What are Good Clinical Practices? a. Regulations set in place by Government that how clinical trials are supposed to be managed. b. Clinical practices that adhere to the best standards of care. c. Widely accepted standards of practice during clinical trials d. The FDA’s requirements for how trials are conducted and documented

What are Good Clinical Practices?

a. Regulations set in place by Government that how clinical trials are supposed to be managed.

b. Clinical practices that adhere to the best standards of care.

c. Widely accepted standards of practice during clinical trials

d. The FDA’s requirements for how trials are conducted and documented
by

1 Answer

Answer :

d. The FDA’s requirements for how trials are conducted and documented 
by

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Description : Which of the following statements best describes a lead compound? a) A compound that contains the element lead b) A compound from the research laboratory that is chosen to go forward for preclinical and ... of a drug. d) The first compound of a structural class of compounds to reach the market.

Last Answer : c) A molecule that shows some activity or property of interest and serves as the starting point for the development of a drug.

Average time period for phase II clinical trials study is ___________ a) Upto 4 year b) Upto few month c) Upto Two year d) Upto several year

Description : Average time period for phase II clinical trials study is ___________ a) Upto 4 year b) Upto few month c) Upto Two year d) Upto several year

Last Answer : c) Upto Two year 

Which of the following responsibility of the clinical pharmacist is in direct patient care area? a) Supervision of drug administration techniques. b) Providing drug information to physicians and nurses. c) Identify drugs brought into the hospital by patients. d) Reviewing of each patient’s drug administration forms periodically to ensure all doses have been administered.

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Last Answer : d) Reviewing of each patient’s drug administration forms periodically to ensure all doses have been administered.

GCP are seen in all of the following except a) Phase I trial b) Phase II trial c) Preclinical trials d) Phase IV trial

Description : GCP are seen in all of the following except a) Phase I trial b) Phase II trial c) Preclinical trials d) Phase IV trial

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The overriding objective of the International Auditing Standards that are issued by the International Auditing Practices Committee of the IFAC is a. To override a country’s regulations governing the audit of financial statements. b. To improve the uniformity of auditing practices and related services throughout the world. c. To provide a uniform application of specific audit procedures that are acceptable worldwide. d. To replace generally accepted auditing standards.

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Last Answer : To improve the uniformity of auditing practices and related services throughout the world.

Which is person responsible for the conduct of the clinical trial at a trial site? a) Clinical Research Coordinator b) Monitor c) Investigator d) Sponsor

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Description :  ______________ of clinical trial involves first time human trial in a small number of patients. a Phase I b Phase II c Phase III d Phase IV

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Last Answer : d) Signed document of the recruited patient for the clinical trial procedures 

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The sponsor in clinical study is a) Country. b) Organisation. c) Society. d) Cohort.

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How and why do we compare drugs to standard of care during clinical trials?

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Organogenesis occurs during ______________stage. a) Pre-embryonic. b) Embryonic. c) Pre-Fetal. d) Fetal.

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Last Answer : b) Embryonic. 

___________ is contraindicated during pregnancy due to its Teratogenicity. a) Folic acid b) Calcium c) Retinol d) Iron

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Which of the following statements regarding fibroblasts and their function in wound healing are true? a. IL-1 has both inhibitory and promotional effects on fibroblast growth b. TNFa stimulates fibroblast collagen synthesis c. IL-1 and TNFa have opposite effects on the healing of bone d. In human clinical trials, EGF (epithelial growth factor) has been demonstrated to accelerate epidermal regeneration in cutaneous wounds

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Last Answer : d) A 68 year old patient who has oedema receiving a prescription for a diuretic. 

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Which of the following adverse drug reactions would you report to the Medicines and Healthcare Products regulatory Agency (MHRA) via the yellow card system for reporting? a) A patient reports a skin rash after starting a course on amoxicillin capsules. b) A patient reports experiencing dyspepsia when they take their indomethacin capsules. c) A patient complains of a dry irritating cough since they have started taking ramipril. d) A patient complains they have experienced diarrhoea since taking azilsartan.

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Pharmacovigilance is done for monitoring of a) Drug price b) Unethical practises c) Drug safety d) Pharmacy students

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Last Answer : c) Drug safety 

Which of the following is Type B ADRS? a) Hypoglycaemia caused by Insulin b) Dryness of mouth caused by Atropine c) Anaemia in patient with G6PD deficiency caused by Primaquine d) Hyperglycaemia caused by thiazide diuretics

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Last Answer : c) Anaemia in patient with G6PD deficiency caused by Primaquine 

Which of the following would you classify as a pharmacodynamics interaction? a) ACE inhibitors with potassium-sparing diuretics cause life-threatening hyperkalaemia b) Antacids reduce the absorption of fluoroquinolones c) Increased bleeding due to cimetidine and warfarin d) Probenecid increases half-life of penicillin

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Gary baby syndrome occur in new born with a) Tetracycline b) Chloramphenicol c) Penicillin d) Erythromycin

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Last Answer : c) Motivate the patient to take medicine for improvement of his/her health status. 

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Description : Which of the following drug is not needed to be TDM? a) Carbamazepine. b) Penicillin. c) Digoxin. d) Gentamicin.

Last Answer : b) Penicillin. 

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Which of the following terms does not describe an Adverse Drug Reaction? a) Idiosyncrasy b) Anaphylaxis c) Teratogenic effect d) Placebo effect

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Which of the following is a technique pharmacists can use to humanize themselves to their patients? a) Using the patient's preferred name in conversation b) Delegating as many tasks as possible to an assistant c) Reading the text of a medication bottle verbatim to a patient d) Providing business cards at the desk

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Last Answer : c) Reading the text of a medication bottle verbatim to a patient 

GCP provides public assurance that a) Rights and safety of participants are protected b) The rights, safety and wellbeing of research participants are protected and that research data are reliable. c) Results are reliable d) Safety of participant is observed and results are reliable

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