CASE STUDY 1 A subject enrolled in a Phase 3, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy

of a investigational anti-inflammatory agent for management of osteoarthritis. The subject develops severe abdominal pain and nausea one month after randomization. Subsequent medical evaluation reveals gastric ulcers. The IRB-approved protocol and informed consent document indicated that there was a 10% chance of developing mild to moderate gastritis and a 2% chance of developing gastric ulcers for subjects assigned to the active investigational agent. The investigator concludes that the subjects gastric ulcers resulted from the research intervention 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 multicenter clinical trial receives a dose of an experimental agent that is 10-times higher than the dose 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 of careful 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 new investigational anti-seizure agent to a standard, FDA-approved anti-seizure medication. The subject is randomized to the group receiving the investigational agent. One month after enrollment, the subject is hospitalized with severe fatigue and on further evaluation is noted to have severe anemia. The known risk profile of the investigational drug does not include anemia, and the IRBapproved protocol and informed consent document for the study do not identify anemia as a risk 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

CASE STUDY 4 An investigator conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. The data are stored on a laptop computer without encryption, and the laptop computer 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 current standard chemo regimen versus placebo combined with the Current standard chemo regimen. The subject develops neutropenia, sepsis, and then dies. Prolonged bone marrow suppression resulting in neutropenia is a known complication of the chemo 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 event Documents required and to be maintained Responsibilities of the Investigator and CRC CASE STUDY 6 Subjects with cancer and enrolled in a phase 2 clinical trial evaluating an investigational biologic product derived from human serum. After several subjects are enrolled, a study audit reveals that the investigational product administered to subjects was obtained from donors who were not appropriately tested for several potential viral contaminants, including HIV and Hepatitis 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 got hospitalized because he develops severe asthma. MCQ 1. Which of the following can not be classified as SAE 1. Inpatient hospitalization or prolongation of existing hospitalization during the period of protocol defined surveillance 2. Carcinogenicity 3. Congenital anomaly or birth defect 4. Persistent or significant disability/incapacity

2. Which of the following statement is true for Severe AE 1. Severity is associated with intensity 2. Severity is always associated with hospitalization 3. all of the above 4. none of the above 3. What is the timeline for the sponsor to report a SUSAR which prolongs hospitalisation? 1. Immediately 2. 7 days 3. 15 days 4. In the annual safety report 4. According to ICH GCP what is the timeline for an investigator to report a SAE to the sponsor? 1. Immediately 2. 24 hours 3. 07 days 4. at the next monitoring visit 5. Which of the following is required for documenting SAE: 1. Adverse Event Case Report Form 2. Source documents 3. 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 an SAE? 1. No 2. Yes 3. Yes if he stayed in hospital overnight or had serious complications 4. Only if he withdrew from the study 7. Who decides whether an AE is related to the study drug or not? 1. The investigator 2. 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 ADRs 1. Never seen before 2. not expected by the sponsor/investigator 3. not expected by the patient 4. not reported in any literature A thin 9 year old girl, Mamta, is consented,enrolled and is having her blood drawn using a 21 gauge needle attached to a vacutainer. The startled child screams and moves,dislodging the needle. Pressure is immediately applied, but a hematoma results. Distal pulses are intact, there is no cyanosis, and movement of the extremities unimpaired Is this AE, SAE, SSAR, SUSAR. Justify your Answer Write 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 21 gauge needle attached to a vacutainer. The startled child screams and moves,dislodging the

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 brought her back to the doctor she was suffering from fever and severe infection. She was hospitalized 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 regulatory authority Write about CIOMS II and V Define prevalence and incidence