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SOCRA CCRP exam questions and answers already graded A+| Updated & Verified | 2024

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Timeline of Historical Events - Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report - respect for persons, beneficence, justice Application of Respect for Persons - informed consent (autonomy, choose for themselves) Application of Ben...

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Practice Questions for SOCRA exam questions and answers already graded A+| Updated & Verified | 2024

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Which of the following is a disclosure of financial interests form? - Which of the following is a certification of financial interest form? - If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - This form is submitted by sponsor to the...

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SoCRA Certification Test Questions and answers already graded A+| Updated & Verified | 2024

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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 ...

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SOCRA Exam questions and answers already graded A+| Updated & Verified | 2024

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Electronic Records - Use of electronic records must have procedures to ensure the authenticity, integrity and confidentiality of records. Also, the procedures must ensure the signer cannot readily repudiate the signed records a snot genuine Electronic Records - Audit Trail - Electronic records mu...

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SOCRA FDA timelines questions and answers already graded A+| Updated & Verified | 2024

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If immediate use of the test article (exception) is used to preserve the life of a subject and time is not sufficient to obtain IC, within X an independent physician should review the use of the article - 5 days If an article is used in an exempt way, this should be reported to the IRB in X after...

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SoCRA Study Guide exam questions and answers already graded A+| Updated & Verified | 2024

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IRB approval - 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 other institutional and federal requirements. Contract Research Organization (CRO) - a person that assumes, as an in...

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SOCRA Exam Questions and answers already graded A+| Updated & Verified | 2024

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Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - False. The general provisions for electeonic signature criteria apply to records that are i. Created, modified, maintained, archived, retrieved, or transmitted, in electronic form ii. T...

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SOCRA exam| 168 questions and answers already graded A+| Updated & Verified | 2024

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When isn't an IND application needed? IND Application is not needed if investigation does not support change in labeling. What information must the general IND include? (21 CFR Part 312.23) -FDA Form 1571 -FDA Form 1571 cover sheet -Table of contents -Investigative Plan -Investigator's broc...

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SOCRA Practice Test Questions and answers already graded A+| Updated & Verified | 2024

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Which of the following is a disclosure of financial interests form? - FDA Form 3455 Which of the following is a certification of financial interest form? - FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - FDA Form 3455 T...

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SoCRA Certification Test Questions and answers already graded A+| Updated & Verified | 2024

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SoCRA Certification Test Questions and answers already graded A+| Updated & Verified | 2024

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