question paper pv

8/4/2019 Question Paper PV

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CASE STUDY 1

A subject enrolled in a Phase 3, randomized, double-blind, placebo-controlled clinical trialevaluating the safety and efficacy of a investigational anti-inflammatory agent formanagement of osteoarthritis.

The subject develops severe abdominal pain and nausea one month after randomization.

Subsequent medical evaluation reveals gastric ulcers. The IRB-approved protocol andinformed consent document indicated that there was a 10% chance of developing mild tomoderate gastritis and a 2% chance of developing gastric ulcers for subjects assigned to theactive investigational agent.

The investigator concludes that the subjects gastric ulcers resulted from the researchintervention and withdraws the subject from the study.

Is this an expected or unexpected AE

Should this event/problem be reported to the IRB, Sponsor, Regulatory Authority

What will be the responsibilitiesof the CRC and CRA in this case

CASE STUDY 2

As a result of a processing error by a pharmacy technician, a subject enrolled in a multicenterclinical trial receives a dose of an experimental agent that is 10-times higher than thedose dictated by the IRB-approved protocol.

While the dosing error increased the risk of toxic manifestations of the experimental agent,the subject experienced no detectable harm or adverse effect after an appropriate period ofcareful observation.

Are you going to report this event?if yes, then to whom?Measures for addressing this kind of issues?

CASE STUDY 3

A subject with seizures enrolls in a randomized, Phase 3 clinical trial comparing a newinvestigational anti-seizure agent to a standard, FDA-approved anti-seizure medication.The subject is randomized to the group receiving the investigational agent. One monthafter enrollment, the subject is hospitalized with severe fatigue and on further evaluationis noted to have severe anemia.

The known risk profile of the investigational drug does not include anemia, and the IRB-approved protocol and informed consent document for the study do not identify anemia as arisk of the research.

Is this a labelled/unlabelled//listed/unlisted AE?

Are you going to report this event?if yes, Explain how reporting is done in this case


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CASE STUDY 4

An investigator conducting behavioral research collects individually identifiable sensitiveinformation about illicit drug use and other illegal behaviors by surveying collegestudents. The data are stored on a laptop computer without encryption, and the laptopcomputer is stolen from the investigators car on the way home from work.

Is this event has to be reported? Justify your answer

CASE STUDY 5

A subject with multiple myeloma participates in a phase 3, randomized, double-blind,controlled clinical trial comparing a new chemotherapy agent combined with the currentstandard chemo regimen versus placebo combined with the Current standard chemoregimen. The subject develops neutropenia, sepsis, and then dies.Prolonged bone marrow suppression resulting in neutropenia is a known complication of thechemo regimens and these risks are described in the IC.

Answer the following:Is it unexpected or expected?To whom you are going to report this eventDocuments required and to be maintainedResponsibilities of the Investigator and CRC

CASE STUDY 6Subjects with cancer and enrolled in a phase 2 clinical trial evaluating an investigationalbiologic product derived from human serum. After several subjects are enrolled, a study auditreveals that the investigational product administered to subjects was obtained from donors

who were not appropriately tested for several potential viral contaminants, including HIV andHepatitis B.

Is this unexpected?Is it related to participation in the research?Does it place the subjects and others at greater risk of harm?A patient participated in a clinical trial, he was having mild asthma and after some time he gothospitalized because he develops severe asthma.

MCQ1. Which of the following can not be classified as SAE

1. Inpatient hospitalization or prolongation of existing hospitalization during theperiod of protocol defined surveillance

2. Carcinogenicity3. Congenital anomaly or birth defect4. Persistent or significant disability/incapacity


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2. Which of the following statement is true for Severe AE1. Severity is associated with intensity2. Severity is always associated with hospitalization3. all of the above4. none of the above

3. What is the timeline for the sponsor to report a SUSAR which prolongs hospitalisation?

1. Immediately2. 7 days3. 15 days4. In the annual safety report

4. According to ICH GCP what is the timeline for an investigator to report a SAE to thesponsor?1. Immediately2. 24 hours3. 07 days4. at the next monitoring visit

5. Which of the following is required for documenting SAE:1. Adverse Event Case Report Form2. Source documents3. Principal Investigator (or other designated investigator) must sign SAE report.4. All of the above

6. A patient in a clinical trial met with an accident in which his legs were broken - is it anSAE?1. No2. Yes3. Yes if he stayed in hospital overnight or had serious complications4. Only if he withdrew from the study

7. Who decides whether an AE is related to the study drug or not?1. The investigator2. The investigator, but the Medical Adviser can downgrade the causality, i.e. say it's

not related.3. The investigator but the Medical adviser can upgrade it, i.e. say it is related.4. Anyone on the study team can report causality

8. What is the definition of "unexpected" in terms of ADRs1. Never seen before2. not expected by the sponsor/investigator3. not expected by the patient4. not reported in any literature

A thin 9 year old girl, Mamta, is consented,enrolled and is having her blood drawn using a 21gauge needle attached to a vacutainer. The startled child screams and moves,dislodging theneedle. Pressure is immediately applied, but a hematoma results. Distal pulses are intact,there is no cyanosis, and movement of the extremities unimpairedIs this AE, SAE, SSAR, SUSAR. Justify your AnswerWrite in brief about the role of different stakeholders?

A thin 9 year old girl, Mamta, is consented,enrolled and is having her blood drawn using a 21gauge needle attached to a vacutainer. The startled child screams and moves,dislodging the


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needle. Pressure is immediately applied, but a hematoma results. Distal pulses are intact,there is no cyanosis, and movement of the extremities unimpaired. After 5 days her broughther back to the doctor she was suffering from fever and severe infection. She washospitalized and medication has been started.What will be the role of Sponsor, Investigator and Clinical Research Co-ordinator

What is expedited reporting? Who is responsible for sending this report to the regulatoryauthority

Write about CIOMS II and VDefine prevalence and incidence