Abstract
Quality assurance is important in the development and conduct of a successful single-site
clinical trial. The successful principal investigator (PI) is one who aligns him/herself
with a knowledgeable team with demonstrated capabilities in all aspects of clinical
trial design and execution including professionals with expertise in biostatistics
and experimental design, research administration including budget preparation and
proposal submission, patient recruitment and contact, data collection, data analysis,
and computers. The effective PI will become an effective coordinator of these functions
by assembling this team, establishing a realistic schedule, and demonstrating enthusiasm,
integrity, and leadership. The team, as it is being assembled, and which typically
includes nonphysicians, will find helpful an explicitly enlarged, detailed statement
of the proposed hypothesis. This statement may include the type of patients to be
studied, duration of the proposed observation period, and the methods of evaluation.
Careful planning is the best assurance that a successful and worthwhile study will
be accomplished.
Key Words:
clinical trial - quality assurance - experimental design
