CCRC Exam (Latest 2024/ 2025 Update) Practice Questions and Verified Answers| 100% Correct| Grade A
CCRC Exam (Latest 2024/ 2025 Update)
Practice Questions and Verified Answers|
100% Correct| Grade A
Q: What does CDER stand for?
Answer:
Center for Drug Evaluation and Research
Q: What does CBER stand for?
Answer:
Center for Biologics Evaluation and Research
Q: What is the central goal of the harmonization effort?
Answer:
To identify and then reduce differences in technical requirements for drug development among
regulatory agencies
Q: What organization’s goal is to identify and then reduce differences in technical requirements
for drug development among regulatory agencies?
Answer:
harmonization effort
Q: Why was the ICH organized?
Answer:
to provide an opportunity for development of tripartite harmonization initiatives based on input
from both regulatory and industry representatives
Q: What organization was created to provide an opportunity for development of tripartite
harmonization initiatives based on input from both regulatory and industry representatives
Answer:
ICH (International Conference on Harmonization)
Q: What does ICH stand for?
Answer:
International Conference on Harmonization
Q: The ICH seeks to harmonize requirements from which three regions?
Answer:
European Union, Japan, United States
Q: The ICH is concerned with harmonization of _ with the European Union, Japan, and the United states Answer: technical requirements for registration of pharmaceutical products Q: The ICH Secretariat coordinates documentation.
Answer:
ICH
Q: What organization is the ICH Secretariat affiliated?
Answer:
The international Federation of Pharmaceutical Manufacturers Association (IFPMA)
Q: What does IFPMA stand for?
Answer:
International Federation of Pharmaceutical Manufacturers Association
Q: The IFPMA is associated with which part of ICH?
Answer:
ICH Secretariat
Q: What are the three industry association sponsors of ICH?
Answer:
European Federation of Pharmaceutical Industries Association
Japanese Pharmaceutical Manufacturers Association
Pharmaceutical Research and Manufacturers of America
Q: What is the European industry association sponsor of ICH?
Answer:
European Federation of Pharmaceutical Industries Association
Q: What is the Japanese industry association sponsor of ICH?
Answer:
Japanese Pharmaceutical Manufacturers Asssociation
Q: What is the American industry association sponsor of ICH?
Answer:
Pharmaceutical Research and Manufacturers of America
Q: What organizations are represented on the ICH Steering Committee?
Answer:
- representatives from each of the ICH sponsors
- IFPMA (International Federation of Pharmaceutical Manufacturers Association)
- World Health Organization (WHO)
- Canadian Health Protection Branch
- European Free Trade Area
Q: Representatives from each of the ICH sponsors, IFPMA (International Federation of
Pharmaceutical Manufacturers Association), World Health Organization (WHO), Canadian
Health Protection Branch, and European Free Trade Area are all organizations represented on the
_?
Answer:
ICH Steering Committee
Q: True or False? The ICH guideline should be followed when generating data that will be
submitted to a regulatory authority and when conduction investigations that involve therapeutic
interventions in, or observations of human subjects.
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What is the purpose of the ICH’s Good Clinical Practice: consolidated Guideline? To define Good clinical practice and provide a unified standard for designing, conduction, recording and reporting trials that involve participation of human subjects.
What guideline’s purpose is to define Good clinical practice and provide a unified standard for designing, conduction, recording and reporting trials that involve participation of human subjects? ICH’s Good Clinical Practice: Consolidated Guideline
What bearing does the ICH’s Good Clinical Practice: Consolidated Guideline have on the Investigator’s Brochure? Describes the minimum information that should be included in an Investigator’s Brochure (IB) and provides a suggested format.
What guideline describes the minimum information that should be included in an Investigator’s Brochure (IB) and provides a suggested format? ICH’s Good Clinical Practice: Consolidated Guideline
What bearing does the ICH guideline have on the conduct of a clinical study and the acceptability of data? Describes the documents required individually and collectively to permit evaluation of the study conduct and data quality
What document describes the documents required to permit evaluation of the study conduct and data quality? ICH Good Clinical Practice
What are the 3 regulatory agency sponsors of the ICH? European Commission, the Japanese Ministry of Health adn Welfare, and the CDER and CBER of the FDA
The European Commission, the Japanese Ministry of Health adn Welfare, and the CDER and CBER of the FDA are the _ of the ICH. regulatory agency sponsors What 2 parts of the FDA are the american agency sponsors of the ICH? CDER and CBER What does CDER stand for? Center for Drug Evaluation and Research What does CBER stand for? Center for Biologics Evaluation and Research What is the central goal of the harmonization effort? To identify and then reduce differences in technical requirements for drug development among regulatory agencies What organization’s goal is to identify and then reduce differences in technical requirements for drug development among regulatory agencies? harmonization effort Why was the ICH organized? to provide an opportunity for development of tripartite harmonization initiatives based on input from both regulatory and industry representatives What organization was created to provide an opportunity for development of tripartite harmonization initiatives based on input from both regulatory and industry representatives ICH (International Conference on Harmonization) What does ICH stand for? International Conference on Harmonization The ICH seeks to harmonize requirements from which three regions? European Union, Japan, United States The ICH is concerned with harmonization of with the European Union, Japan, and the United states technical requirements for registration of pharmaceutical products
The ICH Secretariat coordinates _ documentation. ICH What organization is the ICH Secretariat affiliated? The international Federation of Pharmaceutical Manufacturers Association (IFPMA) What does IFPMA stand for? International Federation of Pharmaceutical Manufacturers Association The IFPMA is associated with which part of ICH? ICH Secretariat What are the three industry association sponsors of ICH? European Federation of Pharmaceutical Industries AssociationJapanese Pharmaceutical Manufacturers AssociationPharmaceutical Research and Manufacturers of America What is the European industry association sponsor of ICH? European Federation of Pharmaceutical Industries Association What is the Japanese industry association sponsor of ICH? Japanese Pharmaceutical Manufacturers Asssociation What is the American industry association sponsor of ICH? Pharmaceutical Research and Manufacturers of America What organizations are represented on the ICH Steering Committee? 1. representatives from each of the ICH sponsors2. IFPMA (International Federation of Pharmaceutical Manufacturers Association)3. World Health Organization (WHO)4. Canadian Health Protection Branch5. European Free Trade Area Representatives from each of the ICH sponsors, IFPMA (International Federation of Pharmaceutical Manufacturers Association), World Health Organization (WHO), Canadian Health Protection Branch, and European Free Trade Area are all organizations represented on the ? ICH Steering Committee
True or False? The ICH guideline should be followed when generating data that will be submitted to a regulatory authority and when conduction investigations that involve therapeutic interventions in, or observations of human subjects. True
True or False? The ICH guideline binds the regulatory agencies in Japan, the US, and Europe to particular actions False, (the guideline does not prohibit alternative approaches that satisfy the requirements of the applicable statutes, regulations or both.)
GCP compliance serves what function for the general public? assures public that the data is credible and that the rights, safety, and well being of trial subjects are protected and consistent with the Declaration of Helsinki principles
What assures the public that data is credible? GCP
What assures the public that the rights, safety, and well being of trial subjects are protected and consistent with Declaration of Helskinki? GCP
What does ADR stand for? Adverse Drug Reaction
What is and ADR? ADR = Adverse Drug Reactiona noxious and unintended response to a new medicinal product, a new usage of a medicinal product, or a marketed medicinal product
What is a noxious and unintended response to a new medicinal product, a new usage of a medicinal product, or a marketed medicinal product? ADR (adverse drug reaction)
True or False: To be classified as an Adverse Drug Reaction, a causal relationship between a medicinal product and an unintended response to that product must be at least a reasonable possibility. True
What is required in order to classify an event as an Adverse Drug Reaction? a reasonable possibility of a causal relationship between a medicinal product and unintended response to that product
Is ADR (Adverse Drug Reaction) synonymous with AE (Adverse Event)? No (AE is a broader concept, including any unfavorable medicinal occurrence regardless of its relationship to the medicinal product)
What is the term used to describe law(s) and regulation(s) governing the conduct of clinical trails in particular jurisdiction Applicable Regulatory Requirements
The Code provides 10 directives for human experimentation Nuremberg Code
10 Directives for Human Experimentation (Nuremberg Code) 1. Voluntary consent of the human subject is absolutely essential2. The experiment must yield generalizable knowledge that could not be obtained in any other way and is not random and unnecessary in nature3. Animal experimentation should precede human experimentation4. All unnecessary physical and mental suffering and injury should be avoided5. No experiment should be conducted if there is reason to believe that death or disabling injury will occur6. The degree of risk to subjects should never exceed the humanitarian importance of the problem7. Risks to the subjects should be minimized through proper preparations8. Experiments should only be conducted by scientifically qualified investigators9. Subjects should always be at liberty to withdraw from experiments10. Investigators must be ready to end the experiment at any stage if there is cause to believe that continuing the experiment is likely to result in injury, disability or death to the subject
3 principles essential to the Belmont Report 1. respect for person2. beneficence3. justice
2 meanings of beneficent actions do no harm, maximize possible benefits and minimize possible harms
Justice requires that individuals and groups be treated fairly and equitably in terms of bearing the burdens and receiving the benefits of research
What does CFR stand for? Code of Federal Regulations
The ethical principles for research involving human subjects described in the Belmont Report are codified in the _, specifically _ CFR (code of federal regulations), specifically 45 CFR 46
What does subpart A of the HHS regulation define? Basic HHS Policy for Protection of Human Research Subjects
What is supbart A also known as? The Common Rule
What does subpart B of the HHS regulation define? Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
What does subpart C of the HHS regulation define? Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
What does subpart D of the HHS regulation define? Additional Protections for Children Involved as Subjects in Research
What does subpart E of the HHS regulation define? Registration of Institutional Review Boards
How does Subpart A define a human subject? “as a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information.”””
How does subpart A define research a systematic investigation…designed to develop or contribute to generalizable knowledge
What subparts apply to individuals with diminished autonomy? Subpart B (pregnant women, fetuses, and neonates)Subpart C (prisoners)Supbard D (children)
What are examples of vulnerable populations? mentally disabled persons, economically or educationally disadvantaged persons, pregnant women, children, fetuses, neonates, prisoners
yes or no: Does subpart C (prisoners) apply to the following situation?A study proposes to observe the challenges for former prisoners returning to office jobs. Researchers will recruit individuals who have spent over ten years in prison, have completed their sentences, and are now interviewing for office jobs. no, the participants in this research are no longer considered prisoners.
Yes or No: Does Subpart D (Children) apply to the following situation?A study proposes to examine the effectiveness of a medical treatment and prevention program for adolescents in a location where the legal age for consent to such treatment is 12. The adolescents involved range from ages 12 to 17. No, The regulatory definition of children depends both on the local laws and on the specific treatments or procedures that will be involved in the research. Because the location in which the research will be conducted allows 12-year-olds to consent to the treatment, the participants in this research are not considered children under the HHS regulations and can provide informed consent to participate in the study. While the regulations do not require the additional protections of Subpart D for children in this study, the IRB may require some additional protections if they feel that the adolescents who will be involved in the study are vulnerable.
What is the minimum # of members for an IRB? 5
What are the two basic ideas of respect for persons? 1. Individuals should be treated as autonomous agents2. Persons with diminished autonomy are entitled to additional protections
3 fundamental aspects of informed consent are: voluntariness, comprehension, disclosure
What 8 things must be disclosed by the researcher in the informed consent? 1. The purpose of the study2.Any reasonably foreseeable risks to the individual3. Potential benefits to the individual or others4. Alternatives to the research protocol5. The extent of confidentiality protections for the individual6. Compensation in case of injury due to the protocol7. Contact information for questions regarding the study, participants’ rights, and in case of injury8. The conditions of participation, including right to refuse or withdraw without penalty
What criteria must be met for IRB to waive or alter some or all of the required elements of IC? “1. “”The research involves no more than minimal risk to the subjects2. The waiver or alteration will not adversely affect the rights and welfare of the subjects3. The research could not practicably be carried out without the waiver or alteration4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation”””
Whata re the 5 most common categories of risk to research participants? Physical, psychological, social, legal, economic
define physical risk Physical risks may include pain, injury, and impairment of a sense such as touch or sight. These risks may be brief or extended, temporary or permanent, occur during participation in the research or arise after.
define psychological risk Psychological risks can include anxiety, sadness, regret and emotional distress, among others. Psychological risks exist in many different types of research in addition to behavioral studies.
define social risk Social risks exist whenever there is the possibility that participating in research or the revelation of data collected by investigators in the course of the research, if disclosed to individuals or entities outside of the research, could negatively impact others’ perceptions of the participant. Social risks can range from jeopardizing the individual’s reputation and social standing, to placing the individual at-risk of political or social reprisals.
define legal risk “Legal risks include the exposure of activities of a research subject “”that could reasonably place the subjects at risk of criminal or civil liability.”” 4″
define economic risk Economic risks may exist if knowledge of one’s participation in research, for example, could make it difficult for a research participant to retain a job or to find a job, or if insurance premiums increase or loss of insurance is a result of the disclosure of research data.
define minimal risk “Minimal risk is defined in the Common Rule to be “”that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”” (45 CFR 46.102(i))”
therapeutic misconception “the tendency for research participants to””… downplay or ignore the risks posed to their own well-being by participation … [due to] the participants’ deeply held and nearly unshakeable conviction that every aspect of their participation in research has been designed for their own individual benefit””. 6″
Equipoise Substantial scientific uncertainty about which treatments will benefit subjects most, or a lack of consensus in the field that one intervention is superior to another.
Major roles of IRBs 1. Initial review and approval or disapproval of the proposed research activity2. Ensuring that the proposed informed consent process meets all of the requirements of 45 CFR 46.1163. Providing continuing oversight for progress reports and protocols for ongoing research studies
6 purposes of IRBs 1.Risks to human subjects are minimized2. Risks to human subjects are reasonable in relation to anticipated benefits, if any, to human subjects and the importance of the knowledge that may reasonably be expected to result from the research3. Selection of human subjects is equitable4. Informed consent will be sought from each prospective research participant or the prospective research participant’s legally authorized representative in accordance with and to the extent required by the HHS regulations (45 CFR 46.116)5. Informed consent will be appropriately documented in accordance with and to the extent required by the HHS regulations (45 CFR 46.117)6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of the human subjects, and when appropriate there are adequate provisions to protect the privacy of human subjects and to maintain the confidentiality of data
The NIH requires that all clinical trials supported by NIH have a plan. Data and Safety Monitoring (DSM)
2 components of justice 1. Fair procedures and outcomes are used to select research participants, and2. There is a fair distribution of benefits and burdens to populations who participate in research
What are the two types of justice defined by the Belmont report? individual justicesocial justice
Define individual justice “requires that investigators “”should not offer potentially beneficial research only to some patients who are in their favor or select only ‘undesirable’ persons for risky research.”””
define social justice “””requires that distinction be drawn between classes of subjects that ought, and ought not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens and on the appropriateness of placing further burdens on already burdened persons.”””
what is the difference between equitably and equally? “To treat “”equitably”” means to treat fairly;To treat means to treat in exactly the same way.”
define equitable treat fairly
define equally treat exactly the same way
what might effect the equitable distribution of a trial population? 1. May be affected by the disease or condition under study, and2. That are anticipated to benefit from the knowledge gained through the research
the NIH states that children be included in all NIH-supported human subject research… must
what are the 7 exceptions to the NIH policy that children must be included in research involving humans? 1. The research topic to be studied is irrelevant to children …2. There are laws or regulations barring the inclusion of children in the research …3. The knowledge is already available for children or will be obtained from another on-going study, and an additional study will be redundant …4. A separate, age-specific study in children is warranted and preferable …5. Insufficient data are available in adults to judge potential risk in children … in some instances, the nature and seriousness of the illness may warrant [children’s] participation based on careful risk and benefit analysis …6. The study design is aimed at collecting additional data on pre-enrolled adult study participants …7. Other special cases justified by the investigator and found acceptable to the review group and Institute Director
How does the HHS regulation define children? “Subpart D: “”persons who have not attained the legal age for consent to treatment”””
How does the NIH Inclusion Policy define children Under the age of 18
“Therapeutic misconception or deception?The tendency for research participants to: “”downplay or ignore the risks posed to their own well-being by participation…[due to] the participants’ deeply held and nearly unshakeable conviction that every aspect of their participation in research has been designed for their own individual benefit.””” therapeutic misconception
Therapeutic misconception or deception?Misleading research participants about the research purpose or procedures. Deception
Regarding placebo, what 3 things must the IC disclose to ensure the subject’s understanding? 1. Understand what placebos are2. Understand the likelihood that they will receive a placebo3. Are able to provide their fully informed consent that they are willing to receive a placebo
What are 4 examples of justifications for the use of placebos? 1. When there are no approved, effective treatments for the condition, or2. If there is disagreement about whether standard treatment is better than placebo, or3 .When the additional risk posed by the use of placebo is minor and withholding the current standard therapy would not lead to serious or permanent harm, or4. If the study is anticipated to result in widespread or major benefits and the receipt of placebo by individuals poses minimal risk
What 3 things must be considered if incoplete disclosure or deception are to be used? 1. Whether the scientific goals of the research can be achieved by methods that do not involve incomplete disclosure or deception2. Whether participants would consider the information withheld during the informed consent process important to their decision to participate in the study3. Whether it is possible to inform participants that they will only learn about all the goals of the research after the research study is over
in what 4 situations does HHS allow IC to be waived? 1. Participation in the research involves no more than minimal risk2. The waiver must not adversely affect the rights and welfare of research participants3. Incomplete disclosure or deception must be essential to the ability to carry out the research4. Whenever appropriate, research participants will be given additional pertinent information after they have participated in such a study (debriefing)
ICH guidelines have how many categories? 4 categories
what are the 4 categories of ICH guidelines? Quality, Safety, Efficacy, Multidisciplinary
What do the quality guidelines of ICH involve? GMP (good manufacturing practice)considerations for stability studies and defining threshold for impurities
What do the safety guidelines of ICH involve? uncover potential risks (ex: carcinogenicity, genotoxicity, reprotoxicity)describe tests needed to support clinical testing
What do the efficacy guidelines of ICH involve? the design, conduct, safety, and reporting of biotechnological processes and the use of pharmacogenetics/pharmacogenomics techniques to produce better targeted meds
What do the multidisciplinary guidelines of ICH involve? govern topics that don’t fit into Quality, safety, or efficacy(cover ICH medical terminology MedDRA, CTD common technical document, and electronic standards for the Transfer of Regulatory Information ESTRI)
E6 2.1 comply with ethical principles, GCP, and regulatory requirements
E6 2.2 assess risk and benefits before starting or continuing clinical study
E6 2.3 always prioritize rights, safety, and well-being of the subject
E6 2.6 adhere to the protocol and institutional review board/independent ethics committe has approved
E6 2.9 Obtain IC from every trial subject
E6 2.12 manufacture and manage IP by adhering to best manufacturing practice
E5 2.13 implement systems and procedures to assure the quality of every aspect of trial
E6 2.4 clinical and non-clincial info should support teh proposed trial
E6 2.5 trials should be scientifically sound and well described
E6 2.10 data generate should be robust and verifiable
E6 2.11 confidentiality of subject data must be ensured
E6 2.7 qualified physicians are responsible for medical care of trial subjects
E6 2.8 only qualified individuals perform trial related functions
list essential docs: protocol, financial arrangement, approval to perform study, IB, info given to all trial subjects, CVs of relevent staff memebers, sample CRF, contract, sample lable of IP
Clinical Trial Agreement (CTA) signed agreement that outliens the requirements, scope of work, and expected behavior to be executed during a trial.
Trial Master File compilation of documents that helps evaluate the conduct of a trial and the quality of the data
Investigator’s Brochure compilation of known and relevant data on the drug from non-clinical and clinical testing performed during research
Informed Consent Form document that describes the research that the patient/volunteer would be taking part in
Sponsor Definition an individual, company, institution, or organization taht takes responsibility for the initiation, management, and/or financing of a clinical trial
an individual investigator that is also the sponsor is called a ? Sponsor-investigator
Sponsors can be from , , , , , or pharmaceutical, device, biologics companies, academic institutions, organizations, or governmental bodies
CRO stands for Contract Research Organziation
Adverse Event define any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.
what are the 3 criteria used to sub-categorize adverse events? seriousness, relatedness/causalityexpectedness
Serious adverse event any untoward medical occurrence that, at any dose, can have any of the following outcomes: – death- life-threatening- requires in-patient hospitalization or prolongation of existing hospitalization- results in persistent or significant disability/incapacity- is a congenital anomaly/birth defect
relatedness of an AE refers to? whether or not it is believed that the IP caused the event
expectedness of an AE refers to what? whether or not the event has been observed in previous clinical trials (IB is primary source used to determine expectedness of events)
non-serious expected AE doesn’t meet definition of SAE but was previously reproted and documented in the IB
non-serious, unexpected AE doesn’t meet definition of SAE and was NOT documented in the IB
what type of AE is the following example?an event was reported in the IB as mild, but now it is observed to be of greater severity unexpected AE
serious expected AE an event that meets the definition of an SAE and was previously reported in the IB
Serious unexpected AE an event that meets the definition of SAE but was NOT documented in the IB
source data definition all info in original records or certified copies of clinical findings, observations or other activities that would enable reconstruction and evaluation of the trial.
what must be included in the ICF for the sponsor to be able to review the medical records of a subject? the ICF must include a statement that sponsor personnel will ahve access to the medical records of a subject and the subject must consent to this
what do auditors do? offer quality assurance, assess the overall compliance of a trial
auditors perform audits at the , and level sites, CRO, and sponsor level IP shipping records must include documentation of shipment, receipt, disposition, return, and destruction does the following describe an ADR, AE, Serious AE, or Serious ADRmoderate heartburn, onset within 1 hours of taking IP and manages with meds at home. subject remembers reading IC that there is high lieklihood of heartburn due to drug mechanism of action ADR (adverse drug reaction) does the following describe an ADR, AE, serious AE or Serious ADRwhile receiving the IP via infusion the subject exhibits signs of anaphylactic reaction Serious ADR does the following describe an ADR, AE, serious AE or Serious ADRfall resulting in a broken hip that requries the subject to be hospitalized; the subject has a history of falling prior to starting clin trial SAE does the following describe an ADR, AE, serious AE or Serious ADRin a clin trial of anti-epileptic drug that is associated with many birth defects, subjects are required to use highly effective contraception. a subject becomes pregnant and delivers a baby that appears healthy and normal on delivery Adverse event IRB stands for International Review Board IEC stands for Independent Ethics Committee Main purpose of IRB/IEC protect rights, safety and well-being of subjects IRB/IEC must approve which 6 documents? Protocol (and amendments), IC (and updates), any writen info given to subjects, advertisements for recruitment, subject compensation, case report form (if applicable) IC must be signed by or _ the study subject or their LAR (legally acceptable representative) LAR stands for legally acceptable representative IC when subject’s dont speak the langauge every effort must be made to obtain the IC in the subject’s preferred language IC when subject’s cant read an impartial witness should be present during the ENTIRE consent discussion. the witness would need to sign and attest that the info in the consent form was explained to the subject or LAR at minimum how often must a progress report be submitted to the IRB annually any event considered related to the IP will be regarded as a Adverse drug reaction
an SAE that is considered related to the IP will be regarded as a __ serious drug reaction
in an end-stage oncology trial where death is an expected event for the patient population the protocol may indicate that deaths due to disease progression do not require immediate reporting True or False TRUE
the subject identification code list is NOT shared with the sponsor to ensure subject confidentiality TRUE OR FALSE TRUE
TRUE or False The language used in IC should be non-technical and understandable TRUE
TRUE or FALSE every subject must be given opportunity to review and consider the study and ask any questions they have TRUE
TRUE or FALSE to document that the informed consent was obtained, only the subject needs to sign the ICF FALSE
TRUE or FALSEone copy of hte signed IC is required for the trial and it always remains at the site FALSE
IRB must maintain records for how many years after the end of a study? 3 years