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SOCRA CCRP Exam Practice 2024 QUESTIONS AND
ANSWERS Already Graded A+
____________________________ means any board, committee, or other group formally designated by an institution to review biomedical research involving subjects - ANS Institutional Review Board (IRB) 21 CFR part 11 refers to ___________. - ANS Electronic Records, electronic signatures 21 CFR part 11 regulates? - ANS Electronic Signatures 21 CFR part 312 refers to __________________. - ANS Investigational new drug application 21 CFR part 50 refers to ______________________. - ANS Protection of Human Subjects 21 CFR part 56 refers to _____________________. - ANS Institutional Review Board 21 CFR part 812 refers to ____________________. - ANS Investigational device exemptions 21CFR50 subpart B refers to ____________________? - ANS Informed consent 21CFR50, subpart D refers to safeguards for which population? - ANS Children in Clinical Investigations 45CFR46.116 is ___________________? A. General Requirements for informed consent. b. IRB Review of research c. Documentation of Informed Consent d. Criteria for IRB approval of research - ANS A: General Requirements for informed consent A _______ and ________ __ ________ __ __ ________ lists the investigator's education, training and experience that qualifies the investigator as an expert in the clinical investigation of the drug for use under investigation. - ANS 1. Curriculum vitae (CV)
- Statement of qualifications of the investigator A drug's safety is determined by what criteria? - ANS The dose at which no side effects are reported A purpose of monitoring clinical trials to verify that: - ANS The rights, safety, and well- being of human subjects are protected
A sponsor may transfer responsibility for any or all of the obligations to a(n) _____________________________. - ANS CRO (Contract Research Organization) A(n) __________________ is an investigational or marketed product, or placebo used as a reference in a clinical trial - ANS Comparator A(n) ____________________ can be any unfavorable and unintended sign (including an abnormal laboratory finding, symptom, or disease) temporally associated with the use of a medicinal (investigational) product whether 0r not related to the medicinal (investigational) product - ANS Adverse Event (AE) A(n) ____________________ is a printed, optical or electronic document designated to record all of the protocol required information to be reported to the sponsor on each trial subject - ANS Case report form According to the general principles of the Declaration of Helsinki, the responsibility for the protection of research subjects must always rest with the _____________________.
- ANS Physician All principles of GCP are conducted in accordance with _________________________________________________________. - ANS The Declaration of Helsinki An application for Investigational Device Exemption is part of 21 CFR part ____________? - ANS 812 Another name for ICH GCP is ________ _______, which refers to the integrity of the data. This series of ICH Guidelines is known as the Efficacy Guidelines. - ANS ICH E Before the investigation begins, the sponsor shall give the participating clinical investigator a(n) _________________________________. - ANS Investigators' Brochure CFR part 50 section 312 regulates? - ANS Investigational New Drug Define Clinical Investigation: - ANS Any experiment that involves a test article and one or more human subjects and that either:
- Is subject to requirements for prior submission to the FDA under section 505(i) or 520(g)
- Or is not subject to requirements for prior submission but the results of which are intended to be later submitted
- Or held by inspection by the FDA as a part of an application for a research or marketing permit
In 21CFR11.1, subpart A, what requirements must electronic records meet? - ANS They must be in accordance with part 11.2, unless paper records are specifically required In 21CFR50, subpart A, under general provisions, which part refers to an investigational new drug? - ANS Part 312 In 21CFR50, subpart B, there are _______ basic elements of informed consent. - ANS 8 In 21CFR50.24, when there has been exception from informed consent for emergency research, the proposed investigational plan must be based on __________________________________ in order for this exception to occur? - ANS Scientific Evidence In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered a(n) ______________________________. - ANS Adverse Drug Reaction IRB approval is granted when the following is determined: - ANS The determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements. IRB must register under which federal department? - ANS Department of Health and Human Services List 10 foundations of the ethical research of the Nuremberg Code - ANS 1. Voluntary consent of the human subject is absolutely essential.
- The experiment should yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature
- The experiment should be designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study, that the anticipated results will justify the performance of the experiment.
- The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
- No experiment should be conducted, where there is reason to believe that death or disabling injury will occur.
- The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
- Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
- The experiment should be conducted only by scientifically qualified persons with the highest degree of skill and care.
- During the course of the experiment, the human subject should be at liberty to bring the experiment to an end
- During the course of the experiment, the scientist in charge must be prepared to terminate the experiment at any stage List 4 requirements that make informed consent feasible when a signature cannot be obtained prior to investigation listed in 21CFR50: - ANS 1. The human subject is confronted by a life-threatening situation necessitating the use of the test article.
- Informed consent cannot be obtained from the subject because of an inability to communicate with the subject.
- Time is not sufficient to obtain consent from the subject's LAR.
- There is no available alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject Name significant device risks: (3 responses) - ANS 1. Purported or represented to be for a use in supporting or sustaining human life and presents a potential risk to health, safety, or the well-fare of the subject
- Is intended as an implant and presents a potential for serious risk to health, safety, or the well-fare of the subject
- For use of the substantial importance of diagnosing, curing, mitigating or treating disease or otherwise preventing impairment and presents potential risk to health, safety, or well-fare of the subject Name the 21CFR the regulates IRB Functions and Operations. A. 21CFR56.1-3 Subpart A B. 21CFR56.106 Subpart B C. 21CFR56.108 Subpart C D. 21CFR56.1115 Subpart D - ANS C. 21CFR56.108 Subpart C Name the 8 basic elements of informed consent - ANS 1. A statement that the study involves research
- Description of foreseeable risks
- Description of foreseeable benefits
- Disclosure of alternative procedures
- Statement of confidentiality
- When there is greater than minimal risk, an explanation of compensation or any medical treatments
- Explanation of whom to contact
- Statement the participation is voluntary Name the responsibility that falls under the jurisdiction of the Food and Drug Administration (FDA) - ANS Oversight of regulation adherence in clinical trials One of the three basic principles of the Belmont Report, Beneficence, is done through _____________ __ ______ ___ ___________. - ANS Assessment of Risks and Benefits
The contract research organization shall select a monitor that is qualified by _________________________ and __________________________. - ANS 1. Experience
- Training The FDA form 483 is used for __________. - ANS Inspectional Observations The initial drug dose is 110mg/m2. Due to toxicity, the drug needs to be decreased by 30%. What is the new dosage? - ANS 77 The international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects is known as ______________________________. - ANS Good Clinical Practice (GCP) The minimum number of Institutional Review Board (IRB) member is: - ANS 5 The responsibility for ensuring that the investigator understands a clinical trial lies with __________________________. - ANS The sponsor The sponsor obtains an agreement from the investigator/institution for adherence to the protocol, to obtain IRB approval, and GCP compliance. This agreement is known as ___________________. - ANS Form 1572 The sponsor shall notify the FDA by telephone or fax of any unexpected fatal or life- threatening experience associated with the use of the drug as soon as possible, but no later than _______________ after the sponsor's initial receipt of the information - ANS 7 calendar days (this is NOT working days) The three fundamental ethical principles for human subjects' research are: - ANS 1. Respect for Persons
- Beneficence
- Justice The World Medical Association (WMA) ethical principles for medical research involving human subject is called ________________________________. - ANS The Declaration of Helsinki There are ___________ principles of ICH GCP - ANS 13 There are 8 ICH GCP guidelines. The first is the glossary and the second is the principles of GCP. What are the other 6 guidelines? - ANS 3. IRB/IEC
- Investigator
- Sponsor
- Protocol and protocol amendments
- Investigator's Brochure
- Essential documents This form is used for the voluntary reporting of adverse events and product problems - ANS FDA Form 3500 True of False? 21CFR56.107 Subpart B is IRB Membership - ANS True True of False? ICH GCP principle 2.10 gives guidance about informed consent - ANS False. This principle covers guidelines referring to clinical trial information (data) and how it should be accurate in reporting, interpretation and verification. Principle 2.9 gives guidance about informed consent. True of False? Individuals invited to consult with the IRB on complex issues are allowed to vote as well. - ANS False. These members may not vote with the IRB True or False? 21CFR11.2, subpart A is only for electronic records required to be maintained that must be submitted to an agency. - ANS False. CFR part 11.2, subpart A is for electronic records maintenance when submitting to an agency and also when not submitting to an agency. True or False? 21CFR50 refers to protection of human rights that also regulate food additives - ANS True. This regulation governs:
- Foods, including dietary supplements, that bear a nutrient content claim or a health claim
- Infant formulas
- Food and color additives
- Drugs for human use
- Medical devices for human use
- Biological products for human use
- Electronic products. True or False? 21CFR56 is SPECIFICALLY related to IRB Functions and Operations - ANS False. 21 CFR 56 covers all IRB. 21CFR56 Subpart C is specifically related to IRB Functions and Operations True or False? 21CFR56 Subpart B is IRB Documentation - ANS False. 21CFR Subpart B is IRB organization and personnel True or False? Only the principle investigator is allowed to transcribe data from a source document to the CRF. - ANS False True or False? The 'Doctor's Trial prompted the Belmont Report - ANS False. The Belmont Report was prompted by Tuskegee Syphilis Study
What are the 8 parts of US Code of Federal Regulations Good Clinical Practice?? - ANS Part 11 (Electronic Records; Electronic Signatures) Part 50 (Informed Consent) Part 54 (Financial Disclosure) Part 56 (Institutional Review Boards) Part 312 (Investigational New Drug Application) Part 314 (New Drug Application) Part 812 (Investigational Device Exemption) Part 814 (Premarket Approval of Medical Devices) What are the three basic principles of the Belmont Report? - ANS Respect for persons Beneficence Justice What date should an investigator write when he/she failed to sign the consent form on the date of consent? - ANS Date of the investigator's signature What does 21CFR11, subpart B cover? - ANS Electronic Records What does 21CFR50 regulate? - ANS FDA Protection of Human Subjects What does 21CFR50 section 812 regulate? - ANS Investigational Device Exemptions What does 21CFR54 regulate? - ANS Financial disclosure by Clinical Investigators What does 21CFR56 regulate? - ANS Institutional Review Boards What does CBER stand for? - ANS Center for Biologics Evaluation and Research What is 21 CFR 50.24, subpart B? A. Exception from general requirements B. Elements of informed consent C. Exception from informed consent requirements for emergency research D. Documentation of informed consent - ANS C. Exception from Informed Consent Requirements for emergency research What is 21 CFR 50.56 Subpart D? - ANS Wards What is 21 CFR50.50 Subpart D? - ANS IRB Duties What is 21 CFR50.54, subpart D?
A. Clinical Investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. B. IRB duties - children C. Clinical Investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition - children D. Requirements for permission by parents or guardians and for assent by children. - ANS A. Clinical investigations not otherwise approvable that present opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. What is 21CFR50 Subpart B - ANS Informed Consent of Human Subjects What is 21CFR50 Subpart D? - ANS Additional Safeguards for children in clinical investigations What is 21CFR50.23 Subpart B? - ANS Exception from general requirements What is 21CFR50.25 Subpart B? A. General requirements for informed consent B. Documentation of informed consent C. Elements if Informed Consent E. Exception from general requirements - ANS C. Elements of Informed Consent What is 21CFR50.27 Subpart B? - ANS Documentation of informed consent What is 21CFR50.51 Subpart D? A. Wards B. Clinical Investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects - children C. Clinical investigations for not involving greater than minimal risk - children D. Clinical Investigations involving greater than minimal risk but presenting the prospect of no direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition - children - ANS C. Clinical Investigations not involving greater than minimal risk - children
What is 21CFR56.109 Subpart C? A. IRB functions and Operations B. IRB review of research C. Criteria for IRB approval of research D. Expedited review procedures for certain kinds of research involving no more than minimal risks, and for minor changes in approved research - ANS B. IRB review of research What is 21CFR56.110 Subpart C - ANS Expedited review procedures for certain kinds of research involving no more than minimal risk for minor changes in approved research What is 45CFR46 Subpart A - ANS Basic HHS policy for Protection of Human Research Subjects What is 45CFR46 Subpart B? A. Additional protections for pregnant women, human fetuses and neonates involved in research B. Additional protections pertaining to biomedical and behavioral research involving prisoners as subjects. C. Additional protections for children involved as subjects in research D. Registration of Institutional Review Boards - ANS A. Additional protections for pregnant women, human fetuses and neonates involved in research What is 45CFR46 Subpart C? - ANS Additional protections pertaining to biomedical and behavioral research involving prisoners as subjects What is 45CFR46? - ANS HHS - Protection of Human Subjects What is another name for ICH guideline is E6? - ANS GCP (Good Clinical Practice) What is defined as 'a pharmaceutical preparation that contains no active agent? - ANS Placebo What is form FDA 3455? - ANS Disclosures - Financial Interests and Agreements of Clinical Investigators What is form FDA 482 used for? - ANS Notice of Inspection
What is the FDA form 3454 - ANS Certification: Financial Interests and arrangements of Clinical Investigators What is the federal department responsible for helping people of Canada maintain and improve their health? - ANS Health Canada What is the minimum number of IRB members? - ANS 5 What is the mission of the ICH? - ANS Providing a unified standards for Europe, US and Japan to facilitate the acceptance of clinical trials What is the name of FDA Form 1572? - ANS Statement of Investigator What is the name of FDA Form 3454? - ANS Certification: Financial interests and arrangements of clinical investigators What is the name of FDA Form 3455? - ANS Disclosures: Financial interests and arrangements of clinical investigators What is the name of FDA Form 3500? - ANS For voluntary reporting of an adverse event and product problems What is the name of FDA Form 3500A - ANS For use by user-facilities, distributers and manufacturers for mandatory reporting (Mandatory reporting of serious adverse events) What is the name of FDA Form 482? - ANS Notice of Inspection What is the name of FDA Form 483? - ANS Inspectional Observation What is the person or organization (commercial, academic, or other) contracted by the sponsor of the clinical trial to perform one or more trial-related duty and function? - ANS Contract Research Organization (CRO) When can the IRB determine if expedited review can be used to approve a clinical investigation? (2 responses) - ANS 1) Some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk
- Minor changes in previously approved research during the period (of 1 year or less) for which approval is authorized. When can the IRB suspend or terminate approval? - ANS When research is not being conducted in accordance with IRB's requirements or that has been associated with unexpected serious harm to subjects
