ACRP Practice Test
What are the liver function tests? (LFT) - ANSLiver 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) - ANSA 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? -
ANS1. 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? - ANSOnce 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 - ANSany event thought to be related to the investigational product that
is not listed in the Investigator's Brochure
What are Kidney Function Tests? - ANSkidneys 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
What are the liver function tests? (LFT) - ANSLiver 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) - ANSA 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? -
ANS1. 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? - ANSOnce 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 - ANSany event thought to be related to the investigational product that
is not listed in the Investigator's Brochure
What are Kidney Function Tests? - ANSkidneys 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
