MEGA SOCRA CCRP Exam Content with complete solutions (Verified Answers) Latest 2023-2024, Exams of Nursing

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3 regulatory agency sponsors of ICH - ansEuropean Union, Japan, United States 21 CFR 11 - ansElectronic Records/Signatures 21 CFR 50 - ansProtection of Human Subjets/Informed Consent 21 CFR 56 - ansIRB 21 CFR 312 - ansIND 21 CFR 812 - ansIDE 45 CFR - ansThe Common Rule 45 CFR Part B - ansPregnant Women and Fetuses 45 CFR Part C - ansPrisoners 45 CFR Part D - ansChildren 45 CFR Part E - ansIRBs According to GCP guidelines, does the term vulnerable subject also include employees under direct supervision of clinical investigator? - ansYes According to ICH guidelines, how many members should an IRB have? - ansat least 5 According to ICH guidelines, IRB must retain records for... - ans3 years Act - ansThe Food, Drug and Cosmetic Act, as amended. Adverse Drug Reaction (ADR) - ansAll noxious and unintended responses to a medicinal product related to any dose. (ICH GCP E6 1.1) Adverse Event (AE) - ansAny untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. (ICH GCP E6 1.2) Applicable Regulatory Requirements - ansAny laws and regulations addressing the conduct of clinical trials of investigational products (ICH GCP E6 1.4) Are devices intended solely for veterinary use exempt form IDE regulations? - ansYes

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Assent - ansA child's affirmative agreement to participate in a clinical investigation. Mere failure to object may not, absent affirmative agreement, be construed as assent. (21 CFR, sec. 50.3) Audit - ansA systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsors SOPs, GCP and the applicable regulatory requirements. (ICH GCP E6 1.6) Audit Certificate - ansA declaration of the confirmation by the auditor that an audit has taken place. (ICH GCP E6 1.7) Audit Report - ansA written evaluation by the sponsor's auditor of the results of the audit. (ICH GCP E6 1.8) Audit Trail - ansDocumentation that allow reconstruction of the course of events. (ICH GCP E6 1.9) Belmont Report - ans Biometrics - ansA method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) Blinding/Masking - ansA procedure in which one or more parties to the trial are kept unaware of the treatment assignment. (ICH GCP E6 1.10) Case Report Form (CRF) - ansA printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject. (ICH GCP E6 1.11) Certification - ansThe official notification by the institution to the supporting department or agency, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance. (45 CFR, sec. 46.102) Children - ansPersons who have not attained the legal age for consent to treatment or procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the clinical investigation will be conducted. (21 CFR, sec. 50.3) Circumstances/conditions required for informed consent - ans- subject has had sufficient opportunity to consider whether to participate

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• the possibility of coercion or undue influence is minimized Class I Device - ansLow risk, examples include bandages, exam gloves, Q-tips Class II Device - ansMedium risk, examples include powered wheelchairs, infusion pumps, surgical drapes Class III Device - ansHighest risk, examples include heart valves, breast implants, pacemakers Clinical Investigation - ansAny experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the Act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. (21 CFR, sec. 50.3) Clinical Trial/Study Report - ansA written description of a trial/study of any therapeutic, prophylactic or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analysis are fully integrated into a single report. (ICH GCP E6 1.13) Closed System - ansAn environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. ( CFR, Sec. 11.3) Comparator (Product) - ansAn investigational or marketed product (i.e. active control). or placebo, used as a reference in a clinical trial. (ICH GCP E6 1.14) Compliance - ansAdherence to all the trial related requirements, GCP requirements and the applicable regulatory requirements. (ICH GCP E6 1.15) Confidentiality - ansPrevention or disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity. (ICH GCP E6 1.16) Contract - ansA written, dated and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and if appropriate on financial matters. (ICH GCP E6 1.17) Contract Research Organization - ansA person that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of

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a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the FDA. (21 CFR, sec. 312.3) Contract Research Organization (CRO) - ansA person or an organization (commercial academic or otherwise) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. (ICH GCP E6 1.20) Coordinating Committee - ansA committee that a sponsor may organize to coordinate the conduct of a multicentre trial. (ICH GCP E6 1.18) Coordinating Investigator - ansAn investigator assigned the responsibility for the coordination of investogators at different centres participating in a multicentre trial. (ICH GCP E6 1.19) Custom Device - ansA device that 1) necessarily deviates from devices generally available 2) is not generally available to Physicians/dentists 3) not generally available in finished form for purchase or dispensing 4) is not offered for commercial distribution through labeling/advertising 5) is intended for use by an individual patient named in the order of the physician or dentist and is made to be in a specific form for that patient. ( CFR, sec. 812.3) Declaration of Helsinki - ans Department of Agency Head - ansThe head of any federal department or agency and any other officer or employee of any department or agency to whom authority has been delegated. (45 CFR, sec. 46.102) Digital Signature - ansAn electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified. (21 CFR, Sec. 11.3) Direct Access - ansPermission to examine, analyze, verify, and reproduce any records and reports that are important to the evaluation of a clinical trial. (ICH GCP E6 1.21) Documentation - ansAll records, in any form, that describe or record the methods, conduct and or results of a trial, the factors affecting the trial and the actions taken. (ICH GCP E6 1.22) Electronic Record - ansAny combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved or distributed by a computer system. (21 CFR, Sec. 11.3)

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Electronic Signature - ansA computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be legally binding equivalent of the handwritten signature. (21 CFR, Sec. 11.3) Emergency Use - ansThe use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is no sufficient time to obtain IRB approval. (21 CFR, sec. 56.102) Essential Documents - ansDocuments which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. (ICH GCP E 1.23) Family Member - ansAny one of the following legally competent persons: spouse; parents; children (including adopted children); brothers, sisters and spouses of brothers and sisters; and any individual related by blood or affinity whose close association with the subject is equivalent of a family relationship. (21 CFR, sec. 50.3) Form 482 - ansNotice of inspection Form 483 - ansInspectional observations Form 1571 - ansCover sheet for an IND application Form 1572 - ansStatement of investigator for IND Form 3454 - ansCertification of financial interest and arrangements of clinical investigators Form 3455 - ansDisclosure of financial interest and arrangements of clinical investigators Form 3500 - ansVoluntary safety reporting of adverse events and product problems Form 3500A - ansMandatory safety reporting by user facilities, distributors, and manufacturers GCP and HIPAA - ans Good Clinical Practice (GCP) - ansA standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of the trial subjects are protected. (ICH GCP E6 1.24)

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Guardian - ansAn individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care when general medical care includes research. (21 CFR, sec. 50.3) Handwritten Signature - ansThe scripted name or legal mark of an individual handwritten by that individual. (21 CFR, Sec. 11.3) HHS and FDA Revise Regulations - ans How many calendar days does a sponsor have to report a fatal or life-threatening unexpected adverse drug reaction? - ans7 calendar days Human Subject - ansA living individual about whom an investigator conducting research obtains 1)Data through intervention or interaction with the individual 2) Identifiable private information. (45 CFR, sec. 46.102) Human Subject - ansAn individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. (21 CFR, sec. 50.3) Impartial Witness - ansA person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject's LAR cannot read, and who reads the informaed consent for, and any other written information supplied to the subject. (ICH GCP E6 1.26) Implant - ansA device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more. (21 CFR, sec. 812.3) IND - ansAn investigational new drug application. Is synonymous with "Notice of Claimed Investigational Exemption for a New Drug". (21 CFR, sec. 312.3) Independent Data Monitoring Committee (IDMC) - ansMay be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints. (ICH GCP E6 1.25) Independent Ethics Committee (IEC) - ansA review panel the is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation and is adequately constituted to provide assurance of that protection. An IRB is one type of IEC. (21 CFR, sec. 312.3) Independent Ethics Committee (IEC) - ansAn independent body (a review board or a committee, institutional, regional, national or supranational), constitutes fo medical

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professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among, other things, reviewing and approving/providing favourable opinion on, the trial protocol, the suitability of the investigators, facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. (ICH GCP E6 1.27) Informed Consent ADDITIONAL Elements: - ans- risk to embyro or fetus

• termination procedures
• costs to study subjects
• approximate number of study subjects
• a statement of new findings when they may impact a subject's willingness to participate Informed Consent MUST Contain: - ans- explanation of purpose of research
• duration of participation
• description of procedures to be followed
• identification of any procedures which are experimental
• any foreseeable risks or discomfort
• statement about potential benefits to subjects
• statement if no reasonable alternative procedures or treatments are available to subjects
• for > minimal risk, a statement about compensation and if medical treatment is available for injuries
• statement of who to contact in the event of research-related injury Inspection - ansThe act by a regulatory authority of conducting and official review of documents, facilities, records and any other resources that are deemed by the authorities to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organizations (CROs) facilities, or at other establishments deemed appropriate by the regulatory authorities. (ICH GCP E6 1.29) Institution - ansAny public or private entity or agency (including Federal, State or other agencies). The word facility as used in section 520(g) of the Act is deemed to by synonymous with the term institution for purposes of this part.(21 CFR, sec. 50.3) Institutional Review Board (IRB) - ansAny board, committee, or other group formally designated by an institution to review biomedical research involving humans as subjects, to approve the initiation of and conduct periodic review of such research. The term has the same meaning as the phrase institutional review committee as used in section 520(g) of the act. (21 CFR, sec. 50.3)

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Interim Clinical Trial/Study Report - ansA report of intermediate results and their evaluation based on analyses performed during the course of the trial. (ICH GCP E 1.32) Investigational Device - ansA device, including a transitional device that is the object of investigation. (21 CFR, sec. 812.3) Investigational Product - ansA pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trail, including a product with a marketing authorization when used or assembled in a different way from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. (ICH GCP E6 1.33) Investigator - ansAn individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team. (21 CFR, sec. 50.3) Investigator's Brochure - ansA compilation of the clinical and nonclinical data on the investigational products which is relevant to the study of the investigational products in human subjects. (ICH GCP E6 1.36) IRB Approval - ansThe 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. (21 CFR, sec. 56.102) IRB membership requirements according to 45 CFR 46 - ans- minimum of 5 members

• IRB must be qualified through experience, expertise, diversity
• diversity with respect to race, gender, cultural background
• cannot consist of members of one profession
• at least one member must have a primary concern in a scientific area and one in a non-scientific area
• at least one member not affiliated with the institution Legally Acceptable Representative - ansAn individual or juridicial or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subjects participation in the clinical trial. (ICH GCP E6 1.37) Legally Authorized Representative - ansAn individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedures involved. (21 CFR, sec. 50.3)

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Legally Authorized Representative (LAR) - ansAn individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedures involved in the research. (45 CFR, sec. 46.102) Minimal Risk - ansMeans that the probability and magnitude of harm or discomfort anticipated in the research are no greater in an of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (21 CFR, sec. 50.3) Minimum risk - ansthe probability and magnitude of anticipated harm or discomfort 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. Monitor - ansWhen used as a noun, means an individual designated by a sponsor or contract research organization to oversee the progress of and investigation. When used as a verb, means to oversee and investigation. (21 CFR, sec. 812.3) Monitoring Report - ansA written report from the monitor or sponsor after each site visit and/or other trial-related communication according to the sponsor's SOPs. (ICH GCP E6 1.39) Multicentre Trial - ansA clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator. (ICH GCP E 1.40) Nonclinical Study - ansBiomedical studies not performed on human subjects. (ICH GCP E6 1.41) Noninvasive diagnostic device or procedure - ansOne that does NOT 1) penetrate the skin or mucous membranes of the body, ocular cavity or the urethra 2) enter the ear beyond the external auditory canal, the nose beyond the nares, the mouth beyond the pharynx, the anal canal beyond the rectum or the vagina beyond the cervical os. ( CFR, sec. 812.3) Nuremberg Code - ans OHRP - ans Open system - ansAn environment in which system access is not controlled by persons who are responsible for the content of the electronic records that are on the system. ( CFR, Sec. 11.3) Oral consent - ans- requires a witness

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• subject must sign short form only
• witness must sign both short form and summary of what was said Parent - ansA child's biological or adoptive parent. (21 CFR, sec. 50.3) Permission - ansThe agreement of the parent(s) or guardian to the participation of their child or ward in a clinical investigation. Permission must be obtained in compliance with part 50 subpart B and must include all the elements of the informed consent. (21 CFR, sec. 50.3) Phase I Clinical Trial - ansSmall trials with healthy subjects, purpose is to determine pharmacokinetics and maximum tolerated dose Phase II Clinical Trial - ansInitial demonstration of efficacy in patients, short-term safety information Phase III Clinical Trial - ansUse in large numbers of patients, long-term safety Phase IV Clinical Trial - ansPost-marketing, continue assessing therapeutic value and monitor less common adverse events Private Information - ans- information about behavior which occurs in a context in which an individual can reasonably expect that no observation or recording is taking place
• information which has been provided for a specified purpose by an individual and which the individual can reasonably expect will not be made public (e.g. medical record) Protocol Amendment - ansA written description of changes to or formal clarification of a protocol. (ICH GCP E6 1.45) Publication of Common Rule - ans Publication of FDA Regulations - ans Quality Assurance (QA) - ansAll those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented, and reported in compliance with Good Clinical Practices and the applicable regulatory requirements. (ICH GCP E6 1.46) Quality Control (QC) - ansThe operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial- related activities have been fulfilled. (ICH GCP E6 1.47)

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Randomization - ansThe process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. (ICH GCP E6 1.48) Regulatory Authorities - ansBodies having the power to regulate. In the ICH GCP guideline that guidelines the expression Regulatory Authorities includes the authorities that review submitted clinical data. Significant Risk Device - ansAn investigational device that 1) is intended as an implant and presents a potential for serious risk to the health, safety or welfare of the subject 2) is purposed or represented to be for a use in supporting or sustaining human life and presents a potential serious risk 3) is for a use of substantial importance in diagnosing, curing , mitigating or treating disease or otherwise preventing impairment of human health. (21 CFR, sec. 812.3) Sponsor - ansA person who initiates a clinical investigation but who does not actually conduct the investigation, i.e., the test article is administered or dispensed to, or used involving, a subject under the immediate direction of another individual. A person other than the individual (e.g., corporation or agency) that uses one or more of its own employees to conduct a clinical investigation it has initiated it has initiated is considered to be a sponsor (not a sponsor-investigator), and the employees are considered to be investigators. (21 CFR, sec. 50.3) Sponsor-Investigator - ansAn individual who both initiates and actually conducts, alone or with others, a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject. The term does not include any other person other than an individual, e.g. corporation or agency. (21 CFR, sec. 50.3) Termination - ansA discontinuance, b a sponsor or by withdrawal of IRB or FDA approval, of an investigation before completion. (21 CFR, sec. 812.3) Test Article - ansAny food or drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under sections 351, and 354- 360F of the Public Health Services Act. (21 CFR, sec. 50.3) Translational Device - ansA device that FDA considered to be a new drug or and antibiotic drug before May 28, 1976. (21 CFR, sec. 812.3) Types of federally-funded research that may be done using prisoners as subjects - ans- possible causes, effects, and processes of incarceration and criminal behavior

• prisons as institutional structures or prisoners as incarcerated persons

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• conditions particularly affecting prisoners
• practices aimed at improving the health or well-being of prisoners Unanticipated Adverse Device Event - ansAny serious adverse effect on the health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect or problem, or death was not previously identified in nature, severity or degree of incidence in the investigational plan or application. (21 CFR, sec. 812.3) Viable - ansAs it pertains to the neonate, means being able after delivery to survive. Waiver of Signed Informed Consent - ans- if the only record linking the subject to the research would be the consent document and the principal risk would result from breach in confidentiality
• the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the context of research Ward - ansA child who is placed in legal custody of the State or other agency, institution, or entity, consistent with applicable Federal, State or Local law. (21 CFR, sec. 50.3) What 5 classes of products do the informed consent regulations apply? (test articles) - ans- drugs
• medical devices
• biological products
• electronic products
• food (including dietary supplements and infant formulas)
• color additives What ethical standards are the ICH document based on? - ansDeclaration of Helsinki What special population must the IRB pay special attention to? - ansVulnerable subjects What was the purpose of the Belmont Report - ansprovide basic ethical principles, boundaries between practice and research What was the purpose of the Declaration of Helsinki - ansprovide ethical principles for the World Medical Association What was the purpose of the Nuremberg Code - ansprotect human subjects following the Nuremberg trials in which WWII Nazis were tried for human experimentation

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When does an SAE have to be reported to the FDA within 15 calendar days? - ansWhen it fits all SAE criteria but is not life-threatening and does not result in death. Where would you look to find official government information regarding GCP? - ansUS Code of Federal Regulations Who is responsible for the safety and well-being of all trial subjects? - ansthe IRB