diary cards, dispensing records, quality-of-life
forms and so on. The CRF must allow for proper
analysis of the data and proper reporting of the
data in the final clinical study report, and it must
reflect the protocol exactly: no more and no less
data must be collected. Thus, a CRF must be
created for each clinical study and must be pre-
pared in parallel with the protocol. CRFs are
usually also prepared by sponsors/CROs because
of the demanding requirements for their design
and contents.
Selection of investigators and study
sites
The sponsor/CRO must go through a formal assess-
ment procedure before placement of a study. Some
of themost important areasrequiring assessmentare
described in Table 12.2. All studies involving
research of investigational medications and devices
require qualified investigators, and the internation-
ally accepted standard for ‘qualified’ usually
encompasses three main criteria: medically quali-
fied, that is legally licensed to practise medicine as a
physician; experienced in the relevant therapeutic
specialty; and experienced in clinical research.
Many contracts or agreements must be prepared,
understood and authorized before clinical studies
begin. The most common contracts include the
protocol and CRF; agreements for finances, con-
fidentiality, insurance and indemnity; and contracts
between the sponsor and the CRO. A separate
investigator agreement, specifying all responsi-
bilities, is usually necessary in addition to the pro-
tocol to emphasize certain aspects of the protocol.
Table 12.3 highlights some of the responsibilities
of the main investigator GCP which might be
included in contracts.12.3 Ethical considerations
Part of the selection process for a study site
involves confirming that ethics committee/IRB
review will be safe and that all study subjects will
be properly informed prior to consent to study
participation. If the sponsor/CRO cannot obtain
documented evidence of compliance with these
two fundamental requirements, it is not safe to
work with that site.Ethics committee/IRB review
Allclinicalstudiesrequirereviewbyanindependent
ethics committee/IRB before, during and after the
study. Before any study subject is treated, review by
the committee must be documented in compliance
with international guidelines and the local regula-
tions of the country in which the research is con-
ducted. Clinical studies begin (for the study
subjects) whenever the study subjects undertake
any procedure that they would not normally
undergo: ethics committee/IRB review must be
sought before these events. Thus, if a study requires
screening procedures, washout from normal treat-
ment and even completion of a questionnaire that
poses personal questions, the study begins when
those procedures are undertaken. It is a common
misconception that studies begin only when study
subjects are randomized to treatment.Table 12.2 Selection of study sites
The following items should be assessed at study sites by sponsor/CRO monitors before studies begin:
Study site personnel, for example qualification, experience, training, availability; specific allocation of
responsibilities
Facilities, for example offices, wards, archives, pharmacy, clinical laboratory; study medication/device storage
areas; clinical laboratories; access to source documents; ethics committee/IRB requirements
Suitable study subject population, for example access to suitable subjects in sufficient numbers; method of
subject recruitment; source, for example from investigator’s subject population, or be referred by other physicians and,
if referred, means by which investigator will obtain adequate evidence of medical history; use of advertisements;
potential subject enrolment (recruitment) rate
142 CH12 GOOD CLINICAL PRACTICES