Grid Security - Grid Computing: Infrastructure, Service, and Applications - page 316

matters related to the clinical trial, including potential benei ts, potential
dangers, how the collected information will be used within the trial, and
potentially any plans for future use of the data. One of the challenges here
is that it is essential that patient consent is obtained before any access to
identifying patient data is made.
Once a set of patients have been identii ed, invited to join a particular
trial, and subsequently accepted, the next phase is typically focused on
the actual undertaking of the trial itself. This includes collecting data on
the patients throughout the course of the trial. If the trial is concerned
with drug evaluation, say, then it is typically necessary to randomize
patients with some patients being given the drugs to be evaluated and
others a placebo: double-blinding is often used here, where neither the
patients nor those running the trial are aware of who is receiving the
drug/placebo to avoid potential bias. Instead, a trusted third party is used
to keep this information. Tracking and monitoring the patients through-
out the trial is typically essential to ensure that all necessary information
is collected. In some circumstances, this monitoring and follow-up can
run for many years—and can often lead to insights on the long-term
effects of particular treatments, for example.
Throughout the whole trial process it is essential that the trial is con-
ducted according to a strictly dei ned protocol. This will typically
describe what information is being collected, for what purpose, as well
as how it will subsequently be used within the trial and any potential
follow-up on trials or studies. In all of these phases it is essential to
ensure that the different people with different roles within the trial can
only access and use the datasets and services associated with their
particular role in the trial.
The grid infrastructure developed within VOTES has been described in
[29,30]. In brief, the VOTES infrastructure is based upon a portal that
provides access to a range of distributed services through which various
clinical datasets can be accessed and used. The services themselves have
been implemented using grid middleware such as Globus Toolkit version 4
and the OGSA-DAI software. The current implementation combines
access to and usage of a range of software and datasets in widespread use
across the NHS in Scotland. These include access to Scottish Morbidity
Records (SMR)—one of the most comprehensive clinical data repositories
in the UK. The SMR datasets are constructed in conjunction with the
General Register Ofi ce (GRO) for Scotland. For the purposes of the VOTES
project, a subset of over 4 million records of the data has been provided by
the NHS covering over 30 years of patient data and care related to hospital
discharges, psychiatric admissions and discharges, cancer registrations,
and deaths. It is worth noting that the NeSC employees working on this
project have been granted NHS Honorary accounts. Close collaboration
with the NHS is essential in supporting the development of services pro-
viding access to clinical data.