ACRP PRACTICE TEST 2023 WITH
UPDATED CORRECT ANSWERS 2024
1. 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 amino-transferase), 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.
2. 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
3. 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
4. When does the initiation visit occur?: Once the site has received the IRB/IEC approval letter
1/6
, ACRP PRACTICE TEST 2023 WITH
UPDATED CORRECT ANSWERS 2024
- 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
5. Unexpected AE/SAE: any event thought to be related to the investigational product that is not
listed in the Investigator's Brochure
6. 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.
7. 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.
8. 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.
9. 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
2/6
UPDATED CORRECT ANSWERS 2024
1. 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 amino-transferase), 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.
2. 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
3. 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
4. When does the initiation visit occur?: Once the site has received the IRB/IEC approval letter
1/6
, ACRP PRACTICE TEST 2023 WITH
UPDATED CORRECT ANSWERS 2024
- 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
5. Unexpected AE/SAE: any event thought to be related to the investigational product that is not
listed in the Investigator's Brochure
6. 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.
7. 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.
8. 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.
9. 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
2/6
