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Certified Clinical Research Professional (CCRP) Exam
When isn't an IND application needed? - ANSWER 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) - ANSWER FDA Form 1571: -FDA Form 1571 cover sheet -Table of contents -Investigative plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/toxicology -Previous human research/literature information -Additional information (drug dependence and abus...
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When isn't an IND application needed? - ANSWER 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) - ANSWER FDA Form 1571: -FDA Form 1571 cover sheet -Table of contents -Investigative plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/toxicology -Previous human research/literature information -Additional information (drug dependence and abus...
SOCRA Practice Test Questions & Answers(RATED A+)
Which of the following is a disclosure of financial interests form? - ANSWER FDA Form 3455 Which of the following is a certification of financial interest form? - ANSWER FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - ANSWER FDA Form 3455
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Which of the following is a disclosure of financial interests form? - ANSWER FDA Form 3455 Which of the following is a certification of financial interest form? - ANSWER FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - ANSWER FDA Form 3455
SOCRA CCRP Certification Exam Correct 100%
Nuremburg Code - ANSWER The first set of principles outlining professional ethics for clinical research. Nuremburg Code elements - ANSWER 1. Voluntary informed consent 2. research benefits society 3. should be based on prior animal work 4. avoid suffering and injury 5. research where death and disabling injury is expected shouldn't be conducted 6. risks should be justified 7. proper preparations and adequate facilities 8. conducted by scientifically qualified 9. subjects can withd...
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Nuremburg Code - ANSWER The first set of principles outlining professional ethics for clinical research. Nuremburg Code elements - ANSWER 1. Voluntary informed consent 2. research benefits society 3. should be based on prior animal work 4. avoid suffering and injury 5. research where death and disabling injury is expected shouldn't be conducted 6. risks should be justified 7. proper preparations and adequate facilities 8. conducted by scientifically qualified 9. subjects can withd...
SOCRA Exam Questions & Solutions(RATED A+)
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 form ii. The criteria do not apply to paper records that are or have been transmitted by electronic means. If the electronic records meet the criteria specified in 21 CFR 11, thr agency will consi...
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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 form ii. The criteria do not apply to paper records that are or have been transmitted by electronic means. If the electronic records meet the criteria specified in 21 CFR 11, thr agency will consi...
SOCRA CCRP Certification Questions & Answers(Latest Update 2025)
CFR Title 21: Part 11 - ANSWER Electronic Records; Electronic Signatures Part 11, Subpart A: General Provisions - ANSWER -must be trustworthy, reliable, and generally equivalent to paper records -applies to electronic forms that are created, modified, maintained, archived, retrieved, or transmitted -where records meet requirements, it will be considered equivalent to full handwritten signatures, initials, etc. -must be available and subject to FDA inspection -may be in lieu of paper recor...
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CFR Title 21: Part 11 - ANSWER Electronic Records; Electronic Signatures Part 11, Subpart A: General Provisions - ANSWER -must be trustworthy, reliable, and generally equivalent to paper records -applies to electronic forms that are created, modified, maintained, archived, retrieved, or transmitted -where records meet requirements, it will be considered equivalent to full handwritten signatures, initials, etc. -must be available and subject to FDA inspection -may be in lieu of paper recor...
SOCRA CCRP Reporting & Timelines Correct 100%
A sponsor who determines and unanticipated AE presents unreasonable risk, termination shall occur within _____ working days and not later than ___ working days after sponsor first received notice of effect - ANSWER 5, 15 IRB determinations for emergency situations are to be retained by IRB for at least ___ years after completion of clinical investigation - ANSWER 3
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A sponsor who determines and unanticipated AE presents unreasonable risk, termination shall occur within _____ working days and not later than ___ working days after sponsor first received notice of effect - ANSWER 5, 15 IRB determinations for emergency situations are to be retained by IRB for at least ___ years after completion of clinical investigation - ANSWER 3
SOCRA CCRP Exam Correct Questions & Solutions
Timeline of Historical Events - ANSWER Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report - ANSWER respect for persons, beneficence, justice Application of Respect for Persons - ANSWER informed consent (autonomy, choose for themselves)
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Timeline of Historical Events - ANSWER Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report - ANSWER respect for persons, beneficence, justice Application of Respect for Persons - ANSWER informed consent (autonomy, choose for themselves)
SOCRA CCRP EXAM 2025 LATEST UPDATE
Which countries are included in the ICH GCP? - ANSWER European Union, Japan, United States, Canada and Switzerland What is the monitor not responsible for? A) Patient information B) Sponsor SOP C) Protocol/ICF D) Reporting to IRB - ANSWER According to ICH E6, an inspection is defined as: - ANSWER An official review of documents, facilities, records, and any other resources related to a clinical trial. An investigator shall submit a final report to the sponsor and the reviewing IRB...
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Which countries are included in the ICH GCP? - ANSWER European Union, Japan, United States, Canada and Switzerland What is the monitor not responsible for? A) Patient information B) Sponsor SOP C) Protocol/ICF D) Reporting to IRB - ANSWER According to ICH E6, an inspection is defined as: - ANSWER An official review of documents, facilities, records, and any other resources related to a clinical trial. An investigator shall submit a final report to the sponsor and the reviewing IRB...
SOCRA (CCRP) Exam Practice Questions & Answers(RATED A)
The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: - ANSWER Persons with diminished autonomy are entitled to protection. Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - ANSWER Determining that the study has a maximization of benefits and a minimization of risks
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The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: - ANSWER Persons with diminished autonomy are entitled to protection. Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - ANSWER Determining that the study has a maximization of benefits and a minimization of risks
SOCRA CCRP Exam Questions & Correct Answers(RATED A+)
April 30 1996 - ANSWER ICH GCP Development Date Quality - ANSWER ICH Q Efficacy - ANSWER ICH E Safety - ANSWER ICH S Multidisciplinary - ANSWER ICH M
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April 30 1996 - ANSWER ICH GCP Development Date Quality - ANSWER ICH Q Efficacy - ANSWER ICH E Safety - ANSWER ICH S Multidisciplinary - ANSWER ICH M
Home Health Aide Exam CORRECT QUESTIONS & ANSWERS(GRADED A)
NHA: CERTIFIED CLINICAL MEDICAL ASSISTANT PRACTICE EXAM 1 100% ACCURATE
TICO Supervisor/ Manager Exam Correct 100%
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