Here at Geneuity Research Services, we do laboratory tests for clients conducting clinical trials. We are a one-stop shop, handling everything from routine clinical assays to esoteric molecular analyses. We use OpenClinica as an in-house LIS to keep track of workflow and to help with administrative tasks like billing and specimen archiving. This isn’t exactly what the developers of OpenClinica had in mind originally. The application was designed from the point of view of trial sponsors, not their subcontractors. But it works very well for us nonetheless. In this article, we briefly describe how we do it.
As everybody who uses OpenClinica knows, defining your event x
CRF matrix is the most important step in configuring a trial. When a
client comes to us with a new trial, we do just that. We are careful
to reproduce the anticipated flow of events and patient groupings
just as designated by the trial’s specifications. “Why bother?”
you’re probably asking. “You’re just a subcontractor. That’s not your
concern.” But it is. Invariably, specimens get mislabeled and
inappropriate tests get ordered, and we’re able to detect many such
mistakes by doing a quick visual inspection of OpenClinica’s patient
x event dashboard with its easy-to-take-in iconification. We feel
that this double-checking is part of our service to the sponsor.
CRF design is our next consideration. In this case, we don’t
try to reproduce everything required from the sponsor’s point of
view. Instead, we design a set of CRF’s that reflects just our role
as a contract clinical laboratory. This means that our CRF’s are far
more narrowly focused and less complicated. But it also means we
include some unique types of fields for pricing, specimen archiving
and the like, items that a trial sponsor usually doesn’t need to
address in their CRF’s but which are very helpful to us.
We are very careful how we name our items when crafting our
CRF’s. Specifically, we use the same terminology across our trials
whenever possible. For instance, the field for a specimen’s accession
number is always named ‘accession_number‘. Likewise, we consistently
use the names ‘freezer‘, ‘received_date‘, ‘price‘, ‘shipping_deviation‘
and ‘%assay_date‘ (where % is the wildcard string).
Using such a controlled vocabulary is vital in our case because
we use a separate installation of OpenClinica for each study and
employ the postgresql contrib module ‘dblink’ to federate their
attendant databases for querying. A helterskeleter vocabulary would
render the latter problematic, to say the very least.
For example, we wrote a federated database procedure we call
accessions(). When executed, it consults the accession_number field
in all our installations and returns the number of accessioned
specimens broken down by trial name. Collectively, they provide us with a realtime, global snapshot of
our workflow and freezer contents.
Because OpenClinica is web-based and has finely grained user
roles, our clients can remotely log into their respective
installations at our site with read-only privileges and see the
status of their specimens whenever they want. Conversely, when we
think a specimen has been mislabeled or have some other issue, we can
call a client and direct them to a particular URL displaying the
pertinent information and seek clarification. OpenClinica thus
becomes a shareable laboratory notebook between us and our clients.
The bottomline: OpenClinica works for Geneuity. Because
OpenClinica is open source, elegantly designed and well documented,
we are able to tailor the application to our needs. In the spirit of
mutual collaboration and aid fostered by OpenClinica’s lead
developers at Akaza Research, we’re making our federated procedures
freely available.