SoCRA Certification Exam (Newest Version 2023 – 2024) With Complete Solution, Exams of Advanced Education

Download SoCRA Certification Exam (Newest Version 2023 – 2024) With Complete Solution and more Exams Advanced Education in PDF only on Docsity! SoCRA Certification Exam (Newest Version 2023 – 2024) With Complete Solution Biometrics - A 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) Closed System - An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3) Digital Signature - An 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) Electronic Record - Any 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) Electronic Signature - A 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) Open system - An 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. (21 CFR, Sec. 11.3) Clinical Investigation - 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 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) Investigator - An 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) Sponsor - A 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 - An 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) Handwritten Signature - The scripted name or legal mark of an individual handwritten by that individual. (21 CFR, Sec. 11.3) Act - The Food, Drug and Cosmetic Act, as amended. Human Subject - An 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) Institution - Any 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) - Any 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) Test Article - Any 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) Noninvasive diagnostic device or procedure - One 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. (21 CFR, sec. 812.3) Significant Risk Device - An 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) Termination - A discontinuance, b a sponsor or by withdrawal of IRB or FDA approval, of an investigation before completion. (21 CFR, sec. 812.3) Translational Device - A device that FDA considered to be a new drug or and antibiotic drug before May 28, 1976. (21 CFR, sec. 812.3) Unanticipated Adverse Device Event - Any 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) Department of Agency Head - The 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) Legally Authorized Representative (LAR) - An 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) Viable - As it pertains to the neonate, means being able after delivery to survive. Human Subject - A 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) Certification - The 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) Adverse Drug Reaction (ADR) - All noxious and unintended responses to a medicinal product related to any dose. (ICH GCP E6 1.1) Adverse Event (AE) - Any 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 - Any laws and regulations addressing the conduct of clinical trials of investigational products (ICH GCP E6 1.4) Audit - A 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 - A declaration of the confirmation by the auditor that an audit has taken place. (ICH GCP E6 1.7) Audit Report - A written evaluation by the sponsor's auditor of the results of the audit. (ICH GCP E6 1.8) Audit Trail - Documentation that allow reconstruction of the course of events. (ICH GCP E6 1.9) Blinding/Masking - A 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) - A 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) Clinical Trial/Study Report - A 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) Comparator (Product) - An investigational or marketed product (i.e. active control). or placebo, used as a reference in a clinical trial. (ICH GCP E6 1.14) Compliance - Adherence to all the trial related requirements, GCP requirements and the applicable regulatory requirements. (ICH GCP E6 1.15) Confidentiality - Prevention 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 - A 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) Coordinating Committee - A committee that a sponsor may organize to coordinate the conduct of a multicentre trial. (ICH GCP E6 1.18) Coordinating Investigator - An investigator assigned the responsibility for the coordination of investogators at different centres participating in a multicentre trial. (ICH GCP E6 1.19) Contract Research Organization (CRO) - A 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) Direct Access - Permission 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 - All 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) Form 1572 - Statement of investigator for IND Form 1571 - Cover sheet for an IND application Private Information - - 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) IRB membership requirements according to 45 CFR 46 - - 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 Circumstances/conditions required for informed consent - - subject has had sufficient opportunity to consider whether to participate - the possibility of coercion or undue influence is minimized Informed Consent MUST Contain: - - 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 Informed Consent ADDITIONAL Elements: - - 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 Oral consent - - requires a witness - subject must sign short form only - witness must sign both short form and summary of what was said Waiver of Signed Informed Consent - - 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 Types of federally-funded research that may be done using prisoners as subjects - - possible causes, effects, and processes of incarceration and criminal behavior - prisons as institutional structures or prisoners as incarcerated persons - conditions particularly affecting prisoners - practices aimed at improving the health or well-being of prisoners 3 regulatory agency sponsors of ICH - European Union, Japan, United States What ethical standards are the ICH document based on? - Declaration of Helsinki What special population must the IRB pay special attention to? - Vulnerable subjects What 5 classes of products do the informed consent regulations apply? (test articles) - - drugs - medical devices - biological products - electronic products - food (including dietary supplements and infant formulas) - color additives Minimum risk - the 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. Form 3454 - Certification of financial interest and arrangements of clinical investigators Form 482 - Notice of inspection Form 483 - Inspectional observations Form 3500 - Voluntary safety reporting of adverse events and product problems Form 3500A - Mandatory safety reporting by user facilities, distributors, and manufacturers Form 3455 - Disclosure of financial interest and arrangements of clinical investigators 21 CFR 312 - IND 21 CFR 812 - IDE Who is responsible for the safety and well-being of all trial subjects? - the IRB When does an SAE have to be reported to the FDA within 15 calendar days? - When it fits all SAE criteria but is not life-threatening and does not result in death. 21 CFR 50 - Protection of Human Subjets/Informed Consent