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tablets Flashcards

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1
Q

What is the role of the expert committee in examining cases of Serious Adverse Events (SAE) of death?

A

The expert committee examines the report of the SAE and makes recommendations to the CLA within 60 days from receipt of the report.

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2
Q

What must the expert committee consider when examining an SAE of death?

A

Reports of the investigator, sponsor, and the Ethics Committee.

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3
Q

What is the time frame for the CLA to determine the cause of death related to a clinical trial?

A

90 days after considering the expert committee’s recommendations.

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4
Q

What is the sponsor required to do after receiving the CLA’s order regarding compensation?

A

Pay compensation within 30 days.

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5
Q

What must the sponsor and investigator do after an SAE occurs?

A

Forward their reports after analysis to the CLA and the head of the institution within 14 days.

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6
Q

What is the time frame for the Ethics Committee to forward its report on SAE of permanent disability?

A

Within 30 days of the SAE.

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7
Q

What may the CLA do if it considers it necessary when determining the cause of an injury from an SAE?

A

Constitute an independent expert committee.

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8
Q

What is the maximum time period within which the CLA must decide on compensation for clinical trial-related injuries?

A

90 days of receipt of the SAE report.

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9
Q

What is required for a clinical trial to be reviewed by an Ethics Committee?

A

At least five members must be present.

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10
Q

Who should be included in the Ethics Committee for a clinical trial?

A

A medical scientist, clinician, legal expert, social scientist, and lay person.

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11
Q

What must an Ethics Committee do if it rejects a clinical trial protocol?

A

Indicate the reasons in writing and provide a copy to the CLA.

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12
Q

What is the validity period for the registration of an Ethics Committee?

A

Five years.

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13
Q

What is the responsibility of the clinical trial sponsor regarding quality assurance?

A

Implement and maintain quality assurance systems compliant with protocols and GCP Guidelines.

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14
Q

What must sponsors submit if a study is prematurely discontinued?

A

A summary report within 3 months.

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15
Q

What is the timeline for the investigator to report an SAE?

A

Within 24 hours to CLA, sponsor, and Ethics Committee.

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16
Q

What must be included in the informed consent process provided by the investigator?

A

Essential elements of the clinical trial and the subject’s right to claim compensation.

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17
Q

What is the purpose of stability testing for new drugs?

A

To provide evidence on how the quality of a drug varies with time under various environmental factors.

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18
Q

What attributes should stability studies cover for drug substances?

A
  • Physical
  • Chemical
  • Biological
  • Microbiological attributes
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19
Q

What are the general storage conditions for long-term stability studies?

A

30°C ± 2° C/75% RH ± 5% RH.

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20
Q

What is a double-blind study?

A

Both participants and study staff are unaware of the treatment assignment.

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21
Q

What is the definition of unblinding in clinical trials?

A

Disclosure of which treatment the participant received.

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22
Q

What is required for a clinical trial to have the approval of a Registered Ethics Committee?

A

Application for registration with the Central Licensing Authority.

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23
Q

What is the minimum number of members required in an Ethics Committee for clinical trials?

A

Seven members.

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24
Q

What must stability studies for drug substances be conducted in?

A

The same container-closure system proposed for storage and distribution.

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25
What does the term 'stress testing' refer to in the context of drug substances?
Testing to identify the likely degradation products and establish degradation pathways.
26
Fill in the blank: The investigator must report all SAE to the CLA, the sponsor, and the _______.
Ethics Committee.
27
True or False: The Ethics Committee can suspend a clinical trial if it compromises the safety of trial subjects.
True.
28
What must the Ethics Committee analyze and report on if a serious adverse event occurs?
Relevant documents pertaining to the event.
29
What is the duration of accelerated stability testing?
12 months
30
What conditions are maintained during accelerated stability testing?
25°C ± 2° C/60% RH ± 5% RH
31
What is required from study subjects in all trials?
Freely given, informed, written consent
32
What must the investigator provide to study subjects?
Information about the study verbally and using a patient information sheet
33
What document is used to obtain written consent from study subjects?
Informed Consent Form
34
Who must approve the patient information sheet and informed consent form?
Ethics Committee
35
What should be done if changes are made to informed consent documents?
Changes must be approved by the ethics committee and submitted to the Central Licensing Authority
36
Who can provide informed consent if the subject is unable to do so?
A legally acceptable representative
37
What is the role of an impartial witness in the informed consent process?
To be present and append their signature if the subject cannot read or write
38
What is required for pediatric subjects in clinical trials?
Written informed consent from the parent or legal guardian
39
What should investigators do for vulnerable subjects in clinical trials?
Maintain an audio-video recording of the informed consent process
40
When should pediatric studies be conducted?
When the new drug has potential for use in pediatric patients
41
What types of studies should pediatric studies include?
* Clinical trials * Relative bioequivalence comparisons * Definitive pharmacokinetic studies
42
When should pregnant or nursing women be included in clinical trials?
When the drug is intended for use by them or where data from non-pregnant women is unsuitable
43
What follow-up data is required for new drugs intended for use during pregnancy?
Data on pregnancy, foetus, and child
44
What should be examined regarding drug excretion for nursing mothers?
Excretion of the drug or its metabolites into human milk
45
What is the definition of a 'new chemical entity'?
Any substance not approved for marketing as a drug by any drug regulatory authority
46
What does 'orphan drug' refer to?
A drug intended to treat a condition affecting not more than five lakh persons in India
47
What is a 'pharmaceutical formulation'?
Any preparation containing one or more active pharmaceutical ingredients for human or veterinary use
48
What is pharmacovigilance?
The science relating to detection, assessment, understanding, and prevention of adverse effects
49
What is a 'placebo'?
An inactive substance visually identical to a drug being tested
50
What does 'clinical trial protocol' refer to?
A document containing background, objective, design, and methodology for a clinical trial
51
What is the role of an Ethics Committee?
To review and approve trial protocols to safeguard the rights and well-being of trial subjects
52
What is a 'global clinical trial'?
A clinical trial conducted as part of drug development in more than one country
53
What is an 'investigational new drug'?
A new chemical or biological entity not approved for marketing as a drug
54
What is an 'active pharmaceutical ingredient'?
Any substance used in a pharmaceutical formulation to provide pharmacological activity
55
What constitutes an 'adverse event'?
Any untoward medical occurrence during treatment with an investigational drug
56
What is a 'bioavailability study'?
A study assessing the rate and extent to which a drug is absorbed from a formulation
57
What defines a 'bioequivalence study'?
A study to establish the absence of significant differences in absorption rates of a drug
58
What does 'post-trial access' mean?
Making a new drug available to a trial subject after completion of the clinical trial
59
What is a 'serious adverse event'?
An untoward medical occurrence resulting in death, disability, or hospitalization
60
What is the definition of a 'trial subject'?
A person who is either a patient or healthy individual administered an investigational product
61
What is the primary objective of a clinical trial?
To clearly state the exploratory or confirmatory characterization of safety and efficacy
62
What is required for a clinical trial to be conducted legally?
Permission from the Central Licensing Authority and approval from the Ethics Committee
63
What are the phases of clinical trials?
* Phase I * Phase II * Phase III * Phase IV
64
What is the focus of Phase IV clinical trials?
Post-marketing surveillance to detect adverse effects not encountered in earlier phases
65
What is the aim of Phase III clinical trials?
To confirm therapeutic benefits and provide an adequate basis for marketing approval
66
What is the primary objective of Phase III clinical trials?
Demonstration or confirmation of therapeutic benefits ## Footnote Phase III studies aim to confirm preliminary evidence from Phase II regarding the safety and efficacy of a drug.
67
What types of relationships are explored in Phase III studies?
Dose-response relationships ## Footnote This includes relationships among dose, drug concentration in blood, and clinical response.
68
What is the typical subject range in Phase III trials?
Several hundreds to about 3000 subjects ## Footnote Phase III trials evaluate safety and efficacy across larger populations.
69
What is the main goal of Phase II clinical trials?
Evaluate the effectiveness of a drug for specific indications ## Footnote Phase II trials assess common short-term side effects and risks.
70
What is the typical subject range in Phase II studies?
A few dozen to about 300 subjects ## Footnote Phase II involves a limited number of patients for specific disease treatment.
71
What is the primary focus of Phase I clinical trials?
Estimation of safety and tolerability ## Footnote Phase I studies often have non-therapeutic objectives.
72
What is the typical subject range in Phase I studies?
Typically ranges from 20 to 80 subjects ## Footnote Phase I trials focus on drug toxicity, metabolism, absorption, and elimination.
73
What must a sponsor provide in case of trial-related injury or death?
Financial compensation to legal heirs ## Footnote This is in addition to any medical management expenses incurred.
74
What is the responsibility of the ethics committee in clinical trials?
Safeguard the rights, safety, and well-being of trial subjects ## Footnote They must protect vulnerable subjects and maintain documented procedures.
75
What should happen if an ethics committee revokes approval of a trial protocol?
Record reasons for the revocation and communicate to the investigator and Central Licensing Authority ## Footnote This ensures transparency and accountability in clinical trials.
76
What must be reported within 24 hours in case of serious adverse events (SAE)?
All serious adverse events must be reported to CLA, the sponsor, and the Ethics Committee ## Footnote Failure to report requires justification for the delay.
77
What is the sponsor's responsibility regarding medical management during a clinical trial?
Provide free medical management for injured subjects ## Footnote This continues until the injury is determined not to be related to the trial.
78
Fill in the blank: Phase II studies should be conducted in a group of patients selected by _______.
Relatively narrow criteria
79
True or False: Phase I trials typically involve patients with the condition being studied.
False ## Footnote Phase I trials often involve healthy subjects or certain types of patients.
80
What is a key objective of Phase I studies concerning drug dosing?
Determine the maximum tolerated dose ## Footnote This helps establish tolerability needed for later clinical studies.
81
What are the additional objectives of Phase II studies?
Evaluation of potential study endpoints, therapeutic regimens, and target populations ## Footnote These objectives may include exploratory analyses and multiple endpoints.
82
What must be done if the sponsor fails to provide medical management during a trial?
CLA may suspend or cancel the clinical trial ## Footnote This action is taken after affording an opportunity for the sponsor to be heard.
83
What can lead to injury or permanent disability related to clinical trials?
Adverse effects of the investigational product or violations of the approved protocol ## Footnote Additional factors include scientific misconduct or negligence by the sponsor or investigator.
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