The document outlines key concepts in clinical research, including Good Clinical Practice (GCP), adverse events, adverse drug reactions, serious adverse events, and suspected unexpected serious adverse reactions (SUSAR). GCP involves ethical and scientific standards to ensure the safety and well-being of research subjects. Definitions and criteria for various adverse events are provided to understand their implications in clinical studies.

1. Interview Preparation Questions
CLINICAL RESEARCH
PART-1

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What is Good Clinical Practice (GCP)?
What is Adverse Event?
What is Adverse Drug Reaction?
What is serious adverse event?
What is Suspected Unexpected
Serious Adverse Reaction (SUSAR)?
INDEX

3. 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 Well-being of trial
subjects are protected.

4. 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

5. 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.

6. 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

7. 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.

9. Acheivements-2023