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(Bio)Informatics Core
Protocol Data Management & Security Requirements
Every protocol should include elements
that address at least the following four areas. A short paragraph of a
few sentences should be sufficient in most cases. Contact Jeff Magouirk if you need any assistance
with planning or preparation for your study.
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Data Storage and Distribution: Where
will your data files, folders and information be stored electronically?
Specify any non-standard computer hardware or software that will
be used if other than that normally available and supported at UCD
and TCH. How will you transfer confidential data and information
to other individuals or locations for analysis where appropriate?
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Loss Prevention: Hard drives
do fail and your work can be lost. Be sure to state how you will
backup your electronic data and information. For example, back up
all study electronic materials to a network "share" (personal space
allocated on a network) on hospital equipment or a Pediatric CTRC
server. Note: This should NOT be an open network folder that anyone
can get access to. All UCD and TCH networked servers are backed
up nightly and have a verified procedure for restoration of data.
These networks also have emergency power supplies and disaster recovery
plans in case of power failure or catastrophic events. Optionally,
you can backup your study materials yourself with a local device
and media such as a zip disk or CD-ROM, especially for computers
that are not connected to a network.
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Secure Physical Location and
Access: For physical records, how will the documents be secured,
e.g., locked room, locked file cabinet, etc? Who other than the PI
or study coordinator has physical access to these documents (i.e.,
has a key or knows the door code)?
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Computer System Security: State
how access to your computer(s) holding confidential study data is
limited, for example through user sign-on and password protection
for operating system and network logins. Databases or important files/folders
should also be password protected. Consider how you should prevent
unauthorized access to confidential patient information (e.g., comply
with HIPAA regulations)? All UCD and TCH networked computers are
protected from unauthorized access with user-level, permission-based
security administration and with firewalls, and protected from viruses
with virus protection software that is constantly updated, so using
networked computers generally protects you technically from most
security risks. It is assumed that you will act professionally regarding
security procedures, such as using complex vs simple passwords;
not sharing your password with others; not writing your password
down near your computer; changing your password periodically.
Available Services
The following is a partial list of basic services offered by the (Bio)Informatics
Core. Contact the Informatics Manager,
Jeff Magouirk (720-777-8373) if you
have questions or comments.
- Research data definition
- Data collection/entry strategies and plans
- Data/file extraction, transformation, storage, archiving
- Database design and development
- Construction of custom database queries and reports
- Data/database migration and conversion
- Presentation, report and manuscript/publication assistance
- New technology evaluation, purchase, installation or setup
- Computer system inventories or upgrades
- Web site information sharing
- Web-based database development
- Web site development and maintenance
- Protocol security assessment and implementation
- Data backup and recovery plans and support
- Disaster recovery planning and support
- HIPAA (Privacy and Security) compliance for electronic data
(Bio)Informatics Core Mission
To accelerate the discovery of pediatric medicine and therapies
by leveraging technology to provide CTRC investigators with a user
friendly and value-adding information system while integrating available
applications in data management and security. The informatics core
will be responsive to investigator and CTRC staff needs, and lead
technical solutions in support of the long-term development of CTRC
capabilities in research and bioinformatics, including expanding
use of the Internet and other modes of wired and wireless connectivity.
We will lead improvements in processes and systems used in General
Clinical Research Centers, participate in cooperative efforts to
develop new technologies, and share this information with others.
Technology Strategy
The CTRC Program Guidelines require every Center to have a technology strategy
that helps to translate the many elements defined in the Guidelines into
specific approaches, plans, goals and infrastructure appropriate for each
individual location. The strategic elements of the Pediatric CTRC are:
- Leadership - provide technology direction inside and outside our Center
- Leverage - use all available institutional resources that are available
- Flexibility - support the science of clinical research quickly and
creatively
For questions or comments regarding computer systems and technology support,
contact the (Bio)Informatics at:
Jeff Magouirk
(Bio)Informatics Core Manager
720-777-8373
Ms. Swan Ellert
Protocol Data Collection Developer
720-777-4223
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