INTRODUCTION
Regulatory authorities such as the FDA aim to ensure the safety and efficacy of drugs, biological products,
and medical devices by overseeing all aspects of a clinical trial during its lifecycle.
DEFINITIONS
GOOD CLINICAL PRACTICE (GCP):
“A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and
reporting of clinical trials that provides assurance that the data and reported results are credible and
accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.”1
PROTOCOL:
“A document that describes the objective(s), design, methodology, statistical considerations, and
organization of a trial.”1
STATISTICAL ANALYSIS PLAN (SAP):
“A document that contains a more technical and detailed elaboration of the principal features of
the analysis described in the protocol and includes detailed procedures for executing the statistical
analysis of the primary and secondary variables and other data.”2
TRIAL COMPLIANCE:
“Adherence to all the trial-related requirements, GCP requirements, and the applicable regulatory
requirements.”1
DSMB/IDMC:
Data Safety Monitoring Board / Independent Data Monitoring Committee. An independent group of
therapeutic experts and a biostatistician not otherwise involved in the conduct of a trial who monitor
accumulating safety data from a clinical trial in order to help ensure the safety of study participants.
2