For small or part-time sites that cannot justify a
full-time DCO, a well-trained coordinator can
assume this function.
Quality assurance
Putting systems in place to assure product quality is
a standard business process. According to the Inter-
national Standardization Organization (ISO 9000),
quality assurance is defined as a set of activities
whose purpose is to inspire the confidence of cus-
tomers and managers that all quality requirements
are being met for a product or service (ISO 9000
definitions).
The investigative site should have a keen interest
in adopting quality assurance methods to ensure its
clients – sponsors and CROs – that it is achieving
its goal of turning out a quality product, clean data.
The way to accomplish this goal is by assigning an
individual to review the site’s adherence to GCP
guidelines, its handling of clinical data, its atten-
tion to patient safety and protection and its adher-
ence to standard operating procedures (SOPs). The
QA professional should establish specific time
intervals for routine review of CRFs, certainly at
study start-up and once a month thereafter.
Because mistakes in data collection and reporting
are most likelyto occurat study start-up,itis agood
idea for the QA manager to review the first three to
five charts.
Attention to detail will also serve to improve the
outcomes of visits from study monitors. As a repre-
sentative of the sponsor or CRO, the monitor’s job
is to ensure that the study protocol is being adhered
to and that the clinical data are properly collected,
recorded and forwarded (Miskin and Neuer, 2002).
A quality site treats the monitor with respect and
provides a quiet space in which the monitor can
work.
Writing of SOPs
The writing and implementation of SOPs form
the framework of a quality operation by defining
expectations and providing a consistent approach
to drug development at the sponsor, CRO and
site levels (Hamrell and Wagman, 2001). SOPs
for the site are best developed with input from
all levels of site management, and should describe
how each member of the clinical research team
is to complete various tasks. The SOP should
state its objective, mention to whom it applies,
define terms or abbreviations, describe tasks in
a step-by-step manner, include appropriate check-
lists or forms and list any associated SOPs
(Miskin and Neuer, 2002). Because the industry
is not static but is constantly changing, it is a
good idea for the head of quality assurance to
review the SOPs annually to evaluate the need for
updates.
Standardizing procedures becomes particularly
relevant as sites grow internally or eventually
expand into more than one location. In addition,
employee turnover is inevitable, so the SOPs can
serve as a basic element of the training program for
new hires.
There is a whole host of SOP topics for the
investigative site, ranging from study management
to patient recruitment to handling of accounts
receivable. Some study management SOPs appear
in Figure 11.4 (Miskin and Neuer, 2002).Regulatory affairs
Clinical trials cannot operate without regulatory
oversight. Regulatory agencies from each country
or region promulgate guidelines and regulations
for conduct of ethical clinical research by industry
and government sponsors. As part of that chain,
investigative sites share the responsibility for con-
forming to federal guidelines and regulations, and
do so by receiving training that defines what their
responsibilities entail.
At the site level, there is a growing amount of
regulatory responsibility, particularly in countries
that have adopted ICH GCP guidelines or similar
regulations. Everything from submissions to insti-
tutional review boards (IRBs) or ethics commit-
tees, completion of the Statements of Investigator
Form 1572 and financial disclosure forms (US),
maintaining of the regulatory binder and the11.2 BASIC INFRASTRUCTURE 131