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CCRP |SOCRA| AACVPR Exam Questions with Correct Solutions Exam Bundle
CCRP |SOCRA| AACVPR Exam Questions with Correct Solutions Exam Bundle
[Show more]CCRP |SOCRA| AACVPR Exam Questions with Correct Solutions Exam Bundle
[Show more]How many days does a sponsor have to report an emergency use of an IP to the FDA? - 5 working days 
 
How many members must sit on an IRB? - 5 
 
How long must an IRB retain records per 21 CFR 56? - 3 years after completion of research 
 
What are the criteria for IRB approval of research? ...
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Add to cartHow many days does a sponsor have to report an emergency use of an IP to the FDA? - 5 working days 
 
How many members must sit on an IRB? - 5 
 
How long must an IRB retain records per 21 CFR 56? - 3 years after completion of research 
 
What are the criteria for IRB approval of research? ...
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 
-Investigato...
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Add to cartWhen 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 
-Investigato...
Who was tried in the Nuremburg Military Tribunals and why? - Doctors who committed war crimes against humanity including medical experiments on concentration camp inmates and other human subjects without consent 
 
What was the outcome of the Nuremburg Military Tribunals? - After 140 days of p...
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Add to cartWho was tried in the Nuremburg Military Tribunals and why? - Doctors who committed war crimes against humanity including medical experiments on concentration camp inmates and other human subjects without consent 
 
What was the outcome of the Nuremburg Military Tribunals? - After 140 days of p...
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 s...
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Add to cartBiometrics - 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 s...
How many days does a sponsor have to report an emergency use of an IP to the FDA? - 5 working days 
 
How many members must sit on an IRB? - 5 
 
How long must an IRB retain records per 21 CFR 56? - 3 years after completion of research 
 
What are the criteria for IRB approval of research? ...
Preview 4 out of 35 pages
Add to cartHow many days does a sponsor have to report an emergency use of an IP to the FDA? - 5 working days 
 
How many members must sit on an IRB? - 5 
 
How long must an IRB retain records per 21 CFR 56? - 3 years after completion of research 
 
What are the criteria for IRB approval of research? ...
SAE - Serious Adverse Event: 
- results in death 
- is life threatening (patient was at risk of death at time of the event) 
- results in persistent or significant disability 
- congenital anomaly/birth defect 
 
Short Form - A document that states that the elements of informed consent have be...
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Add to cartSAE - Serious Adverse Event: 
- results in death 
- is life threatening (patient was at risk of death at time of the event) 
- results in persistent or significant disability 
- congenital anomaly/birth defect 
 
Short Form - A document that states that the elements of informed consent have be...
21 CFR 11 - Electronic Records; Electronic Signatures 
 
B - Electronic Records 
C - Electronic Signatures 
 
21 CFR 50 - Protection of Human Subjects/Informed Consent 
 
B - Informed Consent 
50.23 - Exception from General 
50.24 - Exception from Informed Consent Requirements for Emergency Re...
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Add to cart21 CFR 11 - Electronic Records; Electronic Signatures 
 
B - Electronic Records 
C - Electronic Signatures 
 
21 CFR 50 - Protection of Human Subjects/Informed Consent 
 
B - Informed Consent 
50.23 - Exception from General 
50.24 - Exception from Informed Consent Requirements for Emergency Re...
What influences a persons metabolic rate? - Exercise, gender, genetics, age 
 
Which is the macronutrient that provides more than twice as many calories as the other two - Fat 
 
Foods that raise insulin levels have... - added sugar 
 
When feeling stressed, you may feel relief after eating...
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Add to cartWhat influences a persons metabolic rate? - Exercise, gender, genetics, age 
 
Which is the macronutrient that provides more than twice as many calories as the other two - Fat 
 
Foods that raise insulin levels have... - added sugar 
 
When feeling stressed, you may feel relief after eating...
Year/ description of the Nuremberg Code - 1947- German physicians conducted unethical experiments on concentration camp prisoners without their consent. 
 
What implications came of the Nuremberg Code? - Ten elements of human research including voluntary informed consent is absolutely essentia...
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Add to cartYear/ description of the Nuremberg Code - 1947- German physicians conducted unethical experiments on concentration camp prisoners without their consent. 
 
What implications came of the Nuremberg Code? - Ten elements of human research including voluntary informed consent is absolutely essentia...
Nuremburg Code - The first set of principles outlining professional ethics for clinical research. 
 
Nuremburg Code elements - 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 disabl...
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Add to cartNuremburg Code - The first set of principles outlining professional ethics for clinical research. 
 
Nuremburg Code elements - 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 disabl...
April 30 1996 - ICH GCP Development Date 
 
Quality - ICH Q 
 
Efficacy - ICH E 
 
Safety - ICH S 
 
Multidisciplinary - ICH M 
 
guidance for industry, consolidated guideance - ICH E 6 
 
Clinical Safety Data Management Definitions and Standards - ICH E2A 
 
Safety pharmacology...
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Add to cartApril 30 1996 - ICH GCP Development Date 
 
Quality - ICH Q 
 
Efficacy - ICH E 
 
Safety - ICH S 
 
Multidisciplinary - ICH M 
 
guidance for industry, consolidated guideance - ICH E 6 
 
Clinical Safety Data Management Definitions and Standards - ICH E2A 
 
Safety pharmacology...
21 CFR Part 11 
Electronic Records; Electronic Signatures 
 
 
21 CFR Part 11 Subpart B 
Electronic Records 
 
 
21 CFR Part 11 Subpart C 
Electronic Signatures 
 
 
21 CFR Part 50 
Protection of Human Subjects 
 
 
21 CFR Part 50 Subpart B 
Informed Consent of Human Subjects 
 
 
21 CFR Part 50 Sub...
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Add to cart21 CFR Part 11 
Electronic Records; Electronic Signatures 
 
 
21 CFR Part 11 Subpart B 
Electronic Records 
 
 
21 CFR Part 11 Subpart C 
Electronic Signatures 
 
 
21 CFR Part 50 
Protection of Human Subjects 
 
 
21 CFR Part 50 Subpart B 
Informed Consent of Human Subjects 
 
 
21 CFR Part 50 Sub...
CFR Title 21: Part 11 - Electronic Records; Electronic Signatures 
 
Part 11, Subpart A: General Provisions - -must be trustworthy, reliable, and generally equivalent to paper records 
-applies to electronic forms that are created, modified, maintained, archived, retrieved, or transmitted 
-wh...
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Add to cartCFR Title 21: Part 11 - Electronic Records; Electronic Signatures 
 
Part 11, Subpart A: General Provisions - -must be trustworthy, reliable, and generally equivalent to paper records 
-applies to electronic forms that are created, modified, maintained, archived, retrieved, or transmitted 
-wh...
5 
The minimum number of IRB members 
 
 
Subjects cannot be enrolled until IRB/IEC approval has been obtained 
In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? 
 
 
 
The Sponsor 
The responsibility for e...
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The minimum number of IRB members 
 
 
Subjects cannot be enrolled until IRB/IEC approval has been obtained 
In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? 
 
 
 
The Sponsor 
The responsibility for e...
Contract Research Organization - 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 summary...
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Add to cartContract Research Organization - 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 summary...
Nuremberg Code (1947) - 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 - 1. voluntary 
2. necessary for results 
3. logical design and results 
4. a...
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Add to cartNuremberg Code (1947) - 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 - 1. voluntary 
2. necessary for results 
3. logical design and results 
4. a...
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 
...
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Add to cartElectronic 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 
...
Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the: - PI and Sponsor. 
 
In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? - The subject's legally acceptable representative 
 
Which of...
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Add to cartPrior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the: - PI and Sponsor. 
 
In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? - The subject's legally acceptable representative 
 
Which of...
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 ...
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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 
 
If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - FDA ...
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 ...
Preview 2 out of 11 pages
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 
 
If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - FDA ...
Shoulder Flexion Normal ROM - 30-60 
 
Shoulder Extension Normal ROM - 160-170 
 
Shoulder Abduction Normal ROM - 40-50 
 
Shoulder Adduction Normal ROM - 40-50 
 
Shoulder Internal Rotation Normal ROM - 40-50 
 
Shoulder External Rotation Normal ROM - 40-50 
 
Elbow Flexion Normal...
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Add to cartShoulder Flexion Normal ROM - 30-60 
 
Shoulder Extension Normal ROM - 160-170 
 
Shoulder Abduction Normal ROM - 40-50 
 
Shoulder Adduction Normal ROM - 40-50 
 
Shoulder Internal Rotation Normal ROM - 40-50 
 
Shoulder External Rotation Normal ROM - 40-50 
 
Elbow Flexion Normal...
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) 
 
Appl...
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Add to cartTimeline 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) 
 
Appl...
The ICH is concerned with harmonization of technical requirements for registration of pharmaceutical products from what three regions? - European Union, Japan and United States 
 
What organizations are represented in the ICH Steering Committee? - Australia, Canada, the Nordic countries and th...
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Add to cartThe ICH is concerned with harmonization of technical requirements for registration of pharmaceutical products from what three regions? - European Union, Japan and United States 
 
What organizations are represented in the ICH Steering Committee? - Australia, Canada, the Nordic countries and th...
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 s...
Preview 2 out of 14 pages
Add to cartBiometrics - 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 s...
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