ACRP PRACTICE EXAM 2022 QUESTIONS AND ANSWERS

[COMPANY NAME] [Company address] ACRP PRACTICE EXAM 2022 QUESTIONS AND ANSWERSA 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? - ANSWER 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 - ANSWER AST 130; ALT; 70; BUN 50; Create 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? - ANSWER 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? - ANSWER 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? - ANSWER 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? - ANSWER 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? - ANSWER 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 ACRP Practice Exam 2022 Questions and Answershome with him. According to ICH Guidelines, which are the best actions for the CRC to take initially? - ANSWER 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? - ANSWER 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 - ANSWER confidentiality agreement If the patient's weight is 123 lb, what is the weight in kg? - ANSWER 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? - ANSWER 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? - ANSWER $125 According to ICH guidelines, the source document should contain which of the following information regarding informed consent? - ANSWER 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? - ANSWER "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 thisinformation, the MOST appropriate sequence of action is to inform the: - ANSWER 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 - ANSWER 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 - ANSWER 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? - ANSWER 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 - ANSWER 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 - ANSWER 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 sponsor3. Send copies of the IP destruction forms to sponsor 4. Remove the drug accountability log from the material for sponsor. - ANSWER 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? - ANSWER 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: - ANSWER 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 - ANSWER 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? - ANSWER 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 - ANSWER 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? - ANSWER Remind the PI about inc/exc criteria Subjects in a prostate trial are required to undergo 4 chest xrays over a 4 week period. To ensure the subject understands safety issues, the IRB would be MOST concerned that the subject is informed of the: - ANSWER risks of the additional radiation At a screening visit, a CRC takes the following sitting BPs: 168/100 166/104 168/102 The patient's mean sitting diastolic BP is: - ANSWER 102 A clinical trial is being conducted to determine the safety and tolerability of a new anitemetic IP. The sponsor expects to enroll 20 subjects. This would be considered a: - ANSWER Phase I trial A clinical trial is being conducted for hormone replacement. This trial includes a diary. Which of the following would be considered an objective parameter out of these: mood swings, breast tenderness, severity of hot flashes, episodes of vaginal bleeding - ANSWER episodes of vaginal bleeding A PI has an enrollment goal of 24 subjects. Ten potential subjects are seen each week. Twenty percent of the potential subjects will not be interested in participating. 50% of the subjects who are interested will fail to meet one or more inc/exc criteria. How long will it take the CRC to fulfill enrollment? - ANSWER 6 weeks (10x 0.8= 8 subjects still interested.) (8 x 0.5= 4 subjects interested who meet criteria) 24 subjects goal/4 per week who qualify= 6 weeks to meet enrollment goal A subject is participating in a lipid-lowering clinical trial. Before the 12 month visit, the CRC receives and amendment from the sponsor , which includes the addition of quality of life measures to be collected at the 12 month visit. To ensure appropriate collection of of this additional data, the CRC should: - ANSWER Obtain the appropriate signature on the revise, approved consent form, THEN have the subject complete the questionnaire Which are the following are responsibilities of an IDMC/DSMB? 1. assess the financial aspects of a trial 2. assess the progress of a trial 3. recommend initiating a trial 4. recommend stopping a trial - ANSWER 2,4 - assess progress of a trial - recommend stopping a trialA CRC is screening subjects for an oral IP. All subjects must be stabilized on currently approved medications. Which of the following questions should be asked by the CRC? 1. When was the last time your medication dose changed? 2. Have you made any dietary changes in the past month? 3. When was your last chest xray and ECG? 4. Do you have any difficulty swallowing oral medication? - ANSWER 1,4 - when was the last time your med dose changed? - do you have difficulty swallowing oral medication A competent adult subject signs a consent form with an X and indicates approval. Which of the following is the BEST action for the CRC to take? - ANSWER Document why the subject signed with an X During the monitoring visit, a CRA discusses the following queries with the CRC: - Dates of subjects visits recorded as m/d/y instead of d/m/y - subjects' identification numbers are missing lead in zeroes - weights recorded in lbs instead of kgs - discrepancies in the two subjects' visit dates between source data and CRF entries. Which of the following actions should the CRC take? - ANSWER correct errors on CRFs as discovered In an effort to increase enrollment in an ongoing trial, the sponsor has broadened inc/exc criteria to increase the allowable creatinine level. The next step the CRC should take is to - ANSWER notify the IRB of the change A CRC calls a CRC to schedule the final monitoring visit. The sponsor requires the PI be present. The only dates available for the CRA conflict with the PI's schedule. To prepare for the visit, the CRC should: - ANSWER reschedule the visit During a respiratory trial, a subject calls the CRC 1 week before his next scheduled visit and reports upper respiratory symptoms and a pea-sized lump in his neck. Which of the following should the CRC do FIRST? - ANSWER Have the subject come to the site for an interim visit 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 2 additional doses. Which of the following represents a drug accountability issue? - ANSWER Subject B returns 12 pills after 8 days on the trial A subject is upset and wants to know whom she should contact regarding her rights as a research subject. The CRC should tell her to contact the: - ANSWER individual listed on the ICFIn addition to obtaining a signed ICF, which of the following should be documented in the research record? 1. The time and date that the procedures will be performed 2. that the subject's questions were answered 3. the names of people present during the consent process 4. that no trial procedures were performed prior to consenting. - ANSWER 2,4 - subjects questions were answered - no trial procedures performed prior to consenting A small biotech company is investigating the anti-tumoral potential of scorpion toxin in high grade recurrent brain tumors. After animal trials have been completed, the first trial in humans would most likely involve: 1. healthy volunteers 2. pharmacokinetic analysis 3. placebo control 4. dose escalation - ANSWER 2,4 - PK analysis - dose escalation A subject is participating in a lipid-lowering clinical trial. Before his 12m visit, the CRC receives and amendment from the sponsor that includes an outcomes measurement instrument at the 12m visit. The CRC should FIRST provide the subject with which of the following? - ANSWER a revise ICF A sponsor has supplied all sites with digital thermometers for a vaccine trial. At one site, the CRC notices that 10 of 30 subjects have recorded consistently low temperature readings in their diaries for the first 7 days of the trial. Upon review with the subjects, there were no related complaints. Which of the following should be the CRCs FIRST action? - ANSWER Notify the sponsor A subject is in a phase I oncology trial experiences nausea with vomiting after IP infusion which results in an inpatient hospitalization. Nausea with vomiting does not appear in the IB. The investigator should rate this event as - ANSWER unexpected and serious 26 subjects were enrolled in a pneumonia trial. The site received 100 bottles of IP. Each subject received 2 bottles. 4 subjects did not return their trial bottles. How many bottles are available for the CRC to return to sponsor at the end of the trial? - ANSWER 92 bottles At a trial site, CRCs perform quality assurance as needed throughout the progress of their trials. A CRC notes that 5 of the 7 research nurses failed to document subject understanding of the trial. Which of the following should the CRC perform? 1. inform the sponsor of this practice 2. revise the delegation of responsibility 3. ensure the subjects have been well-informed of the trial.4. review the informed consent process with the individual research nurses. - ANSWER3,4 - ensure the subjects have been well-informed - review ICF process with individual research nurses