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Over the course of several months, we have concentrated
our efforts on establishing the technological and
operative infrastructure for the center. Experienced and
highly-skilled professionals have been hired for key
roles in the Information Security and Technology
Integration division (ISTI), Program Management and
Regulations division, Biostatistics division,
Communications division and the Education and Training
division. Currently, each division is drafting and
developing operational policies and standard operating
procedures outlining their roles, responsibilities and
services for the corresponding area.
Hardware and software to build the DTCC collaboration
tools infrastructure such as the RTRN Portal, CDMS and
multi-media communications to support day to day
technology operations of the staff and the RTRN
community has been acquired and deployed. Physical and
electronic security measures to protect the network
system, tools and data are in place and operational.
Systems for managing, archiving and storing
communications pertinent to the operations of the
network and its members have been established.
Evaluation of regulatory and governmental compliance
issues has been initiated as well as implementation of
“good clinical practices” and other industry-required
clinical training and certification efforts for the DTCC
staff. Training to use the collaboration tools has
commenced; introducing the RTRN community and members of
the RTRN Pilot study team to the technology and
resources available to enhance their research endeavors.
Continued support is being offered to the RTRN community
through the coordination and scheduling of webinars,
video conferencing and events to facilitate the
collaborative working relationships amongst the
researchers in the network.
Most importantly, we have established a leadership role
in the coordination of the RTRN Pilot Study which
includes assisting with the formation of the Pilot Study
teams; administrating communications between the RCMI
sites participating in the Pilot Study, and facilitating
the development of the electronic Case Report Forms (eCRFs)
that will be used to capture data throughout the Pilot
and other studies. Charged with achieving significant
milestones, the DTCC has formed solid strategic
alliances with stellar clinical data management,
research and technology organizations which are
providing valuable direction and resources to further
advance the efforts of the center. Since partnering with
Duke Clinical Research Institutes (DCRI), a renowned
institution with a 15-year history of successful
clinical research service, DTCC is identifying effective
operational strategies and streamlining the margin of
error typically associated with start-up organizations.
Working with technological leaders such as Database
Management Consulting, Inc. - certified ORACLE software
programmers, and Venture Technologies, the DTCC has
built a highly-advanced, secure and scaleable
technological infrastructure to support the work of the
18 RCMI sites and the more than 400 researchers being
funded through NIH grants. |
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