standards. Normally, the monitor or CRA conducts
this. Special attention is paid to the quality of the
investigator’s staff and facilities, as well as to the
availability of the required patient population. In
conducting the pre-study site evaluation visit, the
sponsor’s representative determines whether or not
the investigator is qualified by training and experi-
ence to conduct the trial.
The pre-study visit is a professional exchange of
information. The investigator is informed of the
preclinical and clinical background of the drug. Of
primary importance to the investigator is the ratio-
nale for use of the drug and the expected safety
profile. Much can be inferred from the investiga-
tor’s preparation and questions about the investiga-
tional drug. The protocol should be explained,
including the requirements for the patient popula-
tion, the study design and a description of the safety
and efficacy variables.
Other aspects of the study are also discussed
with the investigator, such as the completion of
the CRF, access to source documents and manage-
ment of drug supplies. The nature and form of
informed consent are reviewed. In these discus-
sions, the sponsor’s representative is attempting
to identify aspects of the study that present diffi-
culties or problems for the investigator. Quality
investigators usually have clear understanding
and strategy for the above activities. Examples of
the questions that require answering during pre-
study visits are shown in Table 3.3.
Some objective measure of the availability of the
correct patient population is important during a
pre-study visit. The sponsor’s representative can
often best accomplish this through a chart or hos-
pital census review.
The time spent doing this aspect of a clinical trial
will invariably result in better and more timely
results in clinical programs.
Assuming that the outcome of the pre-study
visit(s) is successful, the sponsor’s representative
will need to develop and negotiate study contracts
and secure essential documents.Competencies associated with
conducting clinical researchInvestigator meetingSponsors now try to conduct many initiation activ-
ities via an investigator meeting. Such meetings
(which may be in person or utilize videoconferen-
cing or internet technology) can be used to orient
all investigators to the fundamental practical
requirements of the protocol and trial (CRF com-
pletion, investigational product handling, discus-
sion of audits/inspections, etc.). These meetings
provide an opportunity to ensure common under-
standing of issues, subjective grading systems and
so on. However, investigator meetings tend not to
be attended by all the staff who will be involved in
the conduct of the trial at the institution. Inevitably,
this means that the sponsor’s representative has to
conduct study initiation activities at the institution
with some key staff.Conducting study initiationThe study initiation visit is sometimes confused
with the pre-study visit. The purpose of the study
initiation visit is to orient the study staff (sub-
investigators, study coordinators, etc.) to the
requirements of the protocol. At the point of the
study initiation visit, the study site should be fully
ready to begin all aspects of the trial. The monitor
must ensure that the study medication and materi-
als are available at the site. In addition, all essential
documentation must be completed and available.
Key study documentation is shown in Table 3.4.
All study staff who will have direct involvement
in the trial should participate in the study initiation
visit or investigator meeting. This usually includesTable 3.3 Pre-study visit questions
How will the protocol specifically operate at the
prospective center?
How will informed consent be obtained? By
whom?
How will source documents be managed?
How will adverse events be handled and followed up?
Serious and nonserious events?
How many studies is the investigator conducting
currently?
3.3 COMPETENCY-BASED TRAINING PROGRAM FOR STAFF ASSOCIATED WITH CONDUCTING CLINICAL TRIALS 33