– An expected or unexpected occurrence that may or may not be related to the clinical trial drug or device.
– Doing no harm, maximizing benefits while minimizing risks.
– Study of drug, biologic or device in human subjects with the intent to discover potential beneficial effects and/or determine its safety and efficacy.
– Contains all relevant study information explained in lay terms and documents the voluntary participation of a subject. Presented to and signed by the subject.
Declaration of Helsinki
– Statement of ethical principles first published by the World Medical Association in 1967 to define rules for therapeutic and non-therapeutic research.
Good clinical practice
– International ethical and scientific quality standard for designing, conducting, monitoring, recording, auditing, analyzing and reporting studies. Ensures that the data reported is credible and accurate and that the subject’s rights and confidentiality are protected.
– A list of criteria that must be met by all study subjects.
– Information exchange including subject recruitment materials, verbal instructions, written materials, questions and answer sessions, and signature documenting consent with date. Subjects are given the opportunity to choose involvement based on information, comprehension and voluntariness.
– Location of research. Retains ultimate responsibility for human subject regulation compliance.
Institutional review board
– Reviews research and consent forms to determine if rights and welfare of subjects are protected.
– Conducts and directs study. Carries ultimate responsibility for research. Is referred to as the principle investigator when acting as the leader for an investigational team. Also referred to as clinical investigator by the FDA.
Patient oriented research
– Research conducted with human subjects (or on material of human origin) in which an investigator or colleague directly interacts with human subjects.
– Documentation of study objective, design, methods, statistical methods and organization. The term also includes amendments made to the original document.
– Changes or clarifications made in writing to the original protocol.
– Risk to individual subject vs. potential benefits. Also called risk-benefit analysis.
Serious adverse event
– Any event that results in death, a life-threatening situation, hospitalization or prolonged hospitalization, disability, incapacity or a congenital anomaly/birth defect.
Standard operating procedure
– Detailed, written procedures for the uniform performance of a function.
– Group/individual that cannot give informed consent because of limited autonomy (e.g., children, mentally ill and prisoners). Also refers to subjects who may be unduly influenced to participate (e.g., students, subordinates and patients).