Clinical Research Professional Certification Preparation And Good Clinical Practice (GCP) Review Course

A collection of vocabulary flashcards based on the concepts covered in a clinical research course, focusing on ethical practices, regulations, and essential terms in clinical research.

Good Clinical Practice (GCP)

An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.

Informed Consent

A process by which a subject voluntarily confirms their willingness to participate in a study after being informed of all relevant aspects of the trial.

Nuremberg Code

A set of research ethics principles developed in 1947 that states the voluntary consent of human subjects is absolutely essential.

Belmont Report

A report that outlines the ethical principles and guidelines for research involving human subjects, emphasizing respect for persons, beneficence, and justice.

Investigational New Drug (IND) Application

A request for authorization from the FDA to administer an investigational drug to humans.

Clinical Trial Phases

Different stages of clinical research: Phase I assesses safety, Phase II focuses on efficacy and side effects, Phase III confirms effectiveness in larger populations.

Institutional Review Board (IRB)

A committee that reviews and monitors biomedical research involving human subjects to ensure their rights and welfare are protected.

Adverse Event (AE)

Any untoward medical occurrence associated with the use of a drug in humans, whether or not drug-related.

Serious Adverse Event (SAE)

An adverse event that results in death, is life-threatening, requires hospitalization, or causes significant disability.

Clinical Holds

An order issued by the FDA to delay a proposed clinical investigation or to suspend an ongoing investigation when human subjects may be at risk.