CRC Situational Analysis Flashcards by Nicki Kauffman

The costs of a clinical trial are apportioned so that the following procedure will be reimbursed:
a) One MRI at $100
b) Lab tests for the initial visit $50
c) One ECG at $50

A patient undergoing three visits each with an MRI, lab tests, and an ECG would-be liable for:

a) $200
b) $300
c) $400
d) $500

c) $400

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During a monitoring visit the monitor would do all of the following except:

a) Review discrepancies in CRFs and source documents with the Pl or CRC
b) Review informed consent forms signed by new enrollees
c) Ask for updates on the Pl’s conflict of interest
d) Update the regulatory document binder

c) Ask for updates on the Pl’s conflict of interest

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For a subject who has had a consent form emailed to him the CRC should ensure all except:

a) The subject brings the consent form to the conference
b) Supply a new consent form if the subject has forgotten to bring the consent form with him
c) Assume that the subject has read and understood the form
d) Have the subject sign and date the form while the CRC is present

c) Assume that the subject has read and understood the form

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A monitor assessing drug accountability makes a note of the following:
• The sponsor has mailed 50 vials to the site research pharmacist
• Thirty vials were dispensed to patients
• Of the ones dispensed 20 were used

The number of vials eligible for drug destruction is:

a) 10
b) 20
c) 30
d) 40

c) 30

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The subject’s weight in his medical record is reported at 150 Ibs. What would be his approximate weight in kg?

a) 175 kg
b) 100kg
c) 75kg
d) 35 kg

c) 75kg

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A subject on a test drug for allergic rhinitis, reports to the CRC that he was hospitalized for respiratory distress because the test drug is not working. The CRC should immediately inform:

a) The sponsor
b) The PI
c) The IRB
d) The regulatory agency

b) The PI

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A subject on a test drug experiences a hospitalization while on the drug for a period of four weeks at a hospital other than the site’s hospital. The CRC learns of it though a family member. The CRC should report it immediately to:

a) The sponsor
b) The IRB
c) The regulatory agency
d) The relevant family members

a) The sponsor

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The inclusion criterion for a clinical trial sates that the subject should not have a liver or renal function test outside the normal range. His values are:
AST 20
ALT 10
Serum creatinine 2.0

The subject should:

a) Not be enrolled in the clinical trial at the time of presentation
b) Be enrolled in a clinical trial
c) Should be evaluated in another month to see if the lab values were stable
d) Should be evaluated clinically by the Pl

a) Not be enrolled in the clinical trial at the time of presentation

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In order to increase the enrollment number of sites in a clinical trial was doubled. The Pl when notified should:

a) Share the information with the research team
b) File and amendment with the IRB
c) Update the consent form and ask the sponsor, if reconsent of enrolled subjects is required
d) b and c

d) b and c

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A sponsor investigator of a clinical trial increases the number of sites to enhance enrollment. The sponsor investigator should:

a) Inform the IRB
b) Arrange for monitoring of the added sites
c) Arrange for the new sites to be updated on any new findings and IND safety reports
d) All of the above

d) All of the above

a) Inform the IRB
b) Arrange for monitoring of the added sites
c) Arrange for the new sites to be updated on any new findings and IND safety reports

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In screening for eligibility for a clinical trial, 50 medical records were screened. Of these, 50% were screened failures. Of the remaining 10 failed the lab tests at visit 0. The number who proceeded to be evaluable is:

a) 30
b) 15
c) 10
d) 5

b) 15

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A patient in a rheumatoid arthritis clinical trial is required to keep a pain and symptom diary. Which of the following measures would be considered objective in evaluating the trial’s efficacy variable:

a) Number of sleepless nights due to joint pain
b) Ability to go for a run
c) Number of days off work
d) Measures using tape of swelling size in key joints

d) Measures using tape of swelling size in key joints

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A CRC wishes to be ready for potential enrollment into a clinical trial. The study application is still under review with the IRB. In this situation the most that he can do is:

a) Call potential subjects and discuss enrollment
b) Review the proposed informed consent form with potential subjects
c) Review the medical records of potential subjects for eligibility
d) Review the Pl’s previous list of treated subjects to assess if enrollment targets will be met

d) Review the Pl’s previous list of treated subjects to assess if enrollment targets will be met

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A CRC is preparing a project tracker for following the progress of enrolled subjects in a clinical trial for study initiation to study close out. He should follow:

a) The protocol
b) The enrollment log
c) The schedule of assessments
d) The screening log

c) The schedule of assessments

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A subject in a clinical trial experiences severe diarrhea, which requires hospitalization an event not described in the investigator’s brochure. The event is:

a) Not serious because it is not life threatening
b) Expected by the Pl and not reportable to the IRB
c) Unexpected and serious and should be reported to the IRB
d) Should be reported as an adverse event to the sponsor, but not the IRB.

c) Unexpected and serious and should be reported to the IRB

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A subject in a clinical trial is late for a critical visit scheduled for the study. The CRC should:

a) Reschedule the visit immediately
b) Inform the sponsor prior to rescheduling the visit
c) Inform the IRB
d) Immediately report the event as an SAE.

b) Inform the sponsor prior to rescheduling the visit

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The serum creatinine values for a subject on three consecutive visits are 1.6, 1.4, and 1.2. The mean value which can be used to determine if the subject should proceed in the clinical trial is:

a) 1.1
b) 1.3
c) 1.4
d) 1.5

c) 1.4

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A subject being screened for a clinical trial of a drug for allergic rhinitis presents with a heart rate of 110 beats per minute. Tachycardia is not an exclusion criterion for the study. The CRC should:

a) Ask the sponsor’s medical safety officer if the subject should be enrolled
b) Do a repeat measurement of heart rate, in two weeks or more, to see if the symptom is repeatable
c) Ask the subject if he has experienced any symptoms of a rapid heart beat
d) All of the above

d) All of the above

In doing a note to the informed consent the CRC should record:

a) If an interpreter was present and information about the interpreter
b) The date, time ,place and duration of the consent process
c) The use of a witness or legal guardian
d) The fact that all queries were answered and no procedures initiated prior to the conference
e) All of the above

e) All of the above

The sponsor changes the eligibility criteria for an IRB approved protocol and adds a QOL questionnaire. The Pl should submit the following to the IRB:

a) An amendment application
b) The modified protocol
c) The altered investigator’s brochure that triggered the change
d) A revised consent form
e) All of the above

e) All of the above

a) An amendment application
b) The modified protocol
c) The altered investigator’s brochure that triggered the change
d) A revised consent form

During the course of a clinical trial, the CRC notices that the Hct values have been consistently low in several subjects. Upon further investigation it was discovered that the lab assistant was storing the samples under his desk and sending the entire batch for analysis once every week. The CRC should

a) Immediately inform the PI
b) File a protocol deviation with the IRB
c) Inform the sponsor
d) Arrange to have the lab assistant retrained or disciplined
e) Initiate a CAPA plan
f) All of the above

f) All of the above

a) Immediately inform the PI
b) File a protocol deviation with the IRB
c) Inform the sponsor
d) Arrange to have the lab assistant retrained or disciplined
e) Initiate a CAPA plan

In a clinical trial for an oral anti-inflammatory drug the CRC notices that the patients have consistently misunderstood the instructions to take the drug. The CRC should:

a) Investigate who has been doing the informed consent conferences
b) Arrange to retrain the individuals administering consent
c) Reconsent the subjects
d) All of the above

d) All of the above

a) Investigate who has been doing the informed consent conferences
b) Arrange to retrain the individuals administering consent
c) Reconsent the subjects

The requirements for a screening consent would be indicated for all of the following except:

a) Obtaining information about demographics, medical history and lab tests for the subject
b) Conducting a CT scan prior to progression in the clinical trial
c) Initiating a washout of current drug treatments
d) Administering a diagnostic drug for a thyroid condition

a) Obtaining information about demographics, medical history and lab tests for the subject

A subject has to take his medication twice a day and is given a pill box with a counter to assess compliance for the week. The pill count at the end of the week shows one tablet left on Monday, Tuesday, Wednesday, Thursday and Friday and two pills left on Saturday. The compliance rate is:

a) 20%
b) 40%
c) 50%
d) 80%

c) 50%

A CRC has scheduled a first visit for a subject for an IRB approved study. When the patient arrives the CRC notices that the IRB approval letter is missing a date. The CRC should do all of the following except: a) Reschedule the visit b) Contact the IRB and ask for a dated letter c) Inform the PI d) File an unanticipated event report with the IRB*

d) File an unanticipated event report with the IRB*

A phase I oncology study for lymphoma in children should enroll: a) Healthy adults b) Healthy children c) Children with any known cancer d) Children with lymphoma who have failed standard treatment

d) Children with lymphoma who have failed standard treatment

Which of the following statements regarding informed consent are true? a) The consent form should have a signature and date of the subject and the person obtaining consent b) The source documents or note to the informed consent should document that consent was obtained prior to the trial related procedures c) Where the informed consent is administered in an emergency stetting both the date as well as the time of the consent relative to the first trial related procedure should be documented d) All of the above

d) All of the above a) The consent form should have a signature and date of the subject and the person obtaining consent b) The source documents or note to the informed consent should document that consent was obtained prior to the trial related procedures c) Where the informed consent is administered in an emergency stetting both the date as well as the time of the consent relative to the first trial related procedure should be documented

The monitoring of blood pressure prior to taking the drug is required in a clinical trial. The CRC notices that the blood pressure readings have been recording abnormally low blood pressures and suspects the blood pressure monitors may not be adequate. The CRC should: a) Notify the sponsor b) First notify the Pl c) Notify the IRB by filing a protocol deviation d) All of the above

d) All of the above a) Notify the sponsor b) First notify the Pl c) Notify the IRB by filing a protocol deviation

The sponsor's SOP requires the PI to be present for a site initiation visit but scheduling prevents the Pl form being present for the date set by the sponsor. The CRC should: a) Sign for the PI b) Proceed with the site initiation visit c) Schedule the meeting and subsequently train the PI himself d) Reschedule the meeting

d) Reschedule the meeting

During the informed consent process the Pl receives an emergency call from a patient and has to curtail the conference. The CRC should: a) Ask the subject to sign the consent as most of the conference was conducted b) Take over the conference himself and complete it c) Ask the subject to take the consent form with him and bring it back for another scheduled consent conference d) Report the incident as a protocol deviation to the IRB.

c) Ask the subject to take the consent form with him and bring it back for another scheduled consent conference

During a clinical trial the Pl has to leave the country to take care of a relative abroad. The CRC should: a) Make sure either the co-investigator or sub investigator takes over for the Pl per written instructions from the Pl b) Update the delegation log to reflect the new situation c) File and amendment with the IRB indicating a temporary change of personnel d) All of the above

d) All of the above a) Make sure either the co-investigator or sub investigator takes over for the Pl per written instructions from the Pl b) Update the delegation log to reflect the new situation c) File and amendment with the IRB indicating a temporary change of personnel

A subject being consented for a clinical trial is blind. The CRC should: a) Obtain a Braille version of the consent form b) A legally acceptable guardian help the subject sign and the LAR should sign the consent form as well c) Have the complete consent form read to the subject d) All of the above

d) All of the above a) Obtain a Braille version of the consent form b) A legally acceptable guardian help the subject sign and the LAR should sign the consent form as well c) Have the complete consent form read to the subject

Which of the following is a renal function test? a) AST b) ALT c) ALP d) Serum creatinine

d) Serum creatinine

Which of the following is a liver function test? a) AST b) BUN c) Serum Creatinine d) GFR

a) AST

Which of the following is simple test for rheumatoid arthritis or joint disease? a) Erythrocyte Sedimentation Rate b) AST c) Serum creatinine d) Urine microalbumin

a) Erythrocyte Sedimentation Rate

Which of the following is a test for Type Il diabetes? a) Hb A1c b) ALT c) BUN d) Anti-nuclear antigen

a) Hb A1c

A child seven years of age is being consented for a juvenile arthritis clinical trial for a new oral medication. The question that would be important to ask the child would include all of the following except: a) Do you understand juvenile arthritis symptoms and causes b) Do you have difficulty swallowing c) What oral medications have you take before d) Do you prefer to have a liquid formulation

a) Do you understand juvenile arthritis symptoms and causes

A subject in a clinical trial who has been through two earlier visits develops hives and calls the CRC. The CRC should do all of the following except: a) Schedule the subject for an additional visit b) First notify the PI c) Ask the Pl if an SAE report to the IRB is indicated d) Tell the subject that it is not serious

d) Tell the subject that it is not serious

A drug with a half-life of 1 day is initiated at 100mg dose. How much drug would be left in the subject's blood stream after four days? a) 50 mg b) 75 mg c) 35 mg d) 12.5 mg

d) 12.5 mg

A drug with a half-life of one day is initiated at 100mg. The subject does not take the drug for three days. The minimum effective concentration is 50 mg. The maintenance dose that should be administered is: a) 50 mg b) 25 mg c) 75 mg d) 12.5mg

b) 25 mg

The inclusion criteria for a clinical trial indicate that the serum creatinine should not exceed 1.2 mg. A subject repents with a serum creatinine of 1.25 and meets all the other inclusion criteria. The PI feels that the subject is appropriate for the trial. The CRC should: a) First indicate to the Pl that the inclusion criterion has not been met b) Permit the PI to request a medical waiver of eligibility for the subject c) Not consent the subject until the sponsor has approved the medical waiver d) All of the above

d) All of the above a) First indicate to the Pl that the inclusion criterion has not been met b) Permit the PI to request a medical waiver of eligibility for the subject c) Not consent the subject until the sponsor has approved the medical waiver

The appropriate documents to send to the sponsor for a study close out visit include: a) Drug accountability records b) Remaining data clarification forms c) The key to the coded samples d) All of the above

d) All of the above a) Drug accountability records b) Remaining data clarification forms c) The key to the coded samples