For
data management, we have established a coordinating
data management center(DMC) directed by Stanly
Azen,
Ph.D. at USC. The DMC will organize all subject
enrollment, randomization, tracking, data entry
and analysis for each of the four projects and
across the projects. The DMC will be established
under the current, SCRC-an organized research
unit at the Coordinating Center's Institution.
Having a central data management unit will foster
systematic and common practices across the satellites
for implementation of the manuals of procedures(MOPs),
subject enrollment, randomization, tracking, data
entry, and regulatory operations(i.e., IRB, adverse
events). The DMC will also work with the investigative
team to develop a data dictionary for standardized
definitions of study variables across the satellites.
A common website for PTClinResNet will allow rapid
communication of study recruitment, changes in
procedures and new information across the sites
and projects. The website will have both public
and restricted areas to allow education fo the
public about the benefits of physical therapy,
and at the same time the restricted(password protected)
access will allow systematic subject enrollment
(with inclusion criteria checks), randomization(to
assist in the single-blinding process), data entry
for primary outcome measures (using common instruments),
and reporting of any adverse events required by
our regulatory agencies and IRBs. |
