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CRC certification Quiz on CRC Exam Pre-test 2005, created by cmulvey on 30/07/2014.

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CRC Exam Pre-test 2005

Question 1 of 80

1

Who is responsible for writing and filing the IND safety report to the regulatory authority?

Select one of the following:

  • investigator

  • sponsor

  • IRb/IEC

  • study coordinaor

Explanation

Question 2 of 80

1

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?

Select one of the following:

  • 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

Explanation

Question 3 of 80

1

the investigator must notify the IRB/IEC of an significant new findings during the course of the study when the _________

Select one of the following:

  • 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

Explanation

Question 4 of 80

1

When a subject reports an adverse event, who is responsible for determining its "relationship to the study drug"?

Select one of the following:

  • CRA

  • IRB/IEC

  • Investigator

  • CRC

Explanation

Question 5 of 80

1

A CRA is responsible for which of the following?

Select one of the following:

  • 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

Explanation

Question 6 of 80

1

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?

Select one of the following:

  • 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

Explanation

Question 7 of 80

1

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?

Select one of the following:

  • 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

Explanation

Question 8 of 80

1

When advertising for research subjects in a local newspaper, which of the following are most appropriate to be included?

Select one of the following:

  • 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

Explanation

Question 9 of 80

1

under certain circumstances it may be necessary to disclose Protected Health Information (PHI) without prior written permission of the subject. Those circumstances would be

Select one of the following:

  • insurance company requests

  • family member inquiries

  • non existant

  • medical emergencies

Explanation

Question 10 of 80

1

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

Select one of the following:

  • 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

Explanation

Question 11 of 80

1

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?

Select one of the following:

  • Notify the sponsor within 24 hours

  • Notify the IRB/IEC immediately

  • Document as an AE

  • Document as an SAE

Explanation

Question 12 of 80

1

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?

Select one of the following:

  • 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

Explanation

Question 13 of 80

1

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?

Select one of the following:

  • 68 kg and 165 cm

  • 60 kg and 143 cm

  • 72 kg and 170 cm

  • 75 kg and 180 cm

Explanation

Question 14 of 80

1

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?

Select one of the following:

  • financial disclosure updates

  • screening logs

  • FDA Form 1572

  • IRB/IEC approval

Explanation

Question 15 of 80

1

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?

Select one of the following:

  • financial disclosure updates

  • screening logs

  • FDA Form 1572

  • IRB/IEC approval

Explanation

Question 16 of 80

1

A subjects study-specific flow sheet should be stored with

Select one of the following:

  • medical records

  • regulatory docs

  • drug accountablity

  • source documents

Explanation

Question 17 of 80

1

Which of the following is a BASIC element of informed consent according to the US FDA regulations?

Select one of the following:

  • 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

Explanation

Question 18 of 80

1

When may an investigator break the blind without pre-approval by the sponsor?

Select one of the following:

  • after the study is completed

  • if the subject requests to know

  • if an SAE occurs

  • when study subject safety is jeopardized

Explanation

Question 19 of 80

1

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

Select one of the following:

  • 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

Explanation

Question 20 of 80

1

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

Select one of the following:

  • 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

Explanation

Question 21 of 80

1

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

Select one of the following:

  • 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

Explanation

Question 22 of 80

1

According to ICH, which of the following are considered SAEs?

Select one of the following:

  • 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

Explanation

Question 23 of 80

1

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

Select one of the following:

  • 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

Explanation

Question 24 of 80

1

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

Select one of the following:

  • an adverse drug reaction

  • a serious adverse event

  • an unexpected adverse event

  • a severe adverse event

Explanation

Question 25 of 80

1

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?

Select one of the following:

  • 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

Explanation

Question 26 of 80

1

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?

Select one of the following:

  • 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

Explanation

Question 27 of 80

1

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?

Select one of the following:

  • 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

Explanation

Question 28 of 80

1

A screening procedure that qualifies as minimal risk in a study that is considered to present greater that minimal risk requires

Select one of the following:

  • full consent

  • IRB/IEC acknowledgment

  • screening consent

  • no consent

Explanation

Question 29 of 80

1

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

Select one of the following:

  • blinded control

  • outcome studies

  • randomized

  • stratified

Explanation

Question 30 of 80

1

Recruitment in an osteoporosis study is a site-specific problem. Which of the following is the least likely factor contributiong to recruitment problems?

Select one of the following:

  • 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

Explanation

Question 31 of 80

1

In order to ensure that an investigative site can provide adequate storage space for the test article and study supplies, the sponsor would conduct?

Select one of the following:

  • A telephone conference with the site

  • A pre-study site evalutaion

  • An investigators meeting

  • an initiation visit

Explanation

Question 32 of 80

1

During the initial review of the protocol the CRC has questions about the study procedures. The CRC should do which of the following?

Select one of the following:

  • 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

Explanation

Question 33 of 80

1

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?

Select one of the following:

  • 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

Explanation

Question 34 of 80

1

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?

Select one of the following:

  • 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

Explanation

Question 35 of 80

1

During the course of a clinical study, for which of the following items woldl a sponsor most likely reimburse a site?

Select one of the following:

  • an increase in subject stipend

  • prescriptions ordered during study participation

  • a hospitalization occurring during a study

  • additional visits or tests due to an AE

Explanation

Question 36 of 80

1

During the course of a clinical study, for which of the following items woldl a sponsor most likely reimburse a site?

Select one of the following:

  • an increase in subject stipend

  • prescriptions ordered during study participation

  • a hospitalization occurring during a study

  • additional visits or tests due to an AE

Explanation

Question 37 of 80

1

Which of the following items should be included in the formal close-out report from the site to the IRB/IEC?

Select one of the following:

  • 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,

Explanation

Question 38 of 80

1

Which of the following items should be included in the formal close-out report from the site to the IRB/IEC?

Select one of the following:

  • 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,

Explanation

Question 39 of 80

1

The difference between a short-form informed consent and the regular informed consent is that a short-form

Select one of the following:

  • is a written summary provided to the subject

  • requires two witnesses

  • is presented orally

  • must be signed by the person obtaining consent

Explanation

Question 40 of 80

1

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?

Select one of the following:

  • 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.

Explanation

Question 41 of 80

1

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

Select one of the following:

  • 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

Explanation

Question 42 of 80

1

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

Select one of the following:

  • 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

Explanation

Question 43 of 80

1

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

Select one of the following:

  • a member of the FDA's Drug Information Branch

  • the sponsor

  • an independent physician

  • a sub-investigator listed on the 1572

Explanation

Question 44 of 80

1

in which of the following circumstances would it be acceptable to administer a test article to a pregnant subject?

Select one of the following:

  • She states that she will terminate the pregnacny

  • She has no insurance

  • She is a single parent

  • She has a life-threatening injury

Explanation

Question 45 of 80

1

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?

Select one of the following:

  • 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

Explanation

Question 46 of 80

1

According to the CFR, an unexpected adverse drug experience (ADE) is

Select one of the following:

  • 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

Explanation

Question 47 of 80

1

According to the CFR, an unexpected adverse drug experience (ADE) is

Select one of the following:

  • 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

Explanation

Question 48 of 80

1

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 ?

Select one of the following:

  • 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

Explanation

Question 49 of 80

1

When does a study site become responsible for submitting IND safety reports to the IRB/IEC

Select one of the following:

  • 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

Explanation

Question 50 of 80

1

A subject has been enrolled under an emergency use of an investigational product. Within how many working day should the IRB/IEC be notified?

Select one of the following:

  • 7

  • 1

  • 5

  • 3

Explanation

Question 51 of 80

1

A well-defined clinical study using a placebo to evaluate the reference group is called a/an ____________ clinical trial

Select one of the following:

  • controlled

  • active concurrent controlled

  • parallel

  • crossover

Explanation

Question 52 of 80

1

The main purpose of a a study specific source document checklist is to

Select one of the following:

  • 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

Explanation

Question 53 of 80

1

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?

Select one of the following:

  • 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.

Explanation

Question 54 of 80

1

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

Select one of the following:

  • moderate, possible related and not severe

  • moderate, unrelated and serious

  • severe, probably related and serious

  • mild, unrelated and not serious

Explanation

Question 55 of 80

1

Which of the following might be considered sources in order for determining local laboratory costs?

Select one of the following:

  • 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

Explanation

Question 56 of 80

1

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

Select one of the following:

  • an unexpected AE

  • a primary endpoint

  • a serious adverse event

  • an unexpected outcome

Explanation

Question 57 of 80

1

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?

Select one of the following:

  • 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

Explanation

Question 58 of 80

1

According to the FDA regulations, which of the following is the best example of a vulnerable subject?

Select one of the following:

  • a nun

  • an HMO participant

  • a pregnant woman

  • a long-time patient of the investigator

Explanation

Question 59 of 80

1

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?

Select one of the following:

  • 150

  • 145

  • 143

  • 135

Explanation

Question 60 of 80

1

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

Select one of the following:

  • 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

Explanation

Question 61 of 80

1

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

Select one of the following:

  • informed consent

  • investigational plan

  • study protocol

  • investigator's brochure

Explanation

Question 62 of 80

1

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?

Select one of the following:

  • 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

Explanation

Question 63 of 80

1

If a subject in a long-term, open-label maintenance study requires knee replacement surgery, which of the following is true?

Select one of the following:

  • 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

Explanation

Question 64 of 80

1

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?

Select one of the following:

  • single-blinded

  • open-label

  • crossover

  • placebo-controlled

Explanation

Question 65 of 80

1

Who is ultimately responsible for the proper storage and accountability of the test article?

Select one of the following:

  • CRA

  • PI

  • CRC

  • pharmacist

Explanation

Question 66 of 80

1

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

Select one of the following:

  • 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

Explanation

Question 67 of 80

1

An AE that was not evident during baseline is considered to be

Select one of the following:

  • unexpected

  • a pre-existing condition

  • an un-toward medical event

  • an SAE

Explanation

Question 68 of 80

1

According to CFR, which of the following must the investigator report to the IRB/IEC?

Select one of the following:

  • 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

Explanation

Question 69 of 80

1

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

Select one of the following:

  • drug-related

  • an adverse event

  • a serious adverse event

  • an accident

Explanation

Question 70 of 80

1

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?

Select one of the following:

  • 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

Explanation

Question 71 of 80

1

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

Select one of the following:

  • an adverse event

  • early termination

  • a serious adverse event

  • a side effect

Explanation

Question 72 of 80

1

A CRC is reviewing a protocol for a Phase 1 study. The objective for conducting the study could be used to determine the

Select one of the following:

  • 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

Explanation

Question 73 of 80

1

The sponsor provides a sample informed consent form to potential study sites in order to

Select one of the following:

  • fulfill the FDA obligation

  • document the appropriate consent content

  • satisfy the investigators demands

  • inform the IRB/IEC of the correct version

Explanation

Question 74 of 80

1

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

Select one of the following:

  • $15,000

  • $13,500

  • $12,000

  • $15,500

Explanation

Question 75 of 80

1

When reviewing a protocol, the schedule of study events would most likely be presented

Select one of the following:

  • 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

Explanation

Question 76 of 80

1

Which of the following are considered tasks that the CRC would complete prior to the next routine monitoring visit ?

Select one of the following:

  • 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

Explanation

Question 77 of 80

1

Which of the following Tasks should A CRC complete prior to the enrollment of subjects?

Select one of the following:

  • 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

Explanation

Question 78 of 80

1

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?

Select one of the following:

  • 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

Explanation

Question 79 of 80

1

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

Select one of the following:

  • renal

  • hepatic

  • immunologic

  • dermatological

Explanation

Question 80 of 80

1

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?

Select one of the following:

  • 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

Explanation

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