Clinical research refers to systemic investigation in a human being for evaluating the safety and
efficacy of a new drug. As various diseases are increasing day producing threat to human being
and treatments available to treat them are limited, the necessity for new drug development has
amplified.
History of Clinical Trial Process and Development of GCP
Many of the drugs that are used today have been discovered in the past by research and trialand-
error activities with different structured. Thus, we can say that, research and the trial is a
root cause of modern medicine: In fact, clinical trial is key link between mankind and life saving
medicines and it has given number of effective medicines to the society. Few important events
and incidences from the past have constituted the pillars of today’s drug development system.
Similarly, number of other events has also helped for the improvement in Good Clinical practice
(GCP) standard for conduct of clinical trials.
Clinical trial is a very important step in drug development process as it deals with human
beings. Hence, it is necessary to understand the basic terminologies; as these terminologies have
regular application in clinical trials. The following glossary was prepared to help the consumer
become familiar with many of the common terms used in clinical trials.
The successful execution of a clinical trial means the project is finished on time, on
budget and has a high level of quality. It only figures that these objectives would be possible to
achieve only when trial has an effective and robust team. This team not only includes the
individual/[s] those who are part of group during the conduct of trial but also involvement of
people from organizing the trial till marketing the drug.
