1. What is GCP?
Good Clinical Research Practice (GCP) is a process that incorporates established ethical and scientific quality standards for the design, conduct, recording and reporting of clinical research involving the participation of human subjects. To ensure Rights, Safety, and Wellbeing of trial subjects are protected.
2. What is Adverse Event?
Adverse Event Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
3. What is Adverse Drug Reaction?
A response which is noxious and unintended, and which occurs at doses normally used in humans for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function.
4. What is Serious Adverse Event (SAE)?
• An adverse event is any undesirable experience associated with the use of a medical product in a patient.
• Any AE which falls under 5 criteria are considered as
SAE. They are
1. Death.
2. Life threatening.
3. Requires hospitalization or prolongation of an existing hospitalization.
4. Congenital anomaly/Birth defects.
5. Persistent disability.
5. What is SUSAR?
Suspected unexpected serious adverse reaction is an untoward and unintended response to a study drug, which is not listed is the applicable product information, and meets one of the following serious criteria: results in death, life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability, or is a congenital anomaly or birth defect.
What is GCP? & Adverse Drug Reaction in clinical research
