheduled timetable by the institution.  The entire Data Center is fire-
protected by a clean agent system which is backed up by a dry-pipe pre-action sprinkler 
system.  The Data Center room is located on the second floor of the building in an area 
with no windows and has a raised floor to protect against flooding. 
The system is protected by a Cisco firewall and is located in a secure DMZ.  Servers are 
protected by institution supported and maintained intrusion detection software as well as 
by SecureIIS which monitors incoming server traffic. 
7.3.5.
 
Backups (Disaster Recovery) 
Nightly backups, moved offsite regularly, will be made of all data and stored in secure 
fireproof cabinets.  The backup schedule consists of full monthly backups and nightly 
incremental backups.  Backup tapes are kept indefinitely and therefore tapes are not 
rotated.  Backup tapes are handled by two system administrators.  Tapes are transported 
to offsite storage in locked containers and are stored in file proof cabinets. 
Tapes are identified by unique bar code labels accessible only by the systems 
administrators.  This is the only information on the tape label. 
The backup system stores the information for each bar code with details of 
directories/files backed up that includes the date and time of backup.  The backup system, 
when needing to restore files, will identify which tape is needed based on the bar code 
label.  Only designated system administrators can restore the backup tapes. 
Tapes are transported by one of two identified tape custodians.  The tapes are put in a 
metal, locked box and then transported from the data center to the offsite storage facility.  
At all times during the transport, one of the tape custodians is present with the locked box 
of tapes. 
7.3.6.
 
Tracking and Monitoring of Laboratory Data 
Study centers log each shipment of specimens sent to central laboratory by use of barcode 
labels that it will attach to all samples prior to shipment.  Once samples are received at 
the central lab, they are scanned into the central laboratory database.  This same process 

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Section 7 - Data Management (Phase 3 - 12/2010) 
Section 7 - Page 5 
 
is used when the Central Laboratory sends samples to an outside laboratory for testing.  
Central laboratory data is transferred electronically to reduce the possibility of error upon 
re-entry.  By using a web interface, data are transferred to a repository on the server.  If 
needed, firewall accounts can be obtained from the institution to allow outside 
laboratories to deposit data into the repository.  Specific import routines are developed to 
verify and merge these data with the main database. 
7.3.7.