CP-ACRP Flashcards
What is the primary responsibility of a Clinical Research Coordinator (CRC)?
- A) Designing clinical trial protocols
- B) Conducting statistical analysis of trial data
- C) Overseeing the day-to-day operations of clinical trials
- D) Issuing regulatory approvals for clinical trials
Answer: C) Overseeing the day-to-day operations of clinical trials
Which of the following is an essential document that must be included in the Trial Master File (TMF)?
- A) Investigator’s Brochure
- B) Patient’s personal health records
- C) Researcher’s tax returns
- D) Sponsor’s business plan
Answer: A) Investigator’s Brochure
According to Good Clinical Practice (GCP) guidelines, informed consent must be obtained:
- A) After the clinical trial begins
- B) Before any trial-related procedures are performed
- C) Only if the subject requests it
- D) Only for trials involving high-risk interventions
Answer: B) Before any trial-related procedures are performed
Which regulatory body is primarily responsible for overseeing clinical trials in the United States?
- A) National Institutes of Health (NIH)
- B) Centers for Disease Control and Prevention (CDC)
- C) Food and Drug Administration (FDA)
- D) Department of Health and Human Services (DHHS)
Answer: C) Food and Drug Administration (FDA)**
What is the main purpose of an Institutional Review Board (IRB)?
- A) To provide funding for clinical research
- B) To ensure the safety and rights of research participants
- C) To design clinical trial protocols
- D) To publish research findings
Answer: B) To ensure the safety and rights of research participants
The Declaration of Helsinki is a set of ethical principles regarding:
- A) Laboratory animal research
- B) Data management in clinical trials
- C) Human experimentation and clinical research
- D) Pharmaceutical marketing practices
Answer: C) Human experimentation and clinical research
What is the term used for the document that provides detailed information about the investigational product used in a clinical trial?
- A) Case Report Form (CRF)
- B) Investigator’s Brochure (IB)
- C) Protocol Amendment
- D) Informed Consent Form (ICF)
*Answer: B) Investigator’s Brochure (IB)**
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that:
- A) Is related to the investigational product
- B) Occurs at a higher frequency than expected
- C) Results in death, is life-threatening, requires hospitalization, or causes significant disability
- D) Can be managed by adjusting the dosage of the investigational product
Answer: C) Results in death, is life-threatening, requires hospitalization, or causes significant disability
Which phase of clinical trials is primarily concerned with evaluating the efficacy of a new treatment?
- A) Phase I
- B) Phase II
- C) Phase III
- D) Phase IV
Answer: B) Phase II
In a double-blind study, who is unaware of the treatment assignments?
- A) Only the subjects
- B) Only the investigators
- C) Both the subjects and the investigators
- D) The regulatory authority
Answer: C) Both the subjects and the investigators
What is the main goal of a Data and Safety Monitoring Board (DSMB) in clinical trials?
- A) To promote the trial’s objectives to the public
- B) To ensure the trial is conducted within the budget
- C) To review and monitor data to ensure the safety of participants
- D) To recruit participants for the study
Answer: C) To review and monitor data to ensure the safety of participants
Which document outlines the objectives, design, methodology, statistical considerations, and organization of a clinical trial?
- A) Informed Consent Form (ICF)
- B) Clinical Study Report (CSR)
- C) Protocol
- D) Case Report Form (CRF)
Answer: C) Protocol
When must a deviation from the clinical trial protocol be reported to the IRB/IEC?
- A) Only if it results in a Serious Adverse Event (SAE)
- B) Only at the end of the study
- C) As soon as the deviation is identified
- D) It does not need to be reported
Answer: C) As soon as the deviation is identified
What is the primary purpose of conducting Phase I clinical trials?
- A) To determine the drug’s efficacy in the target population
- B) To evaluate the long-term side effects of the drug
- C) To assess the drug’s safety, tolerability, and pharmacokinetics in healthy volunteers or patients
- D) To compare the new drug with standard treatments
Answer: C) To assess the drug’s safety, tolerability, and pharmacokinetics in healthy volunteers or patients**
Which of the following is true regarding the responsibilities of the Principal Investigator (PI) in a clinical trial?
- A) The PI is responsible for obtaining informed consent from all participants.
- B) The PI delegates all trial-related activities to the study coordinator.
- C) The PI ensures compliance with the protocol, GCP, and applicable regulatory requirements.
- D) The PI is only responsible for data collection.
Answer: C) The PI ensures compliance with the protocol, GCP, and applicable regulatory requirements.
How often should a clinical trial’s progress be reported to the IRB/IEC?
- A) Only at the beginning and end of the study
- B) Annually, or more frequently if requested by the IRB/IEC
- C) Every six months
- D) Only if there are adverse events
Answer: B) Annually, or more frequently if requested by the IRB/IEC
In the context of clinical trials, what does the term “monitoring” refer to?
- A) The process of tracking the study budget
- B) The act of supervising the administrative tasks of the trial
- C) The oversight and administrative efforts that ensure the trial is conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, and applicable regulatory requirements
- D) The recruitment of study participants
*Answer: C) The oversight and administrative efforts that ensure the trial is conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, and applicable regulatory requirements**
What should be done if a research participant decides to withdraw from a clinical trial?
- A) The participant should be asked to return all study-related materials.
- B) The participant’s decision should be respected without any pressure to continue, and their data up to the point of withdrawal should be retained.
- C) The participant should be removed from the study database.
- D) The participant should be penalized for withdrawing.
Answer: B) The participant’s decision should be respected without any pressure to continue, and their data up to the point of withdrawal should be retained.
What is a Case Report Form (CRF) used for in clinical trials?
- A) To document adverse events
- B) To record protocol deviations
- C) To collect data on each trial subject as specified in the protocol
- D) To obtain informed consent
Answer: C) To collect data on each trial subject as specified in the protocol
Which of the following is NOT a key component of Good Clinical Practice (GCP)?
- A) Ensuring the integrity of clinical trial data
- B) Protecting the rights, safety, and well-being of trial subjects
- C) Ensuring compliance with local laws
- D) Guaranteeing a high success rate for the investigational product
Answer: D) Guaranteeing a high success rate for the investigational product
Which of the following best describes the role of a Clinical Research Professional in ensuring participant safety?
- A) Designing the clinical trial protocol
- B) Conducting statistical analysis
- C) Monitoring adverse events and reporting them to the IRB/IEC
- D) Preparing marketing materials for the investigational product
*Answer: C) Monitoring adverse events and reporting them to the IRB/IEC**
The Belmont Report outlines three basic ethical principles for research involving human subjects. Which of the following is NOT one of these principles?
- A) Respect for persons
- B) Beneficence
- C) Justice
- D) Non-maleficence
*Answer: D) Non-maleficence**
Which regulatory document must be reviewed and approved by the Institutional Review Board (IRB) before a clinical trial can begin?
- A) Case Report Form (CRF)
- B) Study Budget
- C) Research Protocol
- D) Statistical Analysis Plan (SAP)
Answer: C) Research Protocol
Which phase of clinical trials primarily focuses on evaluating the safety and dosage of an investigational product?
- A) Phase I
- B) Phase II
- C) Phase III
- D) Phase IV
Answer: A) Phase I
Informed consent is a process that ensures participants:
- A) Are compensated for their time
- B) Understand the risks and benefits of the study
- C) Are enrolled in the study regardless of their willingness
- D) Have their medical records published
*Answer: B) Understand the risks and benefits of the study**
Which of the following is a responsibility of the Data Safety Monitoring Board (DSMB)?
- A) Recruiting participants for the study
- B) Approving the clinical trial protocol
- C) Monitoring data for participant safety
- D) Auditing financial records of the study
*Answer: C) Monitoring data for participant safety**
According to ICH-GCP guidelines, how long should essential documents be retained after the completion of a clinical trial?
- A) 2 years
- B) 5 years
- C) 10 years
- D) As specified by regulatory requirements
Answer: D) As specified by regulatory requirements**
Which of the following is an example of a vulnerable population in clinical research?
- A) Healthy adults
- B) Elderly individuals
- C) Pregnant women
- D) Athletes
*Answer: C) Pregnant women**
What is the primary goal of conducting Phase III clinical trials?
- A) To test the drug’s effectiveness in a large group of patients
- B) To identify side effects and risks
- C) To explore pharmacokinetics and pharmacodynamics
- D) To conduct post-marketing surveillance
*Answer: A) To test the drug’s effectiveness in a large group of patients**
Which document is used to collect data on each trial subject as specified in the protocol?
- A) Investigator’s Brochure (IB)
- B) Case Report Form (CRF)
- C) Informed Consent Form (ICF)
- D) Adverse Event Report (AER)
Answer: B) Case Report Form (CRF)
What is the primary purpose of an Institutional Review Board (IRB)?
- A) To provide funding for clinical research
- B) To protect the rights and welfare of human research subjects
- C) To design clinical trial protocols
- D) To publish research findings
Answer: B) To protect the rights and welfare of human research subjects
Which of the following best describes the term “monitoring” in the context of clinical research?
- A) Overseeing the financial aspects of a study
- B) Tracking patient enrollment numbers
- C) Ensuring that the trial is conducted in compliance with the protocol and regulatory requirements
- D) Designing the statistical analysis plan
Answer: C) Ensuring that the trial is conducted in compliance with the protocol and regulatory requirements
Question 13
Which ethical principle requires that research subjects voluntarily consent to participate in a clinical trial after being fully informed of the risks, benefits, and alternatives?
- A) Beneficence
- B) Autonomy
- C) Justice
- D) Non-maleficence
Answer: B) Autonomy
Question 14
Which of the following is NOT typically included in a clinical trial protocol?
- A) Study objectives
- B) Data collection methods
- C) Detailed marketing strategy
- D) Inclusion and exclusion criteria
Answer: C) Detailed marketing strategy
Question 15
Which of the following is a key responsibility of the Principal Investigator (PI) in a clinical trial?
- A) Ensuring the investigational product is marketed effectively
- B) Delegating all trial-related tasks to the study coordinator
- C) Ensuring compliance with the protocol, GCP, and applicable regulations
- D) Preparing the study’s financial budget
Answer: C) Ensuring compliance with the protocol, GCP, and applicable regulations
Question 16
What is the main purpose of a Clinical Study Report (CSR)?
- A) To recruit study participants
- B) To detail the final results and interpretation of a clinical trial
- C) To outline the budget and financial aspects of the study
- D) To obtain IRB approval
Answer: B) To detail the final results and interpretation of a clinical trial
Question 17
Which phase of clinical trials is primarily concerned with post-marketing surveillance to monitor the long-term effects of an approved drug?
- A) Phase I
- B) Phase II
- C) Phase III
- D) Phase IV
Answer: D) Phase IV
Question 18
The term “adverse event” (AE) in clinical research refers to:
- A) Any positive outcome from the investigational product
- B) A negative reaction to the investigational product that occurs in more than 50% of subjects
- C) Any untoward medical occurrence in a participant, which may or may not be related to the investigational product
- D) Only severe reactions that require hospitalization
Answer: C) Any untoward medical occurrence in a participant, which may or may not be related to the investigational product
Question 19
Who is responsible for ensuring that the clinical trial data is accurate, complete, and verifiable from source documents?
- A) The study sponsor
- B) The Clinical Research Coordinator (CRC)
- C) The Data Safety Monitoring Board (DSMB)
- D) The clinical trial monitor
Answer: D) The clinical trial monitor
What must be done if a research participant experiences a Serious Adverse Event (SAE) during a clinical trial?
- A) The SAE must be reported to the IRB/IEC and the sponsor immediately.
- B) The SAE should be documented but not reported unless it leads to study discontinuation.
- C) The participant should be withdrawn from the study immediately.
- D) The SAE should be reported to regulatory authorities only after the study ends.
Answer: A) The SAE must be reported to the IRB/IEC and the sponsor immediately.
What is the primary purpose of the Declaration of Helsinki?
- A) To provide guidelines for the publication of medical research
- B) To offer ethical principles for medical research involving human subjects
- C) To regulate the compensation of medical research subjects
- D) To mandate legal requirements for international medical research
Answer: B) To offer ethical principles for medical research involving human subjects
According to the Declaration of Helsinki, who has the primary duty to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects?
- A) The research sponsors
- B) The research subjects
- C) The physicians or other healthcare professionals involved in the research
- D) The regulatory authorities
**Answer: C) The physicians or other healthcare professionals involved in the research*
Which of the following statements is true about medical research involving human subjects?
- A) It can only be conducted if it involves no risks or burdens to the research subjects.
- B) It must always prioritize the rights and interests of individual research subjects over the goal of generating new knowledge.
- C) It is justified if the potential benefits to other individuals or groups affected by the condition under investigation outweigh the risks and burdens to the research subjects.
- D) It should not include any vulnerable groups.
Answer: B) It must always prioritize the rights and interests of individual research subjects over the goal of generating new knowledge.
What is required before a research study involving human subjects begins, according to the Declaration of Helsinki?
- A) Approval by a competent and appropriately qualified physician
- B) Funding from an ethical and reputable sponsor
- C) Submission and approval of the research protocol by a research ethics committee
- D) Consent from the local community where the research will be conducted
Answer: C) Submission and approval of the research protocol by a research ethics committee
Question 5
In the context of the Declaration of Helsinki, what should be done when seeking informed consent from a potential research subject who is in a dependent relationship with the physician?
- A) Informed consent must be obtained from the potential subject without any outside involvement.
- B) The research can proceed without informed consent if it is for the subject’s benefit.
- C) An appropriately qualified individual who is completely independent of this relationship should seek the informed consent.
- D) Informed consent should not be sought in this scenario.
Answer: C) An appropriately qualified individual who is completely independent of this relationship should seek the informed consent.
Which of the following is NOT a requirement for medical research involving human subjects as outlined in the Declaration of Helsinki?
- A) The research must conform to generally accepted scientific principles.
- B) The research must be based on thorough knowledge of the scientific literature.
- C) The research must have the potential to benefit the research subjects directly.
- D) The research protocol must describe appropriate arrangements for post-trial provisions.
Answer: C) The research must have the potential to benefit the research subjects directly.
Question 7
How should vulnerable groups and individuals be treated in medical research, according to the Declaration of Helsinki?
- A) They should not be included in medical research.
- B) They should be included only if the research cannot be carried out in a non-vulnerable group and is responsive to the health needs or priorities of the vulnerable group.
- C) They should be included only if they provide explicit written consent.
- D) They should be given the same protections as other groups but with no special considerations.
Answer: B) They should be included only if the research cannot be carried out in a non-vulnerable group and is responsive to the health needs or priorities of the vulnerable group.
What should be included in a research protocol, as per the Declaration of Helsinki?
- A) Only the scientific objectives of the research
- B) Ethical considerations, funding sources, potential conflicts of interest, and provisions for treating or compensating subjects who are harmed
- C) A list of all research subjects involved in the study
- D) A summary of the anticipated results
Answer: B) Ethical considerations, funding sources, potential conflicts of interest, and provisions for treating or compensating subjects who are harmed
Under what condition is the use of a placebo acceptable in medical research, according to the Declaration of Helsinki?
- A) When the research subject agrees to it
- B) When there is no proven intervention available
- C) When it is less expensive than the proven intervention
- D) When it is required by the research ethics committee
Answer: B) When there is no proven intervention available
What must be done to ensure the privacy and confidentiality of research subjects, as stated in the Declaration of Helsinki?
- A) All data must be anonymized before publication.
- B) Research subjects must sign a confidentiality agreement.
- C) Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.
- D) Personal information of subjects must be stored in a secure database.
Answer: C) Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.
Question 1: What is the primary purpose of the ICH-GCP guidelines?
A. To ensure that clinical trials are conducted ethically and scientifically
B. To increase the profitability of pharmaceutical companies
C. To reduce the cost of drug development
D. To limit the number of clinical trials conducted globally
A. To ensure that clinical trials are conducted ethically and scientifically
Question 2: According to ICH-GCP, what must be obtained from every clinical trial participant before they can participate in a trial?
A. Financial contribution
B. Informed consent
C. Medical records
D. Insurance details
B. Informed consent
Question 3: What is one of the key responsibilities of a Principal Investigator (PI) according to ICH-GCP?
A. To monitor data management systems
B. To delegate all trial-related duties to sub-investigators
C. To ensure the trial is conducted in compliance with the protocol
D. To fund the trial
C. To ensure the trial is conducted in compliance with the protocol
Question 4: Which document must an investigator sign to indicate they have read and understood the trial protocol?
A. Case Report Form (CRF)
B. Investigator’s Brochure (IB)
C. Protocol signature page
D. Informed Consent Form (ICF)
C. Protocol signature page
Question 5: What is a sponsor’s responsibility in relation to the investigational product (IP)?
A. To manufacture the IP according to Good Manufacturing Practice (GMP)
B. To administer the IP to trial subjects
C. To determine the market price of the IP
D. To destroy all unused IP after the trial
A. To manufacture the IP according to Good Manufacturing Practice (GMP)
Question 6: Who is responsible for selecting investigators for a clinical trial?
A. The clinical trial monitor
B. The sponsor
C. The regulatory authority
D. The trial subjects
B. The sponsor
Question 7: What is the primary goal of monitoring in a clinical trial?
A. To ensure data entry is fast
B. To ensure compliance with the protocol and GCP
C. To reduce the number of trial participants
D. To increase the trial budget
B. To ensure compliance with the protocol and GCP
Question 8: What is the difference between monitoring and auditing in clinical trials?
A. Monitoring is conducted by the regulatory authority; auditing is conducted by the sponsor
B. Monitoring is a continuous process; auditing is a systematic and independent examination
C. Monitoring is for financial purposes; auditing is for ethical purposes
D. Monitoring occurs post-trial; auditing occurs pre-trial
B. Monitoring is a continuous process; auditing is a systematic and independent examination
Question 9: According to ICH guidelines, what must be done if a Serious Adverse Event (SAE) occurs during a clinical trial?
A. Report it to the sponsor immediately
B. Ignore it if it is not related to the investigational product
C. Wait until the end of the trial to report it
D. Report it only if the participant withdraws from the trial
A. Report it to the sponsor immediately
Question 10: What is the definition of an adverse event (AE) according to ICH-GCP?
A. Any untoward medical occurrence in a participant administered a pharmaceutical product
B. Any positive health outcome in a participant administered a placebo
C. Any pre-existing condition of the participant
D. Any protocol deviation
A. Any untoward medical occurrence in a participant administered a pharmaceutical product
Question 11: What essential information must be provided to participants during the informed consent process?
A. The financial status of the sponsor
B. The detailed scientific background of the investigators
C. The purpose of the trial, procedures, risks, and benefits
D. The names of other participants
C. The purpose of the trial, procedures, risks, and benefits
Question 12: According to ICH guidelines, who is responsible for ensuring that informed consent is obtained before a participant is enrolled in a clinical trial?
A. The trial monitor
B. The sponsor
C. The investigator
D. The regulatory authority
C. The investigator
Question 13: Which document outlines the detailed plan for a clinical trial?
A. The Investigator’s Brochure (IB)
B. The Protocol
C. The Informed Consent Form (ICF)
D. The Case Report Form (CRF)
B. The Protocol
Question 14: For how long must essential documents be retained after the completion of a clinical trial according to ICH-GCP guidelines?
A. 1 year
B. 2 years
C. Until the regulatory approval is obtained
D. As specified by the regulatory requirements and/or sponsor
D. As specified by the regulatory requirements and/or sponsor
Question 15: According to ICH-GCP, who has the ultimate authority to approve a clinical trial protocol?
A. The sponsor
B. The Principal Investigator
C. The Institutional Review Board/Ethics Committee (IRB/EC)
D. The trial monitor
C. The Institutional Review Board/Ethics Committee (IRB/EC)
Question 16: What principle must guide the conduct of clinical trials according to ICH-GCP?
A. Maximizing profit for sponsors
B. Ensuring participant recruitment targets are met
C. Protecting the rights, safety, and well-being of trial participants
D. Guaranteeing rapid regulatory approval
C. Protecting the rights, safety, and well-being of trial participants
Question 17: What is the primary purpose of quality assurance in clinical trials?
A. To speed up the data collection process
B. To ensure that trials are conducted and data are generated, documented, and reported in compliance with GCP
C. To reduce the cost of the trial
D. To increase the number of participants
B. To ensure that trials are conducted and data are generated, documented, and reported in compliance with GCP
Question 18: What is the role of quality control in clinical trials?
A. To identify and address issues in real-time to ensure data integrity
B. To design the clinical trial protocol
C. To manage the trial budget
D. To recruit trial participants
A. To identify and address issues in real-time to ensure data integrity
Section 10: Trial Design and Protocol Development
Question 19: What is a key component of a clinical trial protocol?
A. The financial status of the sponsor
B. The specific objectives and purpose of the trial
C. The marketing strategy for the investigational product
D. The biographies of all study staff
B. The specific objectives and purpose of the trial
Question 20: Which phase of clinical trial is primarily concerned with assessing the safety and dosage of a new drug?
A. Phase I
B. Phase II
C. Phase III
D. Phase IV
A. Phase I
Question 21: Which regulatory body is responsible for approving new drugs in the United States?
A. EMA (European Medicines Agency)
B. FDA (Food and Drug Administration)
C. MHRA (Medicines and Healthcare products Regulatory Agency)
D. PMDA (Pharmaceuticals and Medical Devices Agency)
B. FDA (Food and Drug Administration)
Question 22: What does the term “ICH E6” refer to?
A. A type of investigational product
B. A specific guideline for Good Clinical Practice (GCP)
C. A phase of clinical trials
D. A regulatory agency
B. A specific guideline for Good Clinical Practice (GCP)
Question 23: Who is responsible for the proper handling and storage of the investigational product at the trial site?
A. The sponsor
B. The trial participants
C. The Principal Investigator
D. The regulatory authority
C. The Principal Investigator
Question 24: According to ICH-GCP, what must be documented regarding the investigational product?
A. The marketing plan
B. The source, date of receipt, and dispensing of each product
C. The financial cost
D. The packaging design
B. The source, date of receipt, and dispensing of each product
Question 25: What is the primary purpose of a Case Report Form (CRF)?
A. To document protocol deviations
B. To collect data required by the trial protocol
C. To track the financial status of the trial
D. To communicate with regulatory authorities
B. To collect data required by the trial protocol
Question 26: Who is responsible for ensuring the accuracy and completeness of data recorded on the CRFs?
A. The sponsor
B. The data management team
C. The Principal Investigator
D. The trial participants
C. The Principal Investigator
Question 27: What is an unexpected adverse drug reaction according to ICH guidelines?
A. An adverse reaction that is more severe than anticipated
B. An adverse reaction that occurs at a lower frequency than expected
C. An adverse reaction not consistent with the applicable product information
D. An adverse reaction that occurs in more than 10% of participants
C. An adverse reaction not consistent with the applicable product information
Question 28: How soon must a serious adverse event (SAE) be reported to the sponsor?
A. Within 24 hours
B. Within 72 hours
C. Within one week
D. By the end of the trial
A. Within 24 hours
Question 29: According to ICH-GCP, what is a fundamental ethical consideration in clinical trials?
A. Maximizing profit for the sponsor
B. Protecting the confidentiality of participant data
C. Ensuring rapid trial completion
D. Recruiting as many participants as possible
B. Protecting the confidentiality of participant data
Question 30: What must be included in the informed consent form (ICF) according to ICH-GCP?
A. A detailed description of the investigational product
B. A summary of previous clinical trials
C. The potential risks and benefits of participation
D. The sponsor’s contact details
C. The potential risks and benefits of participation
Question 31: What is the purpose of the Investigator’s Brochure (IB)?
A. To provide clinical and non-clinical data on the investigational product
B. To outline the trial budget
C. To describe the trial recruitment strategy
D. To detail the marketing plan for the investigational product
A. To provide clinical and non-clinical data on the investigational product
Question 32: Who is primarily responsible for updating the Investigator’s Brochure?
A. The Principal Investigator
B. The Ethics Committee
C. The sponsor
D. The trial monitor
C. The sponsor
Question 33: What is one of the primary functions of an IRB/EC?
A. To develop the trial protocol
B. To review and approve the trial protocol to ensure participant safety and rights are protected
C. To conduct the clinical trial
D. To fund the clinical trial
B. To review and approve the trial protocol to ensure participant safety and rights are protected
Question 34: How often must an ongoing clinical trial be reviewed by the IRB/EC?
A. Only at the start of the trial
B. Annually or more frequently if specified by the IRB/EC
C. At the end of the trial
D. Every five years
B. Annually or more frequently if specified by the IRB/EC
Question 35: According to ICH-GCP, what is a protocol deviation?
A. A necessary change to improve trial results
B. A documented change from the approved protocol
C. A planned change in the trial design
D. An unapproved change in the trial budget
B. A documented change from the approved protocol
Question 36: Who is responsible for ensuring that the clinical trial is conducted in compliance with the approved protocol?
A. The trial monitor
B. The regulatory authority
C. The Principal Investigator
D. The trial participants
C. The Principal Investigator
Question 37: What must the sponsor provide to the investigator before the trial begins?
A. The final clinical trial report
B. The Investigator’s Brochure (IB)
C. A list of potential trial participants
D. A detailed marketing plan
B. The Investigator’s Brochure (IB)
Question 38: How should serious breaches of the trial protocol be handled according to ICH-GCP?
A. They should be documented and reported to the sponsor and regulatory authorities
B. They should be ignored if they do not affect the primary outcome
C. They should be reported only at the end of the trial
D. They should be corrected without documentation
A. They should be documented and reported to the sponsor and regulatory authorities
Question 39: What is the purpose of the clinical trial report?
A. To summarize the financial aspects of the trial
B. To provide a comprehensive and accurate description of the trial and its results
C. To document protocol deviations
D. To communicate with trial participants
B. To provide a comprehensive and accurate description of the trial and its results
Question 40: Who is responsible for preparing the final clinical trial report?
A. The Principal Investigator
B. The sponsor
C. The trial monitor
D. The regulatory authority
B. The sponsor
Question 41: In a multi-center trial, who is responsible for ensuring all sites conduct the trial in accordance with the protocol?
A. The sponsor
B. The Principal Investigator at each site
C. The regulatory authority
D. The trial monitor
A. The sponsor
Question 42: What is a Coordinating Investigator’s role in a multi-center trial?
A. To oversee the overall conduct of the trial at all participating sites
B. To handle financial matters for all sites
C. To recruit participants at all sites
D. To approve the trial protocol
A. To oversee the overall conduct of the trial at all participating sites
Question 43: According to ICH-GCP, who is responsible for maintaining records of the investigational product’s receipt, use, and disposal?
A. The trial participants
B. The sponsor
C. The investigator
D. The regulatory authority
C. The investigator
Question 44: What should be done with unused investigational products at the end of the trial?
A. Return them to the sponsor or dispose of them according to regulatory requirements
B. Distribute them to trial participants
C. Store them indefinitely at the trial site
D. Sell them to recover costs
A. Return them to the sponsor or dispose of them according to regulatory requirements
Question 45: What is the main purpose of monitoring visits in clinical trials?
A. To ensure participant recruitment
B. To verify that the rights and well-being of participants are protected
C. To increase the trial budget
D. To finalize the clinical trial report
B. To verify that the rights and well-being of participants are protected
Question 46: Who typically conducts monitoring visits?
A. The trial participants
B. The sponsor’s designated monitors
C. The regulatory authority
D. The Principal Investigator
B. The sponsor’s designated monitors
Question 47: What is the purpose of data management in clinical trials?
A. To ensure that trial data are accurate, complete, and consistent
B. To recruit trial participants
C. To market the investigational product
D. To manage the trial budget
A. To ensure that trial data are accurate, complete, and consistent
Question 48: What is a statistical analysis plan (SAP)?
A. A document that outlines the financial aspects of the trial
B. A pre-defined plan for the statistical analysis of trial data
C. A marketing strategy for the investigational product
D. A summary of protocol deviations
B. A pre-defined plan for the statistical analysis of trial data
Question 49: What qualifications must an investigator have according to ICH-GCP?
A. Appropriate education, training, and experience to conduct the trial
B. Financial resources to fund the trial
C. Personal connections with the sponsor
D. Marketing experience
A. Appropriate education, training, and experience to conduct the trial
Question 50: What document must an investigator sign to confirm their commitment to comply with GCP and the trial protocol?
A. The Informed Consent Form (ICF)
B. The Investigator Agreement
C. The Case Report Form (CRF)
D. The trial budget agreement
B. The Investigator Agreement
Question 51: What are source documents in the context of clinical trials?
A. Documents that contain original data and records
B. Marketing materials for the investigational product
C. Financial reports of the trial
D. Protocol deviation logs
A. Documents that contain original data and records
Question 52: Why are source documents important in clinical trials?
A. They provide a basis for monitoring and verification of trial data
B. They summarize the financial status of the trial
C. They are used for marketing purposes
D. They list potential trial participants
A. They provide a basis for monitoring and verification of trial data
Question 53: What must be done at the close of a clinical trial?
A. Return or dispose of the investigational product
B. Destroy all trial-related documents
C. Recruit more participants
D. Modify the trial protocol
A. Return or dispose of the investigational product
Question 54: What is the purpose of a close-out visit?
A. To verify that all trial-related activities are completed and all records are in order
B. To finalize the marketing strategy for the investigational product
C. To recruit additional participants
D. To conduct the statistical analysis
A. To verify that all trial-related activities are completed and all records are in order
Question 55: What is a key consideration in recruiting participants for a clinical trial?
A. Ensuring participants understand the trial and provide informed consent
B. Maximizing the number of participants regardless of eligibility criteria
C. Recruiting participants only from specific geographic locations
D. Offering financial incentives for participation
A. Ensuring participants understand the trial and provide informed consent
Question 56: What strategies can help improve participant retention in clinical trials?
A. Providing clear and frequent communication with participants
B. Increasing the trial budget
C. Reducing the number of study visits
D. Offering higher financial compensation
A. Providing clear and frequent communication with participants
Question 57: What is the purpose of blinding in a clinical trial?
A. To prevent bias in the assessment of outcomes
B. To increase the trial budget
C. To recruit more participants
D. To expedite regulatory approval
A. To prevent bias in the assessment of outcomes
Question 58: How does randomization contribute to the integrity of a clinical trial?
A. It ensures that trial participants are recruited evenly
B. It minimizes selection bias and confounding variables
C. It increases the profitability of the trial
D. It simplifies the trial design
B. It minimizes selection bias and confounding variables
Question 59: What is the purpose of an interim analysis in a clinical trial?
A. To make adjustments to the trial budget
B. To evaluate data at intervals before the trial is completed
C. To recruit more participants
D. To finalize the trial report
B. To evaluate data at intervals before the trial is completed
Question 60: What role does a Data Safety Monitoring Board (DSMB) play in clinical trials?
A. To ensure participant safety and data integrity through periodic review
B. To manage the financial aspects of the trial
C. To conduct the statistical analysis
D. To recruit trial participants
A. To ensure participant safety and data integrity through periodic review
Question 61: How should protocol amendments be handled according to ICH-GCP?
A. They must be approved by the IRB/EC before implementation
B. They can be implemented without any approval
C. They should be documented but not reported
D. They must be approved by trial participants
A. They must be approved by the IRB/EC before implementation
Question 62: What is a protocol deviation?
A. Any change from the protocol not approved by the IRB/EC
B. A planned change in the trial design
C. An increase in the trial budget
D. A minor administrative change
A. Any change from the protocol not approved by the IRB/EC
Question 63: What is the Trial Master File (TMF)?
A. A comprehensive collection of all essential documents for a clinical trial
B. A financial report of the trial
C. A list of trial participants
D. A summary of protocol deviations
A. A comprehensive collection of all essential documents for a clinical trial
Question 64: Who is responsible for maintaining the Trial Master File?
A. The trial monitor
B. The sponsor
C. The Principal Investigator
D. The IRB/EC
B. The sponsor
Question 65: What is the purpose of investigator meetings in clinical trials?
A. To train investigators on the trial protocol and GCP requirements
B. To finalize the trial budget
C. To recruit trial participants
D. To conduct the statistical analysis
A. To train investigators on the trial protocol and GCP requirements
Question 66: Why is ongoing training important for clinical trial investigators?
A. To ensure they stay current with GCP and protocol requirements
B. To manage the financial aspects of the trial
C. To recruit more participants
D. To expedite regulatory approval
A. To ensure they stay current with GCP and protocol requirements
Question 67: What should be included in a clinical trial agreement between the sponsor and the investigator?
A. Detailed financial compensation and responsibilities
B. The marketing strategy for the investigational product
C. The personal contact information of trial participants
D. A summary of previous clinical trials
A. Detailed financial compensation and responsibilities
Question 68: Who is responsible for negotiating clinical trial agreements?
A. The trial participants
B. The sponsor and the investigator/institution
C. The IRB/EC
D. The regulatory authority
B. The sponsor and the investigator/institution
Question 69: What is an IND application?
A. A request for permission to conduct a clinical trial with an investigational drug
B. A financial plan for the clinical trial
C. A marketing strategy for the investigational product
D. A recruitment plan for trial participants
A. A request for permission to conduct a clinical trial with an investigational drug
Question 70: Who submits the IND application to the regulatory authority?
A. The Principal Investigator
B. The sponsor
C. The trial monitor
D. The IRB/EC
B. The sponsor
Question 71: What are Good Documentation Practices (GDP)?
A. Standards for ensuring accuracy, consistency, and integrity of data and documents
B. Guidelines for increasing trial recruitment
C. Practices for managing the trial budget
D. Strategies for marketing the investigational product
A. Standards for ensuring accuracy, consistency, and integrity of data and documents
Question 72: Why is adherence to GDP important in clinical trials?
A. To ensure data are reliable and regulatory requirements are met
B. To expedite trial completion
C. To reduce trial costs
D. To recruit more participants
A. To ensure data are reliable and regulatory requirements are met
Question 73: What is an essential component of a clinical trial budget?
A. Costs related to participant recruitment and retention
B. The marketing plan for the investigational product
C. The final clinical trial report
D. The personal biographies of the investigators
A. Costs related to participant recruitment and retention
Question 74: Who is responsible for managing the clinical trial budget?
A. The trial participants
B. The sponsor
C. The regulatory authority
D. The IRB/EC
B. The sponsor
Question 75: What factors should be considered when selecting a trial site?
A. The site’s experience with similar trials and its patient population
B. The site’s proximity to the sponsor’s headquarters
C. The site’s marketing capabilities
D. The site’s financial status
A. The site’s experience with similar trials and its patient population
Question 76: Who is responsible for selecting trial sites?
A. The trial participants
B. The sponsor
C. The regulatory authority
D. The IRB/EC
B. The sponsor
Question 77: How long must clinical trial records be retained after the trial is completed?
A. As specified by regulatory requirements and/or the sponsor
B. For one year
C. Until the trial report is published
D. Until all participants are contacted
A. As specified by regulatory requirements and/or the sponsor
Question 78: What is the purpose of record retention in clinical trials?
A. To allow for verification and review of data and compliance with regulatory requirements
B. To recruit more participants
C. To manage the trial budget
D. To finalize the marketing strategy
A. To allow for verification and review of data and compliance with regulatory requirements
Question 79: What is required for the follow-up of adverse events (AEs) in clinical trials?
A. Ongoing monitoring and documentation until resolution or stabilization
B. Immediate trial termination
C. Financial compensation to participants
D. Modification of the trial protocol
A. Ongoing monitoring and documentation until resolution or stabilization
Question 80: Who is responsible for the follow-up and reporting of adverse events?
A. The trial monitor
B. The Principal Investigator
C. The regulatory authority
D. The trial participants
B. The Principal Investigator
Question 1: When was the World Medical Association Declaration of Helsinki first adopted?
A. 1964
B. 1975
C. 1983
D. 2000
A. 1964
Question 2: Which principle does the Declaration of Helsinki primarily address?
A. Financial aspects of clinical trials
B. Ethical principles for medical research involving human subjects
C. Legal requirements for drug approval
D. Marketing strategies for pharmaceuticals
B. Ethical principles for medical research involving human subjects
Question 3: Who does the WMA encourage to adopt the principles of the Declaration of Helsinki?
A. Only physicians
B. Only nurses
C. All individuals involved in medical research involving human subjects
D. Only government regulators
C. All individuals involved in medical research involving human subjects
Question 4: According to the Declaration of Geneva, what is the physician’s primary consideration?
A. The profitability of the research
B. The health of the patient
C. The efficiency of the treatment
D. The regulatory compliance
B. The health of the patient
Question 5: What is the duty of the physician in medical research according to the Declaration of Helsinki?
A. To safeguard the financial interests of the sponsor
B. To promote and safeguard the health, well-being, and rights of patients
C. To maximize the efficiency of the research
D. To ensure regulatory compliance
B. To promote and safeguard the health, well-being, and rights of patients
Question 6: What must medical progress ultimately include, according to the Declaration of Helsinki?
A. Studies involving only animals
B. Studies involving human subjects
C. Studies without any risk
D. Studies focusing solely on financial gains
B. Studies involving human subjects
Question 7: What must medical research involving human subjects be preceded by?
A. A detailed financial plan
B. Careful assessment of predictable risks and burdens
C. Approval from the pharmaceutical company
D. Public opinion surveys
B. Careful assessment of predictable risks and burdens
Question 8: What should be continuously monitored, assessed, and documented by the researcher in medical research?
A. Financial expenditures
B. Risks and burdens to the research subjects
C. Public relations impact
D. Legal compliance
B. Risks and burdens to the research subjects
Question 9: When should physicians assess whether to continue, modify, or stop a research study?
A. When the financial goals are not met
B. When the risks are found to outweigh the potential benefits
C. When the public opinion is negative
D. When the regulatory bodies demand it
B. When the risks are found to outweigh the potential benefits
Question 10: Under what condition is medical research with a vulnerable group justified?
A. If it is financially profitable
B. If it is responsive to the health needs or priorities of this group
C. If it has no risks involved
D. If it is supported by the majority public opinion
B. If it is responsive to the health needs or priorities of this group
Question 11: What should vulnerable groups and individuals receive in medical research?
A. Special consideration and protection
B. Financial compensation only
C. No additional protection
D. Preferential treatment
A. Special consideration and protection
Question 12: What must medical research involving human subjects conform to?
A. Financial guidelines
B. Generally accepted scientific principles
C. Political mandates
D. Media guidelines
B. Generally accepted scientific principles
Question 13: What should the research protocol include?
A. Statement of ethical considerations
B. Marketing strategies
C. Political opinions
D. Media endorsements
A. Statement of ethical considerations
Question 14: In clinical trials, what must the protocol describe?
A. Financial benefits for the sponsors
B. Appropriate arrangements for post-trial provisions
C. Media coverage plans
D. Political advantages
B. Appropriate arrangements for post-trial provisions
Question 15: What must the research protocol be submitted to before the study begins?
A. A financial committee
B. A research ethics committee
C. A political committee
D. A media committee
B. A research ethics committee
Question 16: What right must the research ethics committee have?
A. To approve financial transactions
B. To monitor ongoing studies
C. To conduct media interviews
D. To manage political campaigns
B. To monitor ongoing studies
Question 17: What must researchers submit to the research ethics committee after the end of the study?
A. A financial report
B. A final report containing a summary of the study’s findings and conclusions
C. A media report
D. A political report
B. A final report containing a summary of the study’s findings and conclusions
Question 18: What must be taken to protect the privacy of research subjects and the confidentiality of their personal information?
A. Financial measures
B. Legal measures
C. Every precaution
D. Media measures
C. Every precaution
Question 19: Participation in medical research must be what?
A. Mandatory
B. Voluntary
C. Financially compensated
D. Politically endorsed
B. Voluntary
Question 20: What must be done if a potential research subject is incapable of giving informed consent?
A. The research must be stopped
B. Informed consent must be sought from the legally authorized representative
C. The subject must be excluded from the research
D. Financial compensation must be provided
B. Informed consent must be sought from the legally authorized representative
Question 21: What should the physician do when seeking informed consent from a subject who may be in a dependent relationship with the physician?
A. Ignore the relationship
B. Seek consent from an independent, appropriately qualified individual
C. Proceed without consent
D. Obtain financial compensation
B. Seek consent from an independent, appropriately qualified individual
Question 22: When must consent be obtained from the subject or a legally authorized representative in cases where subjects are physically or mentally incapable of giving consent?
A. Before the study begins
B. As soon as possible if the research cannot be delayed
C. After the study ends
D. When financially feasible
B. As soon as possible if the research cannot be delayed
Question 23: Under what circumstances is the use of placebo acceptable?
A. When there is a financial incentive
B. Where no proven intervention exists
C. When it is politically endorsed
D. When the media approves
B. Where no proven intervention exists
Question 24: What should be made for all participants who still need an intervention identified as beneficial in the trial?
A. Financial compensation
B. Provisions for post-trial access
C. Media coverage
D. Political support
B. Provisions for post-trial access
Question 25: Where must every research study involving human subjects be registered?
A. In a private database
B. In a publicly accessible database
C. In a financial registry
D. In a political document
B. In a publicly accessible database
Question 1: What is the primary purpose of pediatric extrapolation according to the ICH E11A guideline?
A. To reduce the cost of clinical trials
B. To apply adult data to pediatric populations to predict drug efficacy and safety
C. To eliminate the need for pediatric clinical trials
D. To streamline the regulatory approval process
B. To apply adult data to pediatric populations to predict drug efficacy and safety
Question 2: Which of the following is a key consideration in pediatric extrapolation?
A. The financial cost of clinical trials
B. The pharmacokinetic and pharmacodynamic differences between adults and children
C. The marketing strategy for pediatric drugs
D. The regulatory environment in the country of study
B. The pharmacokinetic and pharmacodynamic differences between adults and children
Question 3: What is the first step in the pediatric extrapolation process?
A. Conducting a literature review
B. Defining the research question and the target pediatric population
C. Submitting the protocol to the regulatory authority
D. Conducting adult clinical trials
B. Defining the research question and the target pediatric population
Question 4: What role does modeling and simulation play in pediatric extrapolation?
A. They replace the need for any clinical trials
B. They help predict drug behavior in pediatric populations
C. They ensure financial efficiency
D. They streamline the marketing process
B. They help predict drug behavior in pediatric populations
Question 5: Which type of data is essential for informing pediatric extrapolation?
A. Market analysis data
B. Pharmacokinetic, pharmacodynamic, and clinical efficacy and safety data
C. Financial data
D. Social media data
B. Pharmacokinetic, pharmacodynamic, and clinical efficacy and safety data
Question 6: What is a major challenge in pediatric extrapolation?
A. Lack of financial resources
B. Differences in disease progression and drug response between adults and children
C. Regulatory approval delays
D. Public perception of pediatric drug testing
B. Differences in disease progression and drug response between adults and children
Question 7: Which of the following data is least likely to be directly extrapolated from adults to children?
A. Pharmacokinetic data
B. Safety data
C. Market research data
D. Efficacy data
C. Market research data
Question 8: Why is it important to understand the disease pathophysiology in both adult and pediatric populations during extrapolation?
A. To align marketing strategies
B. To ensure the extrapolated data is relevant and applicable
C. To reduce the cost of clinical trials
D. To expedite the regulatory approval process
B. To ensure the extrapolated data is relevant and applicable
Question 9: What type of study design might be used when direct extrapolation is not possible?
A. Observational study
B. Randomized controlled trial
C. Single-arm trial
D. Simulation study
B. Randomized controlled trial
Question 10: How can adult pharmacokinetic data be used in pediatric extrapolation?
A. By directly applying adult dosages to children
B. By scaling adult pharmacokinetic parameters to predict pediatric doses
C. By eliminating the need for pediatric clinical trials
D. By reducing the regulatory requirements
B. By scaling adult pharmacokinetic parameters to predict pediatric doses
Question 11: What is an important consideration when extrapolating safety data from adults to children?
A. The financial cost of safety studies
B. The potential for different adverse effects in children
C. The marketing potential for pediatric drugs
D. The ease of regulatory approval
B. The potential for different adverse effects in children
Question 12: According to ICH E11A, who should be involved in the pediatric extrapolation process?
A. Only pediatricians
B. A multidisciplinary team including pharmacologists, pediatricians, and regulatory experts
C. Only regulatory authorities
D. Only clinical trial coordinators
B. A multidisciplinary team including pharmacologists, pediatricians, and regulatory experts
Question 13: When should pediatric extrapolation plans be discussed with regulatory authorities?
A. After the adult clinical trials are completed
B. As early as possible during drug development
C. Only during the final submission for approval
D. Only if problems arise during clinical trials
B. As early as possible during drug development
Question 14: What is the role of regulatory authorities in pediatric extrapolation?
A. To design the extrapolation studies
B. To provide guidelines and evaluate the extrapolation plans
C. To fund the extrapolation studies
D. To market the pediatric drugs
B. To provide guidelines and evaluate the extrapolation plans
Question 15: Which of the following is a potential outcome of successful pediatric extrapolation?
A. Faster time to market for pediatric drugs
B. Higher costs of clinical trials
C. Increased regulatory hurdles
D. Reduced market potential for pediatric drugs
A. Faster time to market for pediatric drugs
Question 16: What is a critical factor for the success of pediatric extrapolation?
A. The financial backing of the pharmaceutical company
B. The relevance and quality of the adult data
C. The marketing strategy for the pediatric population
D. The public perception of pediatric drug testing
B. The relevance and quality of the adult data
Question 17:** What is a potential benefit of pediatric extrapolation for drug development?
A. Reduced need for extensive pediatric trials
B. Increased financial burden
C. Slower regulatory approval
D. Reduced effectiveness of pediatric drugs
A. Reduced need for extensive pediatric trials
Question 18: What ethical principle must be considered in pediatric extrapolation?
A. Maximizing profit
B. Protecting the rights and safety of pediatric participants
C. Speeding up the drug approval process
D. Reducing regulatory oversight
B. Protecting the rights and safety of pediatric participants
Question 19: Why is it important to minimize the number of pediatric clinical trials?
A. To reduce costs
B. To protect pediatric participants from unnecessary risks
C. To expedite the regulatory process
D. To maximize market potential
B. To protect pediatric participants from unnecessary risks
Question 20: How can informed consent be ethically managed in pediatric extrapolation studies?
A. By involving only parents in the consent process
B. By ensuring both parents and pediatric participants (when appropriate) understand the study
C. By simplifying the consent forms to one page
D. By avoiding detailed discussions about potential risks
B. By ensuring both parents and pediatric participants (when appropriate) understand the study
Question 21: What statistical method is often used in pediatric extrapolation?
A. Regression analysis
B. Meta-analysis
C. Bayesian modeling
D. Chi-square test
C. Bayesian modeling
Question 22: How can variability between adult and pediatric populations be accounted for in statistical models?
A. By ignoring it
B. By using sensitivity analyses
C. By reducing sample sizes
D. By increasing the study duration
B. By using sensitivity analyses
Question 23: What clinical consideration is important in pediatric extrapolation?
A. The cost of clinical trials
B. The disease progression and drug response differences between adults and children
C. The marketing strategy
D. The regulatory environment
B. The disease progression and drug response differences between adults and children
Question 24: Why is it necessary to validate extrapolation assumptions with clinical data?
A. To increase market share
B. To ensure the accuracy and relevance of the extrapolated data
C. To reduce clinical trial costs
D. To streamline regulatory approval
B. To ensure the accuracy and relevance of the extrapolated data
Question 25: When might direct extrapolation from adults to children not be appropriate?
A. When the drug’s mechanism of action is the same in both populations
B. When there are significant differences in disease progression between adults and children
C. When the marketing potential is high
D. When regulatory guidelines are clear
B. When there are significant differences in disease progression between adults and children
Question 26: What is a key factor in determining the appropriate pediatric population for extrapolation?
A. Financial considerations
B. Disease similarity between adult and pediatric populations
C. Marketing potential
D. Regulatory environment
B. Disease similarity between adult and pediatric populations
Question 27: Which age group may require specific consideration due to rapid developmental changes?
A. Adolescents
B. Infants and toddlers
C. Middle-aged adults
D. Elderly
B. Infants and toddlers`\
Question 28: Why is it important to continuously monitor safety in pediatric extrapolation studies?
A. To increase market potential
B. To protect pediatric participants from potential adverse effects
C. To expedite the regulatory process
D. To reduce costs
B. To protect pediatric participants from potential adverse effects
Question 29: How should efficacy data be handled in pediatric extrapolation?
A. By assuming it is the same as in adults
B. By carefully evaluating and validating the extrapolated data
C. By focusing only on financial aspects
D. By ignoring it
B. By carefully evaluating and validating the extrapolated data
Question 30: What is a common challenge in pediatric extrapolation?
A. Aligning marketing strategies
B. Accounting for developmental differences between adults and children
C. Reducing regulatory oversight
D. Increasing trial costs
B. Accounting for developmental differences between adults and children
Question 1:
Which of the following best describes “clinical equipoise”?
A) The balance between potential benefits and risks for an individual participant
B) The ethical principle that requires a genuine uncertainty within the expert medical community about the comparative therapeutic merits of each arm in a clinical trial
C) The obligation to minimize risks and maximize benefits for clinical trial participants
D) The ethical dilemma faced by researchers when deciding whether to continue a trial after adverse events
B) The ethical principle that requires a genuine uncertainty within the expert medical community about the comparative therapeutic merits of each arm in a clinical trial
