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SOCRA CCRP Exam AND practice exam UPDATE ACTUAL EXAM ALL QUESTIONS AND CORRECT DETAILED ANSWERS (VERIFIED ANSWERS) 100% PASS SOLUTION UNTIL NOW GRAD ED A+ $28.49
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SOCRA CCRP Exam AND practice exam UPDATE ACTUAL EXAM ALL QUESTIONS AND CORRECT DETAILED ANSWERS (VERIFIED ANSWERS) 100% PASS SOLUTION UNTIL NOW GRAD ED A+
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SOCRA CCRP
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SOCRA CCRP
SOCRA CCRP Exam AND practice exam UPDATE ACTUAL EXAM ALL QUESTIONS AND CORRECT DETAILED ANSWERS (VERIFIED ANSWERS) 100% PASS SOLUTION UNTIL NOW GRAD ED A+
SOCRA CCRP Exam AND practice exam UPDATE ACTUAL EXAM ALL QUESTIONS AND CORRECT DETAILED ANSWERS (VERIFIED ANSWERS) 100% PASS SOLUTION UNTIL NOW GRAD ED A + 2024 -2025 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 su bject 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 impair ment 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 dr ug 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 subjec t 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 admin istered 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 pro ducts (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 acco rding 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 evaluatio n 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 s ingle 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 infor mation or of a subject's identity. (ICH GCP E6 1.16)
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