Mock All, February 13, 2025
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- Time is limited to only 60mins – count down runs on top of the screen since you have started the test
- You must have to submit before 59mins & test will be locked automatically at 60mins
Once the test locks then will not be unlocked
- You won’t get the results if you couldn’t submit on time, so make sure submitting on time
- Each question carries one mark
- There is no negative marking
Thank you!
1.
In which of the study design participants and the investigator will be unaware of the group to which they were allocated to?
2.
Most of the epidemiological studies applies which of the following study design?
4.
Which of the following is a single largest drug safety data repository in the world?
5.
Which of the following step can be done once the data is complete, accurate, consistent & reliable?
6.
Study conduct phase in CDM includes?
7.
Which of the following study design is planned and designed to answer a research question?
8.
In which of following design Interactive Web Response Systems (IWRS) and Interactive Voice Response Systems (IVRS) techniques can be used?
9.
Which of the following WHO GCP principle talks about Confidentiality/Privacy?
10.
Periodicity of aggregate reports for EMA & DCGI?
11.
Which of the following blinding technique can be typically used in clinical trials to test the safety and efficacy of the drugs?
12.
Good manufacturing practice falls under which ICH guidelines?
13.
Maximum Tolerable Dose (MTD) finding can be used to estimate?
14.
Which is the pre-marketing safety aggregate report?
15.
Naranjio scale method of causality assessment is
16.
Study start-up phase in CDM includes?
17.
Which clinical trial phase called as "therapeutic confirmatory"?
18.
Which of the following is refers to the stopping of the drug, usually after an adverse event (AE) or at the end of a planned treatment?
19.
Which of the following database is maintained by UMC on behalf of World Health Organization?
20.
Which of the following is a regulatory document?
21.
GCP principles comes under which ICH guideline?
22.
Which of the following study design is the most reliable method available for testing new treatments?
23.
Which of the following is not part of the Pharmacovigilance in order to study the safety of medicine?
24.
SAE reconciliation occur between two databases those are?
25.
Identify which is the primary endpoint of Phase 2, 3, 1 & 0 respectively in clinical trials?
26.
Which type of study would most likely be used to identify less common adverse reactions?
27.
“Registration Dossier” for EMEA?
28.
Which clinical trial phase called as "human pharmacology"?
29.
Which of the following is a scientific document?
30.
Which of the following is not part of clinical data management activity?
31.
In which of the following phases of clinical trial of drugs, ethical clearance is not required?
32.
SAD & MAD can be used to calculate?
33.
Glipizide, the oral hypoglycaemic drug acts by:
34.
Study close-out phase in CDM includes?
35.
Lareb is which country's Pharmacovigilance foundation?
36.
Which of the following dictionary is not used in the ICSR processing?
37.
Identify which is correct about Phase 3, 2, 4, & 1 respectively in clinical trials?
38.
“Registration Dossier” for US?
39.
Which of the following ethical principle included the statement that "no experiments should be conducted if it is believed to cause death/disability"?
40.
Which of the following study design become the standard that pharmaceutical companies must meet for calculating and proving the level of efficacy and safety of an experimental drug?
41.
List of approved drugs and their associated IPR is available in ________
42.
Which of the following confirmed values meet the diagnostic threshold for diabetes?
43.
Which of following is not ICSR processing software?
44.
Which country has MHRA as Regulatory Agency?
45.
Common technical document usually represents as?
46.
In which of following design the subject participants are not revealed which group that they have been allocated to. However, the investigator and data analyst will be aware of the allocation of the groups?
47.
In which of the following study design a sample of individuals with the targeted medical condition is given the experimental therapy and then followed over time to observe their response?
48.
Comparison of efficacy of a new drug B with an existing drug A is done in which phase of clinical trials?
49.
Which of the following design is also called as "hypothesis testing studies"?
50.
Good Clinical Practice principles falls under which of the following ICH guidelines?
51.
Which of the following is not the criteria for a valid case?
52.
Which of the following is necessarily have a causal relation with the treatment?
53.
Approval of the NDA should follow?
55.
Which of the following is defined as “any systematic error in the design, conduct or analysis of a study that results in a mistaken estimate of an exposure's effect on the risk of disease”?
56.
Observational studies comes under which phase of the clinical reseach?
57.
Pharmacovigilance programme of India was started by Govt of India on
58.
The most commonly adopted method for reporting of ADR is
59.
Which country uses "MedWatch" safety reporting system?
60.
When a drug is evaluated for its usefulness in controlled conditions, it is termed as a trial signifying:
61.
Which country uses "Yellow card" safety reporting system?
62.
21 CRF part 314 deals with?
63.
Which of the following design is also called as "hypothesis-generating study design"?
64.
Which of the following study design can be used to evaluate an association between an exposure and outcome at the same time?
65.
What is meant by a blind subject?
66.
The reason why haemophilia is more commonly observed in human males than in females is due to
67.
A patient is suspicious of having breast cancer. What type of test will a physician conduct to diagnose the cancer
68.
Eudravigilance is not applicable in which of the following country?
69.
Which of the following is being established in animal studies of NCE?
71.
Which of the following is Pharmacovigilance regulatory agency in Brazil?
72.
Which of the following is a medico-marketing documents?
73.
Which of the following incorporates established ethical and scientific quality standards for the design, conduct, recording and reporting of clinical research involving the participation of human subjects?
74.
Periodicity of aggregate reports for USFDA?
75.
Which of the following is a collection or file of documents that contains all the technical data of pharmaceutical product to be approved or registered or marketed in country?
76.
Processing of pharmacovigilance is
77.
Where was the Kappa variant of COVID first found?
78.
International Conference on Harmonisation (ICH) was created in 1990 as an agreement between the ______________to harmonize different regional requirements for registration of pharmaceutical drug products
79.
Blinding/masking is used in the clinical trials with an aim to?
80.
Which of the following ethical principle included the statement that "human experiments should be based on previous animal experimentation"?
81.
Which is the modern and efficient approach of new drug discovery?
82.
Which of the following WHO GCP principle talks about Benefit-Risk Assessment?
83.
Incidence and prevalence of diseases can studied in?
84.
Module 4 of CTD deals with?
85.
Efficacy of a drug is refers to:
86.
Which of the following studies are more difficult and expensive to design but the results obtained will exclude confounding effects from knowledge of group allocation?
87.
The aim of the post-marketing studies is:
88.
Which clinical research phase called as "real-world setting"?
89.
Release of histamine and leukotrienes from mast cells is prevented by:
90.
Bleeding after anticoagulants is which of the following type of ADR?
91.
Which of the following is refers to the relationship between a treatment drug and the occurrence of an adverse event?
92.
Which of the following data capture method is provides real time access to the data?
93.
Treatment of choice for chronic myeloid leukemia is:
94.
This diabetes drug acts by decreasing the amount of glucose produced by the liver
95.
21 CRF part 312 deals with?
96.
Pharmaceuticals and Medical Devices Agency is which country regulatory agency?
97.
Good pharmacovigilance practices (GVP) guidelines are applicable in which of the following countries?
98.
In which of the following study design investigators can eventually use the data to answer many questions about the associations between "risk factors" and disease outcomes?
99.
Module 5 of CTD deals with?
100.
Which of the following study design compares the outcomes/risk factors between healthy and diseased population?