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ACRP Practice Test|32 Questions and Answers
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- ACRP Practice Test|32 Questions And Answers
ACRP Practice Test|32 Questions and Answers
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ACRP Practice Test|32 Questions andAnswers
What are the liver function tests? (LFT) - -Liver function tests (also known as
a liver panel) are blood tests that measure different enzymes, proteins, and
other substances made by the liver.
* Albumin, a protein made in the liver
* Total protein, This test measures the total amount of protein in the blood.
* ALP (alkaline phosphatase), ALT (alanine transaminase), AST (aspartate
aminotransferase), and gamma-glutamyl transpeptidase (GGT) - These are
different enzymes made by the liver.
* Bilirubin, a waste product made by the liver.
* Lactate dehydrogenase (LD), an enzyme found in most of the body's cells.
LD is released into the blood when cells have been damaged by disease or
injury.
* Prothrombin time (PT), a protein involved in blood clotting.
-What are the thyroid function tests? (TFT) - -A thyroid panel is a group of
tests that may be ordered together to help evaluate thyroid gland function
and to help diagnose thyroid disorders.
* TSH (thyroid-stimulating hormone) - to test for hypothyroidism,
hyperthyroidism and to monitor treatment for a thyroid disorder
* Free T4 (thyroxine) - to test for hypothyroidism and hyperthyroidism; may
also be used to monitor treatment
* Free T3 or total T3 (triiodothyronine) - to test for hyperthyroidism; may also
be used to monitor treatment
-What order should a CRC inform the appropriate people when an SAE has
occurred? - -1. Study PI should be notified first as he/she is responsible for
the subject well-being while on the clinical trial and should assure that
adequate medical care is provided.
2. Sponsor, per ICH guidelines, all SAEs should be reported immediately
(within 24 hrs) to the study sponsor.
3. IRB/IEC, following applicable regulatory requirements for reporting SAEs
-When does the initiation visit occur? - -Once the site has received the
IRB/IEC approval letter
- any additional action needed regarding the initiation visit would occur after
status of approval letter is received
- The sponsor does not receive approval letters directly from the IRB/IEC
-Unexpected AE/SAE - -any event thought to be related to the
investigational product that is not listed in the Investigator's Brochure
, -What are Kidney Function Tests? - -kidneys filter and clean your blood,
taking out waste products and making urine. Kidney tests check to see how
well your kidneys are working. They include blood, urine, and imaging tests
* Glomerular filtration rate (GFR) - one of the most common blood tests to
check for chronic kidney disease. It tells how well your kidneys are filtering.
* Creatinine blood and urine tests - check the levels of creatinine, a waste
product that your kidneys remove from your blood
* Albumin urine test - checks for albumin, a protein that can pass into the
urine if the kidneys are damaged
* Imaging tests, such as an ultrasound - provide pictures of the kidneys. The
pictures help the health care provider see the size and shape of the kidneys,
and check for anything unusual.
* Kidney biopsy - a procedure that involves taking a small piece of kidney
tissue for examination with a microscope. It checks for the cause of kidney
disease and how damaged your kidneys are.
-What must occur prior to a subject signing the ICF? - -Subject must be
given ample time to review the document and have all questions answered.
Subject must sign the document prior to any study specific procedures
and/or test.
-According to ICH guidelines, what information should the source document
contain regarding the consent? - -Evidence that the consent form was
signed prior to trial related procedures.
-A clinical trial being conducted to confirm the safety and tolerability of a
new anti-emetic IP would be considered what phase of clinical study? - -
Phase I Trial
Phase I trials usually have non-therapeutic objectives
Are intended to determine the tolerability of dose ranges for future trials
Determine the nature of adverse events that may be expected
-To ensure subjects understand safety issues, the IRB/IEC would be most
concerned that the subjects are informed of what? - -Any additional risks
posed by study requirements (additional imaging, blood draws, ect.)
All associated risk/side effects of the investigational product, combination of
IP with current standard treatment, and current stand treatment associated
with the trial
-During a close out visit the following regulatory documents will be filed
and/or sent to the sponsor - -1. Treatment Decoding Documentation -
Sponsor retains this document
2. Drug Accountability Log - Kept at both the site and with the sponsor
3. Subject Identification Code List - Kept at the site in a confidential manner
4. Documentation of IP destruction - retained by the sponsor and kept at the
site if IP was destroyed at the site
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