Lote
SOCRA CCRP Exam Bundle Questions And Answers 100% Verified
SOCRA CCRP Exam Bundle Questions And Answers 100% Verified
[Mostrar más]SOCRA CCRP Exam Bundle Questions And Answers 100% Verified
[Mostrar más]A patient received an initial dose and had no initial reaction. The protocol says the patient needs to increase it by 20%. The initial dose was 370mg^3/m; what is the next treatment? - ANSWER-444mg^3/m 
 
Which countries are included in the ICH GCP? - ANSWER-European Union, Japan, United States, Can...
Vista previa 2 fuera de 15 páginas
Añadir al carritoA patient received an initial dose and had no initial reaction. The protocol says the patient needs to increase it by 20%. The initial dose was 370mg^3/m; what is the next treatment? - ANSWER-444mg^3/m 
 
Which countries are included in the ICH GCP? - ANSWER-European Union, Japan, United States, Can...
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...
Vista previa 3 fuera de 21 páginas
Añadir al carritoDoes 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...
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...
Vista previa 2 fuera de 6 páginas
Añadir al carritoElectronic 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...
Contract Research Organization - ANSWER-A person or an organization (commercial, academic, or other) contracted by the sponsor to 
perform one or more of a sponsor's trial-related duties and functions. 
 
When a short form is used for informed consent the witness must sign the short form or the sum...
Vista previa 2 fuera de 6 páginas
Añadir al carritoContract Research Organization - ANSWER-A person or an organization (commercial, academic, or other) contracted by the sponsor to 
perform one or more of a sponsor's trial-related duties and functions. 
 
When a short form is used for informed consent the witness must sign the short form or the sum...
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...
Vista previa 4 fuera de 48 páginas
Añadir al carritoElectronic 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...
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...
Vista previa 1 fuera de 2 páginas
Añadir al carritoThe 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 Purpose of the IRB is to: - ANSWER-Protect the rights and welfare of human subjects in research 
 
What is the minimum number of members required by an IRB - ANSWER-5 
 
Which of the following are necessary to waive consent? 
 
A.Subject is unable to give consent 
B.No time or unable to contact ...
Vista previa 3 fuera de 19 páginas
Añadir al carritoThe Purpose of the IRB is to: - ANSWER-Protect the rights and welfare of human subjects in research 
 
What is the minimum number of members required by an IRB - ANSWER-5 
 
Which of the following are necessary to waive consent? 
 
A.Subject is unable to give consent 
B.No time or unable to contact ...
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 
-...
Vista previa 3 fuera de 26 páginas
Añadir al carritoWhen 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 
-...
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...
Vista previa 3 fuera de 24 páginas
Añadir al carritoApril 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...
Belmont Report was created as part of? - ANSWER-The national Research Act of 1974. 
 
Who was the Belmont Report formulated by? - ANSWER-The National Commission for the protection of human subjects in biomedical and behavioral research. 
 
What year was the publication of the FDA regulations made? -...
Vista previa 4 fuera de 36 páginas
Añadir al carritoBelmont Report was created as part of? - ANSWER-The national Research Act of 1974. 
 
Who was the Belmont Report formulated by? - ANSWER-The National Commission for the protection of human subjects in biomedical and behavioral research. 
 
What year was the publication of the FDA regulations made? -...
The ICH is concerned with harmonization of technical requirements for registration of pharmaceutical products from what three regions? 
A. European Union, US and Canada 
B. Mexico, European Union and US 
C. US, Russia and European Union 
D. European Union, Japan and US - ANSWER-D. European Union, Ja...
Vista previa 4 fuera de 45 páginas
Añadir al carritoThe ICH is concerned with harmonization of technical requirements for registration of pharmaceutical products from what three regions? 
A. European Union, US and Canada 
B. Mexico, European Union and US 
C. US, Russia and European Union 
D. European Union, Japan and US - ANSWER-D. European Union, Ja...
1. Study invoves research (why and how) 
2. Forseeable risks 
3. Potential benefits 
4. Alternatives 
5. Confidentiality 
6. Compensation 
7. Contacts for answers 
8. Voluntary nature - ANSWER-What are the 8 basic elements of an informed consent that are REQUIRED to be discussed and in the form? 
 
...
Vista previa 1 fuera de 2 páginas
Añadir al carrito1. Study invoves research (why and how) 
2. Forseeable risks 
3. Potential benefits 
4. Alternatives 
5. Confidentiality 
6. Compensation 
7. Contacts for answers 
8. Voluntary nature - ANSWER-What are the 8 basic elements of an informed consent that are REQUIRED to be discussed and in the form? 
 
...
CRO- transfer of responsibility - ANSWER-Sponsor may transfer responsibility for any or all obligations to a contract research organization. It just needs to be in writing. 21 CFR 312 
 
1572 Form - ANSWER-Commitment of the investigator to sponsor to follow all regulations. 
 
Investigator Brochure ...
Vista previa 2 fuera de 5 páginas
Añadir al carritoCRO- transfer of responsibility - ANSWER-Sponsor may transfer responsibility for any or all obligations to a contract research organization. It just needs to be in writing. 21 CFR 312 
 
1572 Form - ANSWER-Commitment of the investigator to sponsor to follow all regulations. 
 
Investigator Brochure ...
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 themsel...
Vista previa 2 fuera de 8 páginas
Añadir al carritoTimeline 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 themsel...
The ICH is concerned with harmonization of technical requirements for registration of pharmaceutical products from what three regions? - ANSWER-European Union, Japan and United States 
 
What organizations are represented in the ICH Steering Committee? - ANSWER-Australia, Canada, the Nordic countrie...
Vista previa 2 fuera de 7 páginas
Añadir al carritoThe ICH is concerned with harmonization of technical requirements for registration of pharmaceutical products from what three regions? - ANSWER-European Union, Japan and United States 
 
What organizations are represented in the ICH Steering Committee? - ANSWER-Australia, Canada, the Nordic countrie...
Nuremberg Code (1947) - ANSWER-A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. 
 
The Nuremberg Code - 10 points - ANSWER-1. voluntary 
2. necessary for results 
3. logical design and resul...
Vista previa 4 fuera de 44 páginas
Añadir al carritoNuremberg Code (1947) - ANSWER-A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. 
 
The Nuremberg Code - 10 points - ANSWER-1. voluntary 
2. necessary for results 
3. logical design and resul...
Declaration of Helsinki - ANSWER-Ethical principles for medical research involving human subjects. Trials conducted under Good Clinical Practice generally follow the Declaration of Helsinki. 
 
3 Principles Belmont Report - ANSWER-respect for persons (informed consent) 
beneficence (assess risks and...
Vista previa 2 fuera de 11 páginas
Añadir al carritoDeclaration of Helsinki - ANSWER-Ethical principles for medical research involving human subjects. Trials conducted under Good Clinical Practice generally follow the Declaration of Helsinki. 
 
3 Principles Belmont Report - ANSWER-respect for persons (informed consent) 
beneficence (assess risks and...
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...
Vista previa 3 fuera de 23 páginas
Añadir al carritoLaws - 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...
Electronic Records - ANSWER-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
Vista previa 4 fuera de 63 páginas
Añadir al carritoElectronic Records - ANSWER-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
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...
Vista previa 1 fuera de 4 páginas
Añadir al carritoA 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...
ACT - ANSWER-Federal food drug and cosmetic acts 
 
agency - ANSWER-Food and Drug Administration 
 
Biometrics - ANSWER-Method of verifying ID based on measurement of physical features, repeatable features, where those features and/or actions are both unique to that individual and measurable 
 
clos...
Vista previa 1 fuera de 3 páginas
Añadir al carritoACT - ANSWER-Federal food drug and cosmetic acts 
 
agency - ANSWER-Food and Drug Administration 
 
Biometrics - ANSWER-Method of verifying ID based on measurement of physical features, repeatable features, where those features and/or actions are both unique to that individual and measurable 
 
clos...
What is an orphan drug program? - ANSWER-FDA program that provides development of drugs for rare diseases 
 
Nuremburg Code - ANSWER-set of standards proclaimed following the trial of Nazi doctors in 1947 
 
Kefauver-Harris Amendment - ANSWER-Amendment to Food Drug and Cosmetic Act that requires inf...
Vista previa 2 fuera de 5 páginas
Añadir al carritoWhat is an orphan drug program? - ANSWER-FDA program that provides development of drugs for rare diseases 
 
Nuremburg Code - ANSWER-set of standards proclaimed following the trial of Nazi doctors in 1947 
 
Kefauver-Harris Amendment - ANSWER-Amendment to Food Drug and Cosmetic Act that requires inf...
A subject has been enrolled on a study and was randomized to the non-treatment arm. The protocol outlines study procedures for all subjects to be performed within one week of enrollment. Which of the following statements about this case is correct? 
a. This subject does not need to undergo any of th...
Vista previa 1 fuera de 2 páginas
Añadir al carritoA subject has been enrolled on a study and was randomized to the non-treatment arm. The protocol outlines study procedures for all subjects to be performed within one week of enrollment. Which of the following statements about this case is correct? 
a. This subject does not need to undergo any of th...
When was the Nuremberg Code created? - ANSWER-1947 
 
What did the Nuremberg Code establish? - ANSWER-Worldwide requirement for informed consent with properly formulated experimentation with beneficence towards participants. 
 
When was Belmont report established? - ANSWER-1979 
 
What does the Belm...
Vista previa 2 fuera de 7 páginas
Añadir al carritoWhen was the Nuremberg Code created? - ANSWER-1947 
 
What did the Nuremberg Code establish? - ANSWER-Worldwide requirement for informed consent with properly formulated experimentation with beneficence towards participants. 
 
When was Belmont report established? - ANSWER-1979 
 
What does the Belm...
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: -...
Vista previa 2 fuera de 13 páginas
Añadir al carritoWhich 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: -...
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...
Vista previa 3 fuera de 23 páginas
Añadir al carritoLaws - 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...
Compradores de Stuvia evaluaron más de 700.000 resúmenes. Así estas seguro que compras los mejores documentos!
Puedes pagar rápidamente y en una vez con iDeal, tarjeta de crédito o con tu crédito de Stuvia. Sin tener que hacerte miembro.
Tus compañeros escriben los resúmenes. Por eso tienes la seguridad que tienes un resumen actual y confiable. Así llegas a la conclusión rapidamente!
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Nuestra garantía de satisfacción le asegura que siempre encontrará un documento de estudio a tu medida. Tu rellenas un formulario y nuestro equipo de atención al cliente se encarga del resto.
Stuvia is a marketplace, so you are not buying this document from us, but from seller remojudytask. Stuvia facilitates payment to the seller.
No, you only buy this summary for 21,90 €. You're not tied to anything after your purchase.
4.6 stars on Google & Trustpilot (+1000 reviews)
45,681 summaries were sold in the last 30 days
Founded in 2010, the go-to place to buy summaries for 14 years now