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SOCRA CCRP Exam Practice 2024 QUESTIONS AND ANSWERS Already Graded A+
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____________________________ 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)
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 _____________________.
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 contract research organization shall select a monitor that is qualified by _________________________ and __________________________. - ANS 1. Experience
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