ACRP Practice Exam questions and answers

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 compliant is he? 50% To be eligible for a trial, the subjects must have liver function tests no greater than two times the upper limit normal and rental function tests no greater than three times the upper limit normal. All of the following are normal ranges for the trial: AST 5-65 ALT 5-35 BUN 4-25 Creat 0.5-1.2 Amylase 56-190 Lipase 4-24 ALK Phos 0-110 AST 130; ALT; 70; BUN 50; Creat 2.4 A subject presents at a site with her husband after pre-qualifying on a phone screen. She states that she is legally blind and cannot read the ICF. A Braille ICF is not available. This subject is able to sign her name if her hand is guided to the signature line. Which of the following is the BEST course of action to obtain legal consent from the subject? The subject and an impartial witness can sign the ICF after it is read to them and she verbally states her understanding. Which of the following is MOST useful for scheduling trial procedures? trial schedule of events A subject is participating in a clinical trial where only the pharmacist and sponsor knows the identity of the IP. The pharmacist has no contact with the trial subject and the clinical team. Which of the following BEST describes this trial type? double blind A site has not received IRB/IEC approval for a protocol submission. The PI instructs the CRC employed by the clinic to begin scheduling subjects for screening appointments. Which of the following is the BEST course of action for the CRC to take? Review the research database and collate a list of potential subjects The trough blood level for once daily drug should be drawn how long after the last dose? 24 hours A potential subject for a trial has been mailed an ICF prior to his screening visit. When the subject arrives at the research dept for his screening visit, he states he read the ICF and is ready to do the trial. He does not have a copy of the ICF that was mailed to his home with him. According to ICH Guidelines, which are the best actions for the CRC to take initially? Have the subject sign the ICF Confirm the subject's understanding of the ICF A CRC is enrolling three subjects for a Phase III trial with restrictive eligibility criteria. The PI indicates that she must leave the office to teach a lecture in 30 minutes. The lab will be closing in 1 hour. Which of the following is the MOST appropriate action for the CRC? Give each subject sufficient time to review the ICF All of the following are regulatory documents except: informed consent protocol signature page lab certification confidentiality agreement confidentiality agreement If the patient's weight is 123 lb, what is the weight in kg? 56 A CRA calls to schedule a close-out visit. Per sponsor SOPs, the PI must be present. The CRC informs the CRA That the PI will be out of the country during the period when the CRA would like to visit. The CRC should do which of the following? Reschedule the close-out visit for a later date The CRC reviewed a new protocol to prepare the trial budget for submission to the sponsor. According to the protocol, each subject is to return for follow up visits at 30 days, 60 months and 1 year. At 30 days, protocol requires a physical exam, an ECG and chest xray At 6 months, physical and ECG At 1 year, physical, ECG and chest xray The hospital charges $75 for the physical exam, $50 for the ECG and $100 for chest xray. The 30day and 1year visits are SOC for the subjects. How much should the CRC budget for the non-SOC visits? $125 According to ICH guidelines, the source document should contain which of the following information regarding informed consent? Evidence that the consent form was signed prior to trial related procedures A subject has signed the informed consent form for a hypertenstion trial. All screening procedures and the physical examination have been completed. The CRC is ready to dispense the single-blind placebo to the subject who asks "Is that the sugar pill I read about in that form I signed?" Which of the following should the CRC tell the subject? "It might be placebo, but we will be checking your blood pressure every week" At the month 3 visit of a Phase III double-blind trial, the subject informs the CRC that he was seen in the emergency department for an anaphylactic reaction. The subject states "The doctor told me i was very lucky. I might have died". Having received this information, the MOST appropriate sequence of action is to inform the: PI, sponsor and IRB Which of the following scenarios are considered SAEs? 1. infection following surgery prolonging hospital stay. 2. pregnancy resulting in normal delivery of twins 3. boating accident with overnight hospital stay 4. use of illicit drug during trial Infection following surgery, prolonging hospitalization Boating accident with overnight hospitalization A subject is admitted to the hospital for chest pain and suspected myocardial infarction. This subject gave informed consent for a trial of a new antihistamine 1 week before the onset of any chest pain. The subject took the first dose of the test article 2 days ago. The PI determines the event is probably related to the IP. Which of the following is the BEST course of action for the CRC to take Notify the sponsor that the PI believes the event is related to the IP Which of the following would require prior consent when screening a subject? Washout from medication The protocol and protocol summary have been submitted to a central IRB/IEC for review/approval by the CRO prior to the investigator's meeting. Following the meeting, the entry criteria are altered to facilitate the recruitment and retention of eligible subjects. Prior to trial start up, the regulatory binder must include: 1. an IRB letter of approval for the amended protocol 2. an IRB site evaluation form 3. the amended protocol 4. the investigator's brochure 1,3,4 IRB letter of approval for amendment amended protocol IB Which of the following is a liver function test? TSH LDH BUN Hct LDH A CRA is conducting a close-out visit at a site to review the regulatory documents. The CRC has prepared the following documents to be filed and/or sent to the sponsor: treatment decoding documentation, drug accountability log, subject identification code list, documentation of IP destruction and final report to IRB. Which of the following actions should the CRC perform? 1. Send the treatment decoding documentation to sponsor 2. Remove the subject identification code list from the material to be sent to sponsor 3. Send copies of the IP destruction forms to sponsor 4. Remove the drug accountability log from the material for sponsor. 1,2,3 -Send treatment decoding documentation to sponsor -Remove identification code list from material to be sent to sponsor -send copies of IP destruction forms to sponsor The day before a CRA is to conduct an initiation visit, the CRC realizes that the IRB approval letter has not yet been obtained. Which of the following should the CRC do FIRST? Call the IRB to check the status of the letter A hypertension trial protocol indicates that subjects should not be randomized on Fridays or Saturdays. During subject screening, a subject meeting all entry criteria is identified. However the only day that the subject is available for clinic visits is Friday due to his work schedule. The CRC should: Contact the sponsor regarding the subject's time conflict A sponsor/investigator (investigator initiated research) expands a trial from a single site to 4 trial sites in different areas of the country. The sponsor/investigator should do which of the following? 1. Monitor compliance with GCP 2. Report AEs to the sites 3. Keep investigators informed of new findings 4. Update investigators regarding subject recruitment 1,3 -Monitor compliance with GCP - Keep investigators informed of new findings A subject is being screened for an allergic rhinitis trial. At the screening visit, the CRC obtains a BP of 200/100mmHg. The subject states she has not had a problem with hypertension and does not take HTN medication. The CRC checks the inc/exc criteria section of protocol and does not find HTN to be an exclusion criterion. What would be the next step for the CRC? Recheck the BP A CRC has received three subject complaints of localized infection at the venipuncture site. The CRC queries the phlebotomist and discovers when the first stick is unsuccessful, any additional sticks are done with the same needle. This is in violation of the site's SOPs. Which of the following actions should the CRC take? 1. Suggest review of proper specimen collection for the phlebotomist 2. Document and report findings 3. Inform the IRB of the situation and corrective action 4. Report the incidents to the IDMC/DSMB 1,2 -Suggest review of proper specimen collection to phlebotomist -Document and report findings To qualify for a sinusitis trial, subjects must have a positive sinus xray (defined by >3mm of mucosal thickening) and a history of 2 episodes of sinusitis treated with antibiotics within the past year. Subjects allergic to penicillin are excluded. The PI has identified a potential subject. On further questioning, it is discovered the subject only had one previous episode of sinusitis that was treated with an antibiotic. The PI insists the subject would be perfect for the trial. Which of the following is the FIRST course of action? Remind the PI about inc/exc criteria