Test
CRC Exam Pre-test 2005
Crea una cuenta gratis para terminar este test
Guarda tu progreso y consulta tu resultado final.
¿Ya tienes cuenta? Inicia sesión
Preguntas del test (80)
1Who is responsible for writing and filing the IND safety report to the regulatory authority?
- Ainvestigator
- Bsponsor
- CIRb/IEC
- Dstudy coordinaor
2The CRC decides that she should create a telephone call worksheet to capture events between the in-person study visits. She identifies the times to obtain and decides that she should also share this infomation with the PI. Which of the events are the most important to share with the PI?
- Aconfirmation of date of next study visit, compliance in taking the test article and visits to the primary physicians
- Breports of major medical events and visits to primary care physicians
- Cconfirmation of date of next study visit, reports of major medical events and changes in concomitant medications
- Dcompliance in taking the test article and changes in concomitant medications
3the investigator must notify the IRB/IEC of an significant new findings during the course of the study when the _________
- Ainvestigator has notified all subjects
- Bfinal report is submitted to the sponsor
- Cinformation becomes available to the investigator
- Dsponsor submits the final report to the FDA
- Ainvestigator has notified all subjects
4When a subject reports an adverse event, who is responsible for determining its "relationship to the study drug"?
- ACRA
- BIRB/IEC
- CInvestigator
- DCRC
5A CRA is responsible for which of the following?
- Areviewing charts for potential subjects
- Bnotifying the FDA of any AE's
- Cassessing the performance of the investigator
- Dpreparing the application for IRB/IEC submission
6A site institution is involved in a clinical trial involving emergency research of a potentially life-saving device. A subject arrives unconscious at the ER following major trauma and meets the eligibility criteria of the aforementioned trial. Who has the authority under these circumstances to waive the informed consent requirements so that this subject may be enrolled in the trail?
- Athe investigator and a physician associated with the IRB/IEC
- Bthe investigator and a sponsor representative
- Cthe subject cannot enroll as such waivers are not allowed
- Dthe investigator and an independent physician
7At the final visit, the CRC discovers that a subject has not been taking the test article as directed. However, according to the pill counts conducted throughout the study, the subject appeared to be compliant. What should the CRC do in this situation?
- AClassify the subject as dropped from the date at which the noncompliance began
- BReport the subject's noncompliance to MedWatch using Form 3500A
- CRecalculate compliance for each visit to determine a more accurate compliance percentage based on the subject's verbal account
- DDocument the available information surrounding the noncompliance in the CRF
8When advertising for research subjects in a local newspaper, which of the following are most appropriate to be included?
- Apossible benefits of participation, including improvement in disease
- Brequired age, gender, and diagnosis of eligible subjects
- Cname of the sponsor
- Dname of the study drug
9under certain circumstances it may be necessary to disclose Protected Health Information (PHI) without prior written permission of the subject. Those circumstances would be
- Ainsurance company requests
- Bfamily member inquiries
- Cnon existant
- Dmedical emergencies
10After signing a consent form for a double-blind placebo-controleld study, the subject says, "i know this medicine willcure me". this statement may indicate
- Athe subject wants access to the drug withotg participating as a subject in the study
- Bthe subject may have signed the informed consent form under duress
- Cthe subject does not fully understand the study
- Dthe subject is of the impression that this study involves a marketed drug
11A subject who intentionally overdosed is treated in the emergency dept and released after 22 hours of observation. Per ICH guidelines, what would the CRC be required to do?
- ANotify the sponsor within 24 hours
- BNotify the IRB/IEC immediately
- CDocument as an AE
- DDocument as an SAE
12According to ICH guidelines, an adult who is illiterate may be considered as a subject for a clinical study under which of the following circumstances?
- Awith an impartial witness signature on the informed consent
- Bprovided the subjects legal representative witnesses the informed consent
- Cunder no circumstances
- Dif the subject can understand the oral consent and sign with an x
13 A CRF requires metric documentation of height and weight. A subject weighs 150 lbs and is 5 feet 5 inches tall. Which of the following would the CRC document in the CRF?
- A68 kg and 165 cm
- B60 kg and 143 cm
- C72 kg and 170 cm
- D75 kg and 180 cm
14A site has been participating in a long-term study for 11 months. In preparation for an upcoming interim-monitoring visit, the CRC reviews the regulatory document binder to identify any outstanding issues in this area. For such a review, which of the following is the most important regulatory document for the CRC to examine?
- Afinancial disclosure updates
- Bscreening logs
- CFDA Form 1572
- DIRB/IEC approval
15A site has been participating in a long-term study for 11 months. In preparation for an upcoming interim-monitoring visit, the CRC reviews the regulatory document binder to identify any outstanding issues in this area. For such a review, which of the following is the most important regulatory document for the CRC to examine?
- Afinancial disclosure updates
- Bscreening logs
- CFDA Form 1572
- DIRB/IEC approval
16A subjects study-specific flow sheet should be stored with
- Amedical records
- Bregulatory docs
- Cdrug accountablity
- Dsource documents
17Which of the following is a BASIC element of informed consent according to the US FDA regulations?
- AA statement that the procedure may involve risks to the subject which are currently unforseeable
- BAny additional costs to the subject that may result from participation in the research
- CThe approximate number of subjects involved in the study
- DContact information for questions about the research, subjects rights and research related injuries
18When may an investigator break the blind without pre-approval by the sponsor?
- Aafter the study is completed
- Bif the subject requests to know
- Cif an SAE occurs
- Dwhen study subject safety is jeopardized
19An investigator has become a member of the local IRB/IEC for a 2-year term and also conducts a study approved by this same IRB/IEC for which enrollment began 6 months ago and will continue for another 24 months. The CRC is submitting a protocol amendment, which, according to the IRB/IEC needs to be reviewed and approve d at the next committee meeting due to the many changes involved. for this amendment, the CRC shoudl be aware that the
- Ainvestigator must abstain from the deliberations and voting process
- BIRB/IEC chair must allow the CRC to deliberate and vote in the place of the investigator
- Cinvestigator must abstain form the investigator duties during the deliberation and voting process
- DIRB/IEC chair must allow the investigator to deliberate and vote
20A site is conducting a study in which Drug A is being compared to Drug B. The study medication is administered in the hospital and continued after discharge. Peak and trough blood levels are ordered to be drawn each AM while hospitalized. Upon review of the hospital records, the CRC discovers that five of the ten subjects enrolled did not have the ordered blood levels drawn on the day of discharge. The CRC should
- Ainform the IRB/IEC immediately, document in the source, and note "not done" on the CRF
- Binform the IRB/IEC immediately, document in the source, and review the discharge procedures with the staff
- Cdocument in the source, note "not done" on the CRF, and review the discharge procedures with the staff
- Dinform the IRB/IEC immediately, note "not done" on the CRF, and review the discharge procedures with the staff
21A site is conducting a study in which Drug A is being compared to Drug B. The study medication is administered in the hospital and continued after discharge. Peak and trough blood levels are ordered to be drawn each AM while hospitalized. Upon review of the hospital records, the CRC discovers that five of the ten subjects enrolled did not have the ordered blood levels drawn on the day of discharge. The CRC should
- Ainform the IRB/IEC immediately, document in the source, and note "not done" on the CRF
- Binform the IRB/IEC immediately, document in the source, and review the discharge procedures with the staff
- Cdocument in the source, note "not done" on the CRF, and review the discharge procedures with the staff
- Dinform the IRB/IEC immediately, note "not done" on the CRF, and review the discharge procedures with the staff
22According to ICH, which of the following are considered SAEs?
- Apregnancy resulting in normal delivery of twins and use of illicit drug during the study
- Binfection following surgery prolonging hospital stay and pregnancy resulting in normal delivery of twins
- CMVA was admitted in hospital for observation and use of illicit drug during the study
- Dinfection following surgery prolonging hospital stay and MVA was admitted in hospital for observation
23A subject arrives for a study visit on the last day of the protocol visit window. Because of bad weather, the drug re-supply shipment did not arrive. The patient must not miss any dose of the open-label study drug. The CRC
- Acall study sponsor for permission to re-dispense subjects leftover tablets and proceed with visit
- Bre-schedule the study visit
- Cdiscontinue the patient and perform early termination procedures
- Dmust have investigator write a prescription for the open-label drug
24During a phase III study, a subject develops a systemic rash one day after administration of the study drug, which is the first event of its kind. Based only on the information given, the adverse event is most likely reportable as
- Aan adverse drug reaction
- Ba serious adverse event
- Can unexpected adverse event
- Da severe adverse event
25A sponsor has offered a physician a new protocol. The CRC knows that this physician is already over-committed. The sponsor representative has been calling the CRC for updates on regulatory documents. What is the best course of action for the CRC to take?
- ATell them you are over committed and that they will need to get these documents from the potential PI
- BDo not respond to their phone message
- Ctell them that you are waiting to hear from the IRB
- DTell them to submit their inquiries directly to the investigator
26A subject present to the office with a recent onset of decreased hemoglobin at Visit 4. Decreased hemoglobin is listed in the risk information contained in the Investigators Brochure. Which of the following should the CRC do?
- AAdd "decreased hemoglobin to the comments section in the CRF?
- BDocument decreased hemoglobin as an AE
- CReport decreased hemoglobin as an unexpected AE
- DComplete SAE form and submit to sponsor within 24 hours of occurence
27In qualifying a subject for entry into the study, the CRC notices slightly elevated liver enzymes on the screening lab report. The protocol states that subjects with clinically significant deviations from reference range values should be excluded from the study. What would be the appropriate course of action?
- ANotify the subject that he/she is not eligible for the study
- BRetest liver enzymes immediately to confirm initial lab results
- Callow the subject to continue and monitor liver enzymes daily
- DInform the subject about the lab results and request a waiver from the sponsor's medical monitor
28A screening procedure that qualifies as minimal risk in a study that is considered to present greater that minimal risk requires
- Afull consent
- BIRB/IEC acknowledgment
- Cscreening consent
- Dno consent
29The type of clinical trial designed to prevent investigators form assigning those patients whom they think have the best prognosis to what they believe is the superior therapy is
- Ablinded control
- Boutcome studies
- Crandomized
- Dstratified
30Recruitment in an osteoporosis study is a site-specific problem. Which of the following is the least likely factor contributiong to recruitment problems?
- ABudget insufficient to meet screening needs
- BThe clinic is not open on Saturdays
- CSubjects being screened are too young for the disease under investigation
- DThe CRC is involved in too many studies to focus on the recruitment phase of this study
31In order to ensure that an investigative site can provide adequate storage space for the test article and study supplies, the sponsor would conduct?
- AA telephone conference with the site
- BA pre-study site evalutaion
- CAn investigators meeting
- Dan initiation visit
32During the initial review of the protocol the CRC has questions about the study procedures. The CRC should do which of the following?
- ADiscuss the question with another CRC
- BPresent questions and concerns at the investigators meeting
- CDecline to participate in the study
- DNotify the IRB/IEC of questions and concerns
33An informed consent form is changed to reflect an additional interim visit at Month 6. Current subjects have completed the month 8 visit. Which of the following subjects should sing the new consent form?
- ASubjects who enter the study after the change
- BAll subjects active in the study
- CSubjects who are still active in the study and are past month 6
- DAll active and completed subjects
34A CRC is planning the final report to the sponsor for an osteoporosis study. She learns that a sub-investigator did not perform the exit physical examinations for six subjects as required by the protocol. What should the CRC do FIRST?
- Ainform the PI of the protocol deviation
- BAsk the sub-investigator to mark the physical exam (PE) CRF as "not done"
- CSchedule the subjects for an exit physical exam
- DComplete the report and a note to file about the missing data deviation
35During the course of a clinical study, for which of the following items woldl a sponsor most likely reimburse a site?
- Aan increase in subject stipend
- Bprescriptions ordered during study participation
- Ca hospitalization occurring during a study
- Dadditional visits or tests due to an AE
36During the course of a clinical study, for which of the following items woldl a sponsor most likely reimburse a site?
- Aan increase in subject stipend
- Bprescriptions ordered during study participation
- Ca hospitalization occurring during a study
- Dadditional visits or tests due to an AE
37Which of the following items should be included in the formal close-out report from the site to the IRB/IEC?
- Adate the IRB/IEC approved the study, date the last subject was enrolled and total number of adverse events that occurred?
- Btotal number of subjects enrolled, date the last subject was enrolled and total number of adverse events that occurred
- Ctotal number of subjects enrolled, date the IRB/IEC approved the study, and date the last subject was enrolled
- Ddate the last subject was enrolled, and date the IRB/IEC approved the study,
38Which of the following items should be included in the formal close-out report from the site to the IRB/IEC?
- Adate the IRB/IEC approved the study, date the last subject was enrolled and total number of adverse events that occurred?
- Btotal number of subjects enrolled, date the last subject was enrolled and total number of adverse events that occurred
- Ctotal number of subjects enrolled, date the IRB/IEC approved the study, and date the last subject was enrolled
- Ddate the last subject was enrolled, and date the IRB/IEC approved the study,
39The difference between a short-form informed consent and the regular informed consent is that a short-form
- Ais a written summary provided to the subject
- Brequires two witnesses
- Cis presented orally
- Dmust be signed by the person obtaining consent
40For a protocol investigating a new test article, the CRC has been obtaining informed consent keeping the original consent form for the investigator and preparing a copy of the consent form for the subject. What other actions should the investigator ensure are being carried out?
- Ahaving the CRC date all the signatures on the informed consent documents
- Bdocumenting in the case history that informed consent was obrained prior to the conduct of any research related procdure
- Cplacing copies of the informed consent documents in the subjects medical records
- Dproviding a copy of each signed informed consent to the IRB/IEC.
41The investigator requests that the study coordinator maintain the dispensing log/record in the immediate research office, even though a pharmacy is responsible for storing and dispensing study drug. The CRC may best respond to this request by
- Asuggesting that the investigator read the regulations-related to storage and dispensing of investigational drugs
- Bmaintaining the dispensing log in her office according to regulations
- Cexplaining to the investigator that the log should be maintained in the pharmacy where the drug is dispensed.
- Drequesting that the monitor/CRA explain the regulations regarding the responsibilities and obligations of the sponsor
42A phase I study proposal had a sample size of 30. Two subjects were disqualified due to protocol violations and the total number enrolled was 32. The IRB/IEC Director may query the investigator for which of the following reasons
- ANo SAE reports were submitted
- BThe study closed sooner than anticipated
- CAn amendment should have been obtained and approved to increase the sample size to 32
- DThe protocol should have been submitted under expedited review procedures
43An investigator encounters a subject in a life-threatening situation (unconscious, no time to obtain informed consent from anyone). No standard acceptable treatment is available. An investigational drug is the only means available to save the subject's life. The investigator decides to administer the drug according the FDA's emergency use provision. The IRB must be notified about this emergency use by means of a written report from the investigator and
- Aa member of the FDA's Drug Information Branch
- Bthe sponsor
- Can independent physician
- Da sub-investigator listed on the 1572
44in which of the following circumstances would it be acceptable to administer a test article to a pregnant subject?
- AShe states that she will terminate the pregnacny
- BShe has no insurance
- CShe is a single parent
- DShe has a life-threatening injury
45As a CRC coordinating a cardiac medical device study, which of the following would generally be considered the most qualified person to monitor your site?
- Athe IRB/IEC chairperson
- Bthe engineer who developed the device
- Ca cardiologist not associated with the PI
- Da nurse with an understanding of the study and monitoring experience
46According to the CFR, an unexpected adverse drug experience (ADE) is
- Aany reaction that is listed in the Investigators Brochure, but is not listed in the Product Labeling due to infrequency of occurrences
- Ba fatal or life threatening clinical experience, birth malformation, permanently disabling event,or hospitalizing evemt
- Cone not identified in nature, severity, or frequency in the current labeling, Investigators Brochure, general investigational plan, or IND
- Done that occurrs occasionally in a subgroup of subjects, but is not believed to be associated with the study medication
- Aany reaction that is listed in the Investigators Brochure, but is not listed in the Product Labeling due to infrequency of occurrences
47According to the CFR, an unexpected adverse drug experience (ADE) is
- Aany reaction that is listed in the Investigators Brochure, but is not listed in the Product Labeling due to infrequency of occurrences
- Ba fatal or life threatening clinical experience, birth malformation, permanently disabling event,or hospitalizing evemt
- Cone not identified in nature, severity, or frequency in the current labeling, Investigators Brochure, general investigational plan, or IND
- Done that occurrs occasionally in a subgroup of subjects, but is not believed to be associated with the study medication
- Aany reaction that is listed in the Investigators Brochure, but is not listed in the Product Labeling due to infrequency of occurrences
48a 15-year-old girl would like to screen for a study. She is on spring break and her parents have given verbal permission. Her grandmother brings her in for the screening visit with a letter from her parents approving medical care. Can she be screened for the study ?
- Ayes, the grandmother may sign as the legal guardian
- Bno, a legal guardian must be present to sign the informed consent
- Cyes, anyone over 18 who brings a child in as under their custody may sign an informed consent for a minor
- Dyes, the grandmother may sign the informed consent and attach the parents permission letter to the informed consent
49When does a study site become responsible for submitting IND safety reports to the IRB/IEC
- Aafter the test article is received on site
- Bas soon as reports are received from the sponsor
- Cafter subject screening procedures begin
- Dafter the first subject enrolls
50A subject has been enrolled under an emergency use of an investigational product. Within how many working day should the IRB/IEC be notified?
- A7
- B1
- C5
- D3
51A well-defined clinical study using a placebo to evaluate the reference group is called a/an ____________ clinical trial
- Acontrolled
- Bactive concurrent controlled
- Cparallel
- Dcrossover
52The main purpose of a a study specific source document checklist is to
- Aensure all study procedures have occurred
- Bdocument how data is controlled
- Cdocument that the study was properly conducted
- Dtrain the CRC on how to conduct the study
53An investigator conducts and completes the informed consent process with a subject, who them completes all of the day 1 requirements and is ready to leave, however, the CRC notices that the investigator did not sign the informed consent document and will not be able to obtain the investigators signature for many hours. The protocol indicates that the ICH Good Clinical Practices Guideline will be followed throughout the study . Which of the following should the CRC do?
- ASign for the investigator and provide the subject with a copy
- BKeep the subject around until the investigator is available
- Cgive the subject an unsigned copy of the consent form
- DMail the completely signed consent to the subject.
54A Phase I clinical trial is underway at a site for adult-onset diabetes. The common side effects of the study medication include fatigue, dizziness, low blood sugar, nausea, and heartburn. A subject calls to report the following signs and symptoms: confusion, sweating and hand tremor. Given this information, the CRC should anticipate the PI classifying these events as
- Amoderate, possible related and not severe
- Bmoderate, unrelated and serious
- Csevere, probably related and serious
- Dmild, unrelated and not serious
55Which of the following might be considered sources in order for determining local laboratory costs?
- Aprevious budget with this sponsor and PI
- Bprevious budget with this sponsor and lab fee schedule
- Claboratory director and PI
- Dlaboratory director and laboratory fee schedule
56A subject is in a study for the treatment of coronary artery disease. In addition to study medication, the subject is taking aspirin daily. The subject dies from gastrointestinal bleeding related o excessive aspirin ingestion. This is classifed as
- Aan unexpected AE
- Ba primary endpoint
- Ca serious adverse event
- Dan unexpected outcome
57During her first week on study medication, a subject called the site to report that she had generalized, pruritic (itchy) rash, which has caused extreme discomfort. What is the best course of action for the CRC to take?
- AStop study medication immediately
- BTell her to come into the office for an interim visit
- CTell her to take benadryl immediately
- Dtell her to keep track of the rash so she can give you an accurate history at the next study visit
58According to the FDA regulations, which of the following is the best example of a vulnerable subject?
- Aa nun
- Ban HMO participant
- Ca pregnant woman
- Da long-time patient of the investigator
59A change in weight of greater than or equal to 10 %between visits 1 and 3 is an exclusion criterion. The subject weiged 130 lbs at visit 1. The subjet would be excluded at what minimum weight prior to or at visit 3?
- A150
- B145
- C143
- D135
60in determining the feasibility of a hypertension study, A CRC realizes that the protocol requires an automatic blood pressure machine with a measurement printout be used foe all study-related blood pressures. As the site is not equipped with such a device , the first action of the CRC should be to
- Aperform the study without the equipment
- Bturn the study down due to lack of equipment
- Cask the sponsor to supply the equipment
- Drent the equipment from an outside vendor
61A CRA has sent the site a pre-study informational packet in preparation for an upcoming site visit. for the staff to know as much about the history of the drug as possible, they should read the
- Ainformed consent
- Binvestigational plan
- Cstudy protocol
- Dinvestigator's brochure
62a subject in an oral birth control study calls the office and informs the CRC that her home pregnancy test is positive. What should the CRC do first?
- Ahave subject repeat the test at home and notify the clinic of the results
- BInstruct the subject to withhold the test article and come in for a serum pregnancy test immediately
- Crequest that the subject come in early for her next visit to check compliance
- Dinform the PI and report the event to the sponsor as an SAE
63If a subject in a long-term, open-label maintenance study requires knee replacement surgery, which of the following is true?
- AIt is not necessary to file a serious adverse event report
- Bthe subject may continue with no interruption in study medication assuming the patient is in Phase IIIB
- CThe admitting hospital's IRB/IEC must give approval for the subject to continue the study medication
- DThe sponsor should determine if the subject may remain in the study
64A subject is participating in a clinical trial where only the CRC knows the identity of the study medication. This is considered to be which of the following types of studies?
- Asingle-blinded
- Bopen-label
- Ccrossover
- Dplacebo-controlled
65Who is ultimately responsible for the proper storage and accountability of the test article?
- ACRA
- BPI
- CCRC
- Dpharmacist
66FDA has decided to disqualify a clinical investigator for submitting false information to the sponsor in a required clinical report. The first action likely to be taken is to
- Aprovide the investigator verbal notification
- Boffer the investigator an opportunity to explain the matter in an informal hearing
- Cprovide the investigator with written notification
- Doffer the investigator an opportunity to explain the matter in writing
67An AE that was not evident during baseline is considered to be
- Aunexpected
- Ba pre-existing condition
- Can un-toward medical event
- Dan SAE
68According to CFR, which of the following must the investigator report to the IRB/IEC?
- Aany subjects considered lost to follow-up
- Bdisclosure of any financial interests
- Cthe addition of a sub-investigator to the study
- Da protocol change reducing the number of blood draws from 8 to 6
69If a subject is hospitalized for more than 24 hours during the course of a study due to a fractured arm, it would be considered
- Adrug-related
- Ban adverse event
- Ca serious adverse event
- Dan accident
70a CRA has made several interim monitoring visits to a site and kept notes on the following for each subject in the study: date of consent signature, date of first dose of test article; visit dates (scheduled and actual); compliance with test article; and adverse events. The CRA is being assigned to a different project. Which of the following should the CRC recommend as the best way for the outgoing CRA to provide the incoming CRA with the necessary information specific to your site?
- Aprovide the ledger pad(s) on which the original CRA's notes were recorded
- Bsupply the information from the most recent site visit
- Cprovide an opportunity to discuss the specifics regarding each subject
- Dprovide separate worksheets documenting the information for each subject
71 A subject dies 2 days before a long-term follow-up visit and had been off the study drug for 2 weeks. This would be reported as
- Aan adverse event
- Bearly termination
- Ca serious adverse event
- Da side effect
72A CRC is reviewing a protocol for a Phase 1 study. The objective for conducting the study could be used to determine the
- Ablood levels of acetaminophen in post-partum patients when taken on an empty stomach versus 2 hours after meal consumption
- Btherapeutic dosage of test article in reducing soft tissue inflammation following third molar extractions
- Csafety and efficacy of chemotherapy agent "x"versus placebo in alleviating pain in osteoarthritis patients
- Dtherapeutic dosages at which caffeine enhances acetylsalicylic acid absorption in normal, healthy volunteers
73The sponsor provides a sample informed consent form to potential study sites in order to
- Afulfill the FDA obligation
- Bdocument the appropriate consent content
- Csatisfy the investigators demands
- Dinform the IRB/IEC of the correct version
74The CRC is preparing the budget for the protocol. The cost of the study is $12,000. the indirect cost for the institute is 25%. The total cost for the protocol is
- A$15,000
- B$13,500
- C$12,000
- D$15,500
75When reviewing a protocol, the schedule of study events would most likely be presented
- Ain the protocol text and as a table appended to the protocol
- Bin the protocol text and by referring to the events section of the study manual
- Cby referring to the events section of the study manual and using a patient schedule of visits
- Das a table appended to the protocol and using a patient schedule of visits
76Which of the following are considered tasks that the CRC would complete prior to the next routine monitoring visit ?
- Areviewthe CRF to ensure all data has been transcribed and send the original CRF pages to the CRA for review
- BReview the CRF to ensure all data to date has been transcribed and record investigational product dispensation completed to date
- CEnter all projected visit dates on the enrollment log and send the original CRF pages to the CRA for review
- DEnter all projected visit dates on the enrollment log and record investigational product dispensation completed to date
77Which of the following Tasks should A CRC complete prior to the enrollment of subjects?
- Acoordinate the process for completion of study-related procedures and tests
- Bdiscontinue all excluded medications for potential subjects
- Cconduct initial protocol training with site Staff
- Dinform primary care physician of subjects interest in the study
78A subject in a hormone replacement study has an AE described as breakthrough bleeding ongoing at the completion of the study . The subject refuses an endometrial biopsy, and is referred to her primary care physician for follow-up. Two months later, the subjects primary care physician calls and wants to know what the subject was taking while in the study. The sponsor suggests that the blind not be broken. Which of the following should the CRC do?
- AGet the subjects's permission and then break the blind
- BDo not break the blind and have the PI call the primary care physician
- CGet the PI's permission and then break the blind
- DDo not break the blind, but immediately notify the IRB/IEC of the request
79During the medical history/physical exam portion of an assessment for a study, The CRC notices a 5-inch scar on the right leg of the subject. The CRC asks the subject about the scar and the subject states that it was melanoma. The CRC should record this in the medical history section of the CRF under
- Arenal
- Bhepatic
- Cimmunologic
- Ddermatological
80A protocol requires that subjects in a hypertension trial have two consecutive sitting diastolic blood pressure readings performed and the average of the two recorded on the CRF. The CRA discovers that only one blood pressure reading is recorded in the source documents, which is the same as the reading recorded in the CRF for the 10 enrolled subjects. Which of the following would the CRC expect the CRA to do first?
- Aask the investigator if the blood pressure procedure outlined in the protocol is being followed
- BNotify data management department that the CRF entries are incorrect and may need to be queried
- CContact the medical monitor to discuss closing the site due to 10 protocol violations
- Dcontact the medical monitor to report the investigator is non-compliant with the protocol
Información
- Descripción
- CRC certification Test sobre CRC Exam Pre-test 2005, creado por cmulvey el 30/07/2014.
- Autor
- cmulvey
- Idioma
- English
- Visitas
- 530
- Etiquetas
- Valoración
- 4,3 de 5 · 3 valoraciones Valora este test