the procedures for ordering bulk investigational
product supplies;
models for bulk investigational product quantity
estimation;
investigational product packaging time frames;
protocol-specific and country-specific require-
ments for packaging and shipping investiga-
tional product supplies;
procedures for packaging international investiga-
tional product supplies;
investigational product supply tracking systems;
investigational product ordering and packaging
processes;
general investigational product formulation and
packaging processes and configurations;
protocol design;
randomization procedures;
investigational product dispensing and account-
ability.
Identification and selection of clinical
investigators for study placement
and conducting pre-study evaluation visits
Selecting investigators: The proper selection of
clinical investigators is one of the key success fac-
tors for any clinical program. The investigator
(sometimes referred to as the principal investigator)
has the primary responsibility for the success of the
trial. His or her leadership and direction of sub-
investigators and study staff are critical in perform-
ing the requirements of today’s trials. Time spent in
learning who the best investigators are is well spent
and pays significant dividends in the end.
To successfully identify and select clinical
investigators, the sponsor’s representatives need
to identify internal and external sources of poten-
tial investigators, define investigator selection
criteria, protocol requirements, expected cost of
the study, investigator and facility qualifications,
interview potential investigators and, finally,
schedule and conduct pre-study site evaluation
visits.
The International Clinical Team (ICT) has an
important role in determining the quality selection
of clinical investigators. Selection criteria will
be based upon the needs of the CDP and the indi-
vidual protocols. Quality investigators can be
identified by
previous clinical research experience;
previous performance on sponsor and other
company trials;
their reputation among peers and the quality of
their publications;
the experience and training of their support staff;
the quality and reputation of their research
facilities.
Potential sources of quality investigators are
shown in Table 3.2.
Many physicians may need to be considered
before the best investigators can be identified.
Preliminary contact should be done by telephone.
Only those investigators who satisfy the primary
selection criteria need to be visited.
Pre-study visits: The purpose of the pre-study
visit is to evaluate the investigator’s interest and
ability to conduct the study to the required sponsor
Table 3.2 Sources of quality investigators
Clinical leaders/therapeutic area heads
Country company heads/medical directors
Consultants
Colleague recommendations
Investigator recommendations
Scientific and medical literature
Physician directories
Speakers at professional meetings
32 CH3 CLINICAL RESEARCH EDUCATION AND TRAINING FOR BIOPHARMACEUTICAL STAFF