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CRC Exam Pre-test 2005

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CRC certification Quiz on CRC Exam Pre-test 2005, created by cmulvey on 30/07/2014.
cmulvey
Quiz by cmulvey, updated more than 1 year ago
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Created by cmulvey almost 10 years ago
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Resource summary

Question 1

Question
Who is responsible for writing and filing the IND safety report to the regulatory authority?
Answer
  • investigator
  • sponsor
  • IRb/IEC
  • study coordinaor

Question 2

Question
The 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?
Answer
  • confirmation of date of next study visit, compliance in taking the test article and visits to the primary physicians
  • reports of major medical events and visits to primary care physicians
  • confirmation of date of next study visit, reports of major medical events and changes in concomitant medications
  • compliance in taking the test article and changes in concomitant medications

Question 3

Question
the investigator must notify the IRB/IEC of an significant new findings during the course of the study when the _________
Answer
  • investigator has notified all subjects
  • final report is submitted to the sponsor
  • information becomes available to the investigator
  • sponsor submits the final report to the FDA

Question 4

Question
When a subject reports an adverse event, who is responsible for determining its "relationship to the study drug"?
Answer
  • CRA
  • IRB/IEC
  • Investigator
  • CRC

Question 5

Question
A CRA is responsible for which of the following?
Answer
  • reviewing charts for potential subjects
  • notifying the FDA of any AE's
  • assessing the performance of the investigator
  • preparing the application for IRB/IEC submission

Question 6

Question
A 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?
Answer
  • the investigator and a physician associated with the IRB/IEC
  • the investigator and a sponsor representative
  • the subject cannot enroll as such waivers are not allowed
  • the investigator and an independent physician

Question 7

Question
At 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?
Answer
  • Classify the subject as dropped from the date at which the noncompliance began
  • Report the subject's noncompliance to MedWatch using Form 3500A
  • Recalculate compliance for each visit to determine a more accurate compliance percentage based on the subject's verbal account
  • Document the available information surrounding the noncompliance in the CRF

Question 8

Question
When advertising for research subjects in a local newspaper, which of the following are most appropriate to be included?
Answer
  • possible benefits of participation, including improvement in disease
  • required age, gender, and diagnosis of eligible subjects
  • name of the sponsor
  • name of the study drug

Question 9

Question
under certain circumstances it may be necessary to disclose Protected Health Information (PHI) without prior written permission of the subject. Those circumstances would be
Answer
  • insurance company requests
  • family member inquiries
  • non existant
  • medical emergencies

Question 10

Question
After signing a consent form for a double-blind placebo-controleld study, the subject says, "i know this medicine willcure me". this statement may indicate
Answer
  • the subject wants access to the drug withotg participating as a subject in the study
  • the subject may have signed the informed consent form under duress
  • the subject does not fully understand the study
  • the subject is of the impression that this study involves a marketed drug

Question 11

Question
A 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?
Answer
  • Notify the sponsor within 24 hours
  • Notify the IRB/IEC immediately
  • Document as an AE
  • Document as an SAE

Question 12

Question
According to ICH guidelines, an adult who is illiterate may be considered as a subject for a clinical study under which of the following circumstances?
Answer
  • with an impartial witness signature on the informed consent
  • provided the subjects legal representative witnesses the informed consent
  • under no circumstances
  • if the subject can understand the oral consent and sign with an x

Question 13

Question
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?
Answer
  • 68 kg and 165 cm
  • 60 kg and 143 cm
  • 72 kg and 170 cm
  • 75 kg and 180 cm

Question 14

Question
A 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?
Answer
  • financial disclosure updates
  • screening logs
  • FDA Form 1572
  • IRB/IEC approval

Question 15

Question
A 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?
Answer
  • financial disclosure updates
  • screening logs
  • FDA Form 1572
  • IRB/IEC approval

Question 16

Question
A subjects study-specific flow sheet should be stored with
Answer
  • medical records
  • regulatory docs
  • drug accountablity
  • source documents

Question 17

Question
Which of the following is a BASIC element of informed consent according to the US FDA regulations?
Answer
  • A statement that the procedure may involve risks to the subject which are currently unforseeable
  • Any additional costs to the subject that may result from participation in the research
  • The approximate number of subjects involved in the study
  • Contact information for questions about the research, subjects rights and research related injuries

Question 18

Question
When may an investigator break the blind without pre-approval by the sponsor?
Answer
  • after the study is completed
  • if the subject requests to know
  • if an SAE occurs
  • when study subject safety is jeopardized

Question 19

Question
An 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
Answer
  • investigator must abstain from the deliberations and voting process
  • IRB/IEC chair must allow the CRC to deliberate and vote in the place of the investigator
  • investigator must abstain form the investigator duties during the deliberation and voting process
  • IRB/IEC chair must allow the investigator to deliberate and vote

Question 20

Question
A 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
Answer
  • inform the IRB/IEC immediately, document in the source, and note "not done" on the CRF
  • inform the IRB/IEC immediately, document in the source, and review the discharge procedures with the staff
  • document in the source, note "not done" on the CRF, and review the discharge procedures with the staff
  • inform the IRB/IEC immediately, note "not done" on the CRF, and review the discharge procedures with the staff

Question 21

Question
A 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
Answer
  • inform the IRB/IEC immediately, document in the source, and note "not done" on the CRF
  • inform the IRB/IEC immediately, document in the source, and review the discharge procedures with the staff
  • document in the source, note "not done" on the CRF, and review the discharge procedures with the staff
  • inform the IRB/IEC immediately, note "not done" on the CRF, and review the discharge procedures with the staff

Question 22

Question
According to ICH, which of the following are considered SAEs?
Answer
  • pregnancy resulting in normal delivery of twins and use of illicit drug during the study
  • infection following surgery prolonging hospital stay and pregnancy resulting in normal delivery of twins
  • MVA was admitted in hospital for observation and use of illicit drug during the study
  • infection following surgery prolonging hospital stay and MVA was admitted in hospital for observation

Question 23

Question
A 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
Answer
  • call study sponsor for permission to re-dispense subjects leftover tablets and proceed with visit
  • re-schedule the study visit
  • discontinue the patient and perform early termination procedures
  • must have investigator write a prescription for the open-label drug

Question 24

Question
During 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
Answer
  • an adverse drug reaction
  • a serious adverse event
  • an unexpected adverse event
  • a severe adverse event

Question 25

Question
A 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?
Answer
  • Tell them you are over committed and that they will need to get these documents from the potential PI
  • Do not respond to their phone message
  • tell them that you are waiting to hear from the IRB
  • Tell them to submit their inquiries directly to the investigator

Question 26

Question
A 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?
Answer
  • Add "decreased hemoglobin to the comments section in the CRF?
  • Document decreased hemoglobin as an AE
  • Report decreased hemoglobin as an unexpected AE
  • Complete SAE form and submit to sponsor within 24 hours of occurence

Question 27

Question
In 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?
Answer
  • Notify the subject that he/she is not eligible for the study
  • Retest liver enzymes immediately to confirm initial lab results
  • allow the subject to continue and monitor liver enzymes daily
  • Inform the subject about the lab results and request a waiver from the sponsor's medical monitor

Question 28

Question
A screening procedure that qualifies as minimal risk in a study that is considered to present greater that minimal risk requires
Answer
  • full consent
  • IRB/IEC acknowledgment
  • screening consent
  • no consent

Question 29

Question
The 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
Answer
  • blinded control
  • outcome studies
  • randomized
  • stratified

Question 30

Question
Recruitment in an osteoporosis study is a site-specific problem. Which of the following is the least likely factor contributiong to recruitment problems?
Answer
  • Budget insufficient to meet screening needs
  • The clinic is not open on Saturdays
  • Subjects being screened are too young for the disease under investigation
  • The CRC is involved in too many studies to focus on the recruitment phase of this study

Question 31

Question
In order to ensure that an investigative site can provide adequate storage space for the test article and study supplies, the sponsor would conduct?
Answer
  • A telephone conference with the site
  • A pre-study site evalutaion
  • An investigators meeting
  • an initiation visit

Question 32

Question
During the initial review of the protocol the CRC has questions about the study procedures. The CRC should do which of the following?
Answer
  • Discuss the question with another CRC
  • Present questions and concerns at the investigators meeting
  • Decline to participate in the study
  • Notify the IRB/IEC of questions and concerns

Question 33

Question
An 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?
Answer
  • Subjects who enter the study after the change
  • All subjects active in the study
  • Subjects who are still active in the study and are past month 6
  • All active and completed subjects

Question 34

Question
A 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?
Answer
  • inform the PI of the protocol deviation
  • Ask the sub-investigator to mark the physical exam (PE) CRF as "not done"
  • Schedule the subjects for an exit physical exam
  • Complete the report and a note to file about the missing data deviation

Question 35

Question
During the course of a clinical study, for which of the following items woldl a sponsor most likely reimburse a site?
Answer
  • an increase in subject stipend
  • prescriptions ordered during study participation
  • a hospitalization occurring during a study
  • additional visits or tests due to an AE

Question 36

Question
During the course of a clinical study, for which of the following items woldl a sponsor most likely reimburse a site?
Answer
  • an increase in subject stipend
  • prescriptions ordered during study participation
  • a hospitalization occurring during a study
  • additional visits or tests due to an AE

Question 37

Question
Which of the following items should be included in the formal close-out report from the site to the IRB/IEC?
Answer
  • date the IRB/IEC approved the study, date the last subject was enrolled and total number of adverse events that occurred?
  • total number of subjects enrolled, date the last subject was enrolled and total number of adverse events that occurred
  • total number of subjects enrolled, date the IRB/IEC approved the study, and date the last subject was enrolled
  • date the last subject was enrolled, and date the IRB/IEC approved the study,

Question 38

Question
Which of the following items should be included in the formal close-out report from the site to the IRB/IEC?
Answer
  • date the IRB/IEC approved the study, date the last subject was enrolled and total number of adverse events that occurred?
  • total number of subjects enrolled, date the last subject was enrolled and total number of adverse events that occurred
  • total number of subjects enrolled, date the IRB/IEC approved the study, and date the last subject was enrolled
  • date the last subject was enrolled, and date the IRB/IEC approved the study,

Question 39

Question
The difference between a short-form informed consent and the regular informed consent is that a short-form
Answer
  • is a written summary provided to the subject
  • requires two witnesses
  • is presented orally
  • must be signed by the person obtaining consent

Question 40

Question
For 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?
Answer
  • having the CRC date all the signatures on the informed consent documents
  • documenting in the case history that informed consent was obrained prior to the conduct of any research related procdure
  • placing copies of the informed consent documents in the subjects medical records
  • providing a copy of each signed informed consent to the IRB/IEC.

Question 41

Question
The 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
Answer
  • suggesting that the investigator read the regulations-related to storage and dispensing of investigational drugs
  • maintaining the dispensing log in her office according to regulations
  • explaining to the investigator that the log should be maintained in the pharmacy where the drug is dispensed.
  • requesting that the monitor/CRA explain the regulations regarding the responsibilities and obligations of the sponsor

Question 42

Question
A 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
Answer
  • No SAE reports were submitted
  • The study closed sooner than anticipated
  • An amendment should have been obtained and approved to increase the sample size to 32
  • The protocol should have been submitted under expedited review procedures

Question 43

Question
An 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
Answer
  • a member of the FDA's Drug Information Branch
  • the sponsor
  • an independent physician
  • a sub-investigator listed on the 1572

Question 44

Question
in which of the following circumstances would it be acceptable to administer a test article to a pregnant subject?
Answer
  • She states that she will terminate the pregnacny
  • She has no insurance
  • She is a single parent
  • She has a life-threatening injury

Question 45

Question
As a CRC coordinating a cardiac medical device study, which of the following would generally be considered the most qualified person to monitor your site?
Answer
  • the IRB/IEC chairperson
  • the engineer who developed the device
  • a cardiologist not associated with the PI
  • a nurse with an understanding of the study and monitoring experience

Question 46

Question
According to the CFR, an unexpected adverse drug experience (ADE) is
Answer
  • any reaction that is listed in the Investigators Brochure, but is not listed in the Product Labeling due to infrequency of occurrences
  • a fatal or life threatening clinical experience, birth malformation, permanently disabling event,or hospitalizing evemt
  • one not identified in nature, severity, or frequency in the current labeling, Investigators Brochure, general investigational plan, or IND
  • one that occurrs occasionally in a subgroup of subjects, but is not believed to be associated with the study medication

Question 47

Question
According to the CFR, an unexpected adverse drug experience (ADE) is
Answer
  • any reaction that is listed in the Investigators Brochure, but is not listed in the Product Labeling due to infrequency of occurrences
  • a fatal or life threatening clinical experience, birth malformation, permanently disabling event,or hospitalizing evemt
  • one not identified in nature, severity, or frequency in the current labeling, Investigators Brochure, general investigational plan, or IND
  • one that occurrs occasionally in a subgroup of subjects, but is not believed to be associated with the study medication

Question 48

Question
a 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 ?
Answer
  • yes, the grandmother may sign as the legal guardian
  • no, a legal guardian must be present to sign the informed consent
  • yes, anyone over 18 who brings a child in as under their custody may sign an informed consent for a minor
  • yes, the grandmother may sign the informed consent and attach the parents permission letter to the informed consent

Question 49

Question
When does a study site become responsible for submitting IND safety reports to the IRB/IEC
Answer
  • after the test article is received on site
  • as soon as reports are received from the sponsor
  • after subject screening procedures begin
  • after the first subject enrolls

Question 50

Question
A subject has been enrolled under an emergency use of an investigational product. Within how many working day should the IRB/IEC be notified?
Answer
  • 7
  • 1
  • 5
  • 3

Question 51

Question
A well-defined clinical study using a placebo to evaluate the reference group is called a/an ____________ clinical trial
Answer
  • controlled
  • active concurrent controlled
  • parallel
  • crossover

Question 52

Question
The main purpose of a a study specific source document checklist is to
Answer
  • ensure all study procedures have occurred
  • document how data is controlled
  • document that the study was properly conducted
  • train the CRC on how to conduct the study

Question 53

Question
An 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?
Answer
  • Sign for the investigator and provide the subject with a copy
  • Keep the subject around until the investigator is available
  • give the subject an unsigned copy of the consent form
  • Mail the completely signed consent to the subject.

Question 54

Question
A 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
Answer
  • moderate, possible related and not severe
  • moderate, unrelated and serious
  • severe, probably related and serious
  • mild, unrelated and not serious

Question 55

Question
Which of the following might be considered sources in order for determining local laboratory costs?
Answer
  • previous budget with this sponsor and PI
  • previous budget with this sponsor and lab fee schedule
  • laboratory director and PI
  • laboratory director and laboratory fee schedule

Question 56

Question
A 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
Answer
  • an unexpected AE
  • a primary endpoint
  • a serious adverse event
  • an unexpected outcome

Question 57

Question
During 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?
Answer
  • Stop study medication immediately
  • Tell her to come into the office for an interim visit
  • Tell her to take benadryl immediately
  • tell her to keep track of the rash so she can give you an accurate history at the next study visit

Question 58

Question
According to the FDA regulations, which of the following is the best example of a vulnerable subject?
Answer
  • a nun
  • an HMO participant
  • a pregnant woman
  • a long-time patient of the investigator

Question 59

Question
A 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?
Answer
  • 150
  • 145
  • 143
  • 135

Question 60

Question
in 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
Answer
  • perform the study without the equipment
  • turn the study down due to lack of equipment
  • ask the sponsor to supply the equipment
  • rent the equipment from an outside vendor

Question 61

Question
A 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
Answer
  • informed consent
  • investigational plan
  • study protocol
  • investigator's brochure

Question 62

Question
a 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?
Answer
  • have subject repeat the test at home and notify the clinic of the results
  • Instruct the subject to withhold the test article and come in for a serum pregnancy test immediately
  • request that the subject come in early for her next visit to check compliance
  • inform the PI and report the event to the sponsor as an SAE

Question 63

Question
If a subject in a long-term, open-label maintenance study requires knee replacement surgery, which of the following is true?
Answer
  • It is not necessary to file a serious adverse event report
  • the subject may continue with no interruption in study medication assuming the patient is in Phase IIIB
  • The admitting hospital's IRB/IEC must give approval for the subject to continue the study medication
  • The sponsor should determine if the subject may remain in the study

Question 64

Question
A 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?
Answer
  • single-blinded
  • open-label
  • crossover
  • placebo-controlled

Question 65

Question
Who is ultimately responsible for the proper storage and accountability of the test article?
Answer
  • CRA
  • PI
  • CRC
  • pharmacist

Question 66

Question
FDA 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
Answer
  • provide the investigator verbal notification
  • offer the investigator an opportunity to explain the matter in an informal hearing
  • provide the investigator with written notification
  • offer the investigator an opportunity to explain the matter in writing

Question 67

Question
An AE that was not evident during baseline is considered to be
Answer
  • unexpected
  • a pre-existing condition
  • an un-toward medical event
  • an SAE

Question 68

Question
According to CFR, which of the following must the investigator report to the IRB/IEC?
Answer
  • any subjects considered lost to follow-up
  • disclosure of any financial interests
  • the addition of a sub-investigator to the study
  • a protocol change reducing the number of blood draws from 8 to 6

Question 69

Question
If a subject is hospitalized for more than 24 hours during the course of a study due to a fractured arm, it would be considered
Answer
  • drug-related
  • an adverse event
  • a serious adverse event
  • an accident

Question 70

Question
a 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?
Answer
  • provide the ledger pad(s) on which the original CRA's notes were recorded
  • supply the information from the most recent site visit
  • provide an opportunity to discuss the specifics regarding each subject
  • provide separate worksheets documenting the information for each subject

Question 71

Question
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
Answer
  • an adverse event
  • early termination
  • a serious adverse event
  • a side effect

Question 72

Question
A CRC is reviewing a protocol for a Phase 1 study. The objective for conducting the study could be used to determine the
Answer
  • blood levels of acetaminophen in post-partum patients when taken on an empty stomach versus 2 hours after meal consumption
  • therapeutic dosage of test article in reducing soft tissue inflammation following third molar extractions
  • safety and efficacy of chemotherapy agent "x"versus placebo in alleviating pain in osteoarthritis patients
  • therapeutic dosages at which caffeine enhances acetylsalicylic acid absorption in normal, healthy volunteers

Question 73

Question
The sponsor provides a sample informed consent form to potential study sites in order to
Answer
  • fulfill the FDA obligation
  • document the appropriate consent content
  • satisfy the investigators demands
  • inform the IRB/IEC of the correct version

Question 74

Question
The 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
Answer
  • $15,000
  • $13,500
  • $12,000
  • $15,500

Question 75

Question
When reviewing a protocol, the schedule of study events would most likely be presented
Answer
  • in the protocol text and as a table appended to the protocol
  • in the protocol text and by referring to the events section of the study manual
  • by referring to the events section of the study manual and using a patient schedule of visits
  • as a table appended to the protocol and using a patient schedule of visits

Question 76

Question
Which of the following are considered tasks that the CRC would complete prior to the next routine monitoring visit ?
Answer
  • reviewthe CRF to ensure all data has been transcribed and send the original CRF pages to the CRA for review
  • Review the CRF to ensure all data to date has been transcribed and record investigational product dispensation completed to date
  • Enter all projected visit dates on the enrollment log and send the original CRF pages to the CRA for review
  • Enter all projected visit dates on the enrollment log and record investigational product dispensation completed to date

Question 77

Question
Which of the following Tasks should A CRC complete prior to the enrollment of subjects?
Answer
  • coordinate the process for completion of study-related procedures and tests
  • discontinue all excluded medications for potential subjects
  • conduct initial protocol training with site Staff
  • inform primary care physician of subjects interest in the study

Question 78

Question
A 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?
Answer
  • Get the subjects's permission and then break the blind
  • Do not break the blind and have the PI call the primary care physician
  • Get the PI's permission and then break the blind
  • Do not break the blind, but immediately notify the IRB/IEC of the request

Question 79

Question
During 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
Answer
  • renal
  • hepatic
  • immunologic
  • dermatological

Question 80

Question
A 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?
Answer
  • ask the investigator if the blood pressure procedure outlined in the protocol is being followed
  • Notify data management department that the CRF entries are incorrect and may need to be queried
  • Contact the medical monitor to discuss closing the site due to 10 protocol violations
  • contact the medical monitor to report the investigator is non-compliant with the protocol
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