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[Show more]SOCRA CCRP Exam 2023 
 
 
April 30 1996 
Quality 
Efficacy 
Safety 
Multidisciplinary 
guidance for industry, consolidated guideance 
Clinical Safety Data Management Definitions and Standards 
Safety pharmacology studies for human pharmaceuticals 
 
Electronic records, electronic signatures ...
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Add to cartSOCRA CCRP Exam 2023 
 
 
April 30 1996 
Quality 
Efficacy 
Safety 
Multidisciplinary 
guidance for industry, consolidated guideance 
Clinical Safety Data Management Definitions and Standards 
Safety pharmacology studies for human pharmaceuticals 
 
Electronic records, electronic signatures ...
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. avoid...
Preview 4 out of 43 pages
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. avoid...
CCRP Exam questions & answers 
 
 
How many days does a sponsor have to report an emergency use of an IP to the FDA? - ANSWER-5 working days 
 
How many members must sit on an IRB? - ANSWER-5 
 
How long must an IRB retain records per 21 CFR 56? - ANSWER-3 years after completion of research 
 
What ...
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Add to cartCCRP Exam questions & answers 
 
 
How many days does a sponsor have to report an emergency use of an IP to the FDA? - ANSWER-5 working days 
 
How many members must sit on an IRB? - ANSWER-5 
 
How long must an IRB retain records per 21 CFR 56? - ANSWER-3 years after completion of research 
 
What ...
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Which of the following required elements should be included in a clinical trial protocol?
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Add to cartWhich of the following required elements should be included in a clinical trial protocol?
CCRP Practice Questions 
 
 
Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the: - ANSWER-PI and Sponsor. 
 
In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? - ANSWER-The subject's legally ...
Preview 2 out of 13 pages
Add to cartCCRP Practice Questions 
 
 
Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the: - ANSWER-PI and Sponsor. 
 
In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? - ANSWER-The subject's legally ...
CCRP Exam questions & answers 2023 
 
 
How many days does a sponsor have to report an emergency use of an IP to the FDA? - ANSWER-5 working days 
 
How many members must sit on an IRB? - ANSWER-5 
 
How long must an IRB retain records per 21 CFR 56? - ANSWER-3 years after completion of research 
 
...
Preview 4 out of 42 pages
Add to cartCCRP Exam questions & answers 2023 
 
 
How many days does a sponsor have to report an emergency use of an IP to the FDA? - ANSWER-5 working days 
 
How many members must sit on an IRB? - ANSWER-5 
 
How long must an IRB retain records per 21 CFR 56? - ANSWER-3 years after completion of research 
 
...
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 ...
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Add to cartCertified 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 ...
SOCRA CCRP Exam questions & answers 2023 
 
 
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 Ma...
Preview 3 out of 23 pages
Add to cartSOCRA CCRP Exam questions & answers 2023 
 
 
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 Ma...
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CCRP AACVPR questions & answers 2023 
 
 
What influences a persons metabolic rate? - ANSWER-Exercise, gender, genetics, age 
 
Which is the macronutrient that provides more than twice as many calories as the other two - ANSWER-Fat 
 
Foods that raise insulin levels have... - ANSWER-added sugar 
 
W...
Preview 2 out of 7 pages
Add to cartCCRP AACVPR questions & answers 2023 
 
 
What influences a persons metabolic rate? - ANSWER-Exercise, gender, genetics, age 
 
Which is the macronutrient that provides more than twice as many calories as the other two - ANSWER-Fat 
 
Foods that raise insulin levels have... - ANSWER-added sugar 
 
W...
SOCRA - CCRP (high level) 2023 
 
 
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 ...
Preview 4 out of 43 pages
Add to cartSOCRA - CCRP (high level) 2023 
 
 
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 ...
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