GOOD CLINICAL PRACTICE MODULE 2:QUESTIONS & CORRECT DETAILED ANSWERS LATEST UPDATE

GOOD CLINICAL PRACTICE MODULE 2:QUESTIONS &
CORRECT DETAILED ANSWERS LATEST UPDATE


1. · Define clinical - Clinical trials (also known as clinical study or clinical research) is a research study
trials and a basic using human subjects.
overview of the - Types of clinical trials:
types of clinical - Observational
trials - Interventional
- Retrospective
- Prospective
- Prevention
- Screening
- Diagnostic
- Treatment
- Quality of life

2. · Explain the pur- - The purpose of clinical trials:
pose of clinical - From a scientific perspective, well-conducted clinical trials are the safest and
trials fastest way to find treatments that work in people and new ways to improve health
From a business perspective, clinical trials may be required before a national
regulatory authority, such as FDA, approves the marketing of a new drug

3. Explain the objec- - The objectives of clinical trials
tives of clinical tri- - To ascertain the safety and eflcacy of the investigational product.
als

5. · Define GCP
4. · Describe
the fundamental
principles of clin-
ical research to-
day

, GOOD CLINICAL PRACTICE MODULE 2:QUESTIONS &
CORRECT DETAILED ANSWERS LATEST UPDATE


Safety and eflcacy are
determined by identifying or
verifying the clinical, pharma-
cological, pharmacodynamic,
pharmacokinetic, and adverse
ettects of a drug

1. Protection of human
subjects: the rights,
safety, and well-being of
people participating in
a clinical trial is of the
highest concern

2. The scientific approach:
must be used in the design and
analysis of clinical trials. All
clinical trials should be
designed, conducted, and
analyzed according to sound
scientific methods so that
their objectives may be
achieved, and they should be
reported appropriately.