ACRP CCRC Practice Questions Answered 100% Correct

1. A subject is issued 120 tablets and is instructed to take 2 tablets 4 times a day. He returns 88 tablets on the morning of day 9 fasting for laboratory tests. What percent compliance is he? A. 50% B. 64% C. 78% D. 100% - ANSWER-1. Answer: A - Math Calculation: 120 = # dispensed, 120-88 (# returned) = 32 (# actually taken), 8 days X 8 tablets per day =64 (# that should have been taken, 32 (# taken)/64 (# should have been taken) = .5 or 50% compliance 1. Twenty-six subjects were enrolled in a pneumonia trial. The site received 100 bottles of IP. Each subject received two bottles. Four subjects did not return their trial bottles. How many bottles are available for the CRC to return to the sponsor at the end of the trial? A. 44 B. 48 C. 92 D. 96 - ANSWER-1. Answer: C - Math Calculations: 100 (in stock) - (4 patients x 2 bottles each) = 92 1. The DSMB has prematurely terminated a trial evaluating an investigational pain medication that is taken one caplet orally b.i.d for chronic hip pain. Subjects are allowed to take one extra caplet per day. Subjects receive a sufficient quantity of IP for 14 days plus two additional doses. Which of the following represents a drug accountability issue? A. Subject A returns 24 pills after 10 days on the trial B. Subject B returns 12 pills after 8 days on the trial C. Subject C returns 29 pills after 5 days on the trial D. Subject D returns 42 pills after 1 day on the trial - ANSWER-1. Answer: B - References: E6 4.63 - Math Calculations: Amount dispensed = 14 days x 3 pills = 42 + 3 additional doses = 44. Subjects can take either 2 or 3 days per day - A is incorrect - 10 days x 2 days = 20; 44-20=24 - B is correct if subject took 2 pills a day, then 8x2=16; 44-16=28; If subject took 3 pills a day then 8x3=24 and 44-24=20. Either way, 12 pills is too few to return. - C is correct 5x3=15; 44-15=29 - D is incorrect 1x2=x; 44-2=42 1. A small biotech company is investigating the anti-tumoral potential of scorpion toxin in high grade recurrent brain tumors. After animal trials have been complete, the first trial in humans would MOST likely involve (Pick all relevant groups) 1. Healthy volunteers 2. Pharmacokinetic analysis 3. Placebo control 4. Dose escalation A. 1 and 3 only B. 1 and 4 only C. 2 and 3 only D. 2 and 4 only - ANSWER-1. Answer: D - Reference E8 3.1.3.1 - 1 is incorrect - Phase I trials may be done in healthy volunteers AND certain types of patients (they are NOT always limited to healthy volunteers.) - 2 is correct Phase I trials are primarily involved with PK sample - 3 is incorrect Phase I may or may not use a placebo control, however, it would not be ethical in a recurrent brain tumor study - 4 is correct Dose escalations are primarily done in Phase I trials. - D is correct since it is the only option that contains both 2 and 4 1. If the patient's weight is 123 lbs, what is the weight in kg? A. 31 B. 48 C. 56 D. 271 - ANSWER-1. Answer: C - Math Calculations: Conversion - 1 lb. = 4536 kg. 123 x 4536 = 55.8 kg. Rounded up = 56 kg 1. In an effort to increase enrollment in an ongoing trial, the sponsor has broadened inclusion/exclusion criteria to increase the allowable creatinine level. The next step the CRC should take is to: A. Notify the IRB/IEC of the change B. Revise the ICF C. Contact previously ineligible patients D. Document the change in existing subject' CRFs - ANSWER-1. Answer: A - References: E6 4.5.2 - A is correct - prior to implementing any changes to the protocol, the investigator should notify the IRB/IEC - B is incorrect because the ICF may or may not need to be changed; this would be subsequent to notifying the IRB/IEC - C is incorrect since there is no indication that this should be done and would not be the first action. No subjects could be contacted until the protocol change was approved. - D is incorrect because there is no reason to do this; the change to the protocol does not affect the inclusion of current subjects