geographically separated areas in the country, and
researchers may not inform the local IRB.
Normally, the sponsor/CRO will prepare all
necessary documentation for submission by the
investigator to the ethics committee/IRB (it is not
usual procedure for the sponsor/CRO to directly
submit items to the committee, unless requested to
do so by the committee). Whatever the local varia-
tions, the sponsor/CRO is usually responsible for
ensuring the submission of the items in Table 12.4.
Some committees require other additional items.
The membership of an ethics committee/IRB
will vary nationally and regionally. However, the
sponsor/CRO is only permitted to conduct studies
that are approved by ethics committees/IRBs that
have a sufficient number of qualified members to
enable a medical and scientific review of the pro-
posed study and a review of all other ethical aspects
of the study. Generally, ethics committees also
have to be diverse in composition. Details of the
membership of the ethics committee/IRB should
be obtained and reviewed by the sponsor/CRO,
prior to initiating the study, to ascertain the above
and to determine that there is no serious conflict of
interest (e.g. investigator voting on her/his study).
The sponsor/CRO should also request a written
copy of the working procedures of the ethics
committees/IRBs. These procedures should pro-
vide sufficient information to assure sponsors/
CROs, investigators, auditors and inspectors of
the integrity and independence of the ethics
committee/IRB. Unfortunately, today, it is still
difficult to obtain working procedures from many
committees.
Ethics committees/IRBs also have responsibi-
lity for review during and after clinical studies
(Table 12.5). In other words, committee review is
an ongoing responsibility that extends beyond the
initial submission and review of documents to
proceed with the study.
Informed consent
Potential study subjects may enter a clinical study
conducted by the sponsor/CRO only after being
properly informed and consenting to participate.
The researchers must consider who does what,
when, what sort of information must be provided
and how this will all be documented. The general
principles for the conduct of informed consent are
noted in Table 12.6 (see also Chapter 7). All infor-
mation sheets and consent forms should include the
items listed in Table 12.7, and they must be pro-
vided before study participation. Obtaining
informed consent is a complex issue, and it is not
easy to comply with these requirements.12.4 Monitoring and safety
assessmentThe conduct of clinical studies is a cooperative
undertaking between the sponsor/CRO and the
investigator; each is responsible for ensuring that
the study is in conformity with the protocol and in
accordance with all applicable laws and regula-
tions, and, of course, that study subjects are pro-
tected at all times. This responsibility involves
regular and conscientious review of the progress
of the study by the sponsor/CRO and by the inves-
tigator and study site personnel.Monitoring
One of the most important means of quality control
of a clinical study is managed by frequent and
thorough monitoring. A monitor’s aim is first to
protect the agenda of the sponsor/CRO who
employs him/her. Monitors (often referred to as
CRAs or Clinical Research Associates or Assis-
tants in the pharmaceutical industry) must ensure
maintenance of proper standards, compliance with
the protocol, accurate and complete data capture
and standardization across sites in a multicenter
study. Basically, monitors will undertake the
review noted in Table 12.8.
In general, study sites should be visited by a
monitor at least every four to six weeks. The fre-
quency of monitoring visits will be defined for each
individual study and will depend on details such as
the study phase, treatment interval and overall
duration, enrolment rate, complexity of the study
methodology, occurrence of adverse events (AEs)
or other significant events, and the nature of the144 CH12 GOOD CLINICAL PRACTICES