ACRP Practice Test – Safety Reporting, SAE Management,
and Clinical Laboratory Assessments with Verified
Solutions
Description:
This practice exam provides verified ACRP test questions and answers, focusing on
SAE reporting, ICH guidelines, and subject protection. It also includes detailed
coverage of clinical laboratory assessments such as liver, kidney, and thyroid
function tests, with interpretation of results. Designed as an updated review tool, it
ensures candidates are prepared for both ethical and technical aspects of clinical
trial management.
What are the liver function tests? (LFT) - answer✔✔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
1
liver. * Bilirubin, a waste product made by the liver. * Lactate dehydrogenase (LD), an
Page
, 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) - answer✔✔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? - answer✔✔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? - answer✔✔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 -
answer✔✔any event thought to be related to the investigational product that is
not listed in the Investigator's Brochure What are Kidney Function Tests? -
answer✔✔kidneys filter and clean your blood, taking out waste products and
2
Page
making urine. Kidney tests check to see how well your kidneys are working. They
and Clinical Laboratory Assessments with Verified
Solutions
Description:
This practice exam provides verified ACRP test questions and answers, focusing on
SAE reporting, ICH guidelines, and subject protection. It also includes detailed
coverage of clinical laboratory assessments such as liver, kidney, and thyroid
function tests, with interpretation of results. Designed as an updated review tool, it
ensures candidates are prepared for both ethical and technical aspects of clinical
trial management.
What are the liver function tests? (LFT) - answer✔✔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
1
liver. * Bilirubin, a waste product made by the liver. * Lactate dehydrogenase (LD), an
Page
, 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) - answer✔✔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? - answer✔✔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? - answer✔✔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 -
answer✔✔any event thought to be related to the investigational product that is
not listed in the Investigator's Brochure What are Kidney Function Tests? -
answer✔✔kidneys filter and clean your blood, taking out waste products and
2
Page
making urine. Kidney tests check to see how well your kidneys are working. They
