ACRP Practice Test | 100% Correct
Answers | Verified | Latest 2024 Version
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
Answers | Verified | Latest 2024 Version
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
