SoCRA Certification Exam SOCRA Certification SOCRA Practice Test SOCRA Exam Questions Socra Exam Prep Questions and Answers SOCRA CCRP Exam SoCRA (Actual Exam Questions and Answers)
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Laws -ANSWER- passed by national legislative bodies; establish authority of national regulatory body Regulations -ANSWER- Passed by regulatory authorities; controls how medical products are investigated and approved; have effect of law guidance -ANSWER- "current thinking" of regulatory bodie...
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Add to cartLaws -ANSWER- passed by national legislative bodies; establish authority of national regulatory body Regulations -ANSWER- Passed by regulatory authorities; controls how medical products are investigated and approved; have effect of law guidance -ANSWER- "current thinking" of regulatory bodie...
April 30 1996 - ANSWER-ICH GCP Development Date Quality - ANSWER-ICH Q Efficacy - ANSWER-ICH E Safety - ANSWER-ICH S Multidisciplinary - ANSWER-ICH M guidance for industry, consolidated guideance - ANSWER-ICH E 6 Clinical Safety Data Management Definitions and Standards - ANSWER-IC...
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Add to cartApril 30 1996 - ANSWER-ICH GCP Development Date Quality - ANSWER-ICH Q Efficacy - ANSWER-ICH E Safety - ANSWER-ICH S Multidisciplinary - ANSWER-ICH M guidance for industry, consolidated guideance - ANSWER-ICH E 6 Clinical Safety Data Management Definitions and Standards - ANSWER-IC...
Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - ANSWER-False. The general provisions for electeonic signature criteria apply to records that are i. Created, modified, maintained, archived, retrieved, or transmitted, in electronic fo...
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Add to cartElectronic signature are currently accepted for any and all records, paper or electronic form. True or False? - ANSWER-False. The general provisions for electeonic signature criteria apply to records that are i. Created, modified, maintained, archived, retrieved, or transmitted, in electronic fo...
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 01:30 01:35 If the investigator did have financial arrangement with the sponsor, he/she would submit the follo...
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Add to cartWhich 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 01:30 01:35 If the investigator did have financial arrangement with the sponsor, he/she would submit the follo...
Does the FDA consider electronic signatures to be as trustworthy and reliable as handwritten paper signatures? - ANSWER-Yes (although permission to use such e-sigs has to be approved by the FDA) Does the FDA consider electronic records that meet requirements to be equivalent to handwritten record...
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Add to cartDoes the FDA consider electronic signatures to be as trustworthy and reliable as handwritten paper signatures? - ANSWER-Yes (although permission to use such e-sigs has to be approved by the FDA) Does the FDA consider electronic records that meet requirements to be equivalent to handwritten record...
Biometrics - ANSWER-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 - ANSWER-An environment in...
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Add to cartBiometrics - ANSWER-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 - ANSWER-An environment in...
Electronic Records, Electronic Signatures - ANSWER CFR Title 21: Part 11 Informed Consent - ANSWER CFR Title 21: Part 50 Financial Disclosure - ANSWER CFR Title 21: Part 54 Instiutional Review Board - ANSWER CFR Title 21: Part 56 Investigational new Drug Application - ANSWER CFR Title 21...
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Add to cartElectronic Records, Electronic Signatures - ANSWER CFR Title 21: Part 11 Informed Consent - ANSWER CFR Title 21: Part 50 Financial Disclosure - ANSWER CFR Title 21: Part 54 Instiutional Review Board - ANSWER CFR Title 21: Part 56 Investigational new Drug Application - ANSWER CFR Title 21...
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