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CCRP SOCRA | CCRP EXAM PACK GRADED A+
CCRP SOCRA | CCRP EXAM PACK GRADED A+
[Show more]CCRP SOCRA | CCRP EXAM PACK GRADED A+
[Show more]CCRP Exam Graded A+ 
How many days does a sponsor have to report an emergency use of an IP to the 
FDA? - ANS5 working days 
How many members must sit on an IRB? - ANS5 
How long must an IRB retain records per 21 CFR 56? - ANS3 years after 
completion of research 
What are the criteria for IRB appro...
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How many days does a sponsor have to report an emergency use of an IP to the 
FDA? - ANS5 working days 
How many members must sit on an IRB? - ANS5 
How long must an IRB retain records per 21 CFR 56? - ANS3 years after 
completion of research 
What are the criteria for IRB appro...
CCRP Exam Graded A+ 
21 CFR 11 - ANSElectronic Records; Electronic Signatures 
B - Electronic Records 
C - Electronic Signatures 
21 CFR 50 - ANSProtection of Human Subjects/Informed Consent 
B - Informed Consent 
50.23 - Exception from General 
50.24 - Exception from Informed Consent Requirements f...
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21 CFR 11 - ANSElectronic Records; Electronic Signatures 
B - Electronic Records 
C - Electronic Signatures 
21 CFR 50 - ANSProtection of Human Subjects/Informed Consent 
B - Informed Consent 
50.23 - Exception from General 
50.24 - Exception from Informed Consent Requirements f...
CCRP EXAM WITH VERIFIED 
QUESTIONS AND ANSWERS 
How many days does a sponsor have to report an emergency use of an IP to the 
FDA? - ANS5 working days 
How many members must sit on an IRB? - ANS5 
How long must an IRB retain records per 21 CFR 56? - ANS3 years after 
completion of research 
What are...
Preview 4 out of 41 pages
Add to cartCCRP EXAM WITH VERIFIED 
QUESTIONS AND ANSWERS 
How many days does a sponsor have to report an emergency use of an IP to the 
FDA? - ANS5 working days 
How many members must sit on an IRB? - ANS5 
How long must an IRB retain records per 21 CFR 56? - ANS3 years after 
completion of research 
What are...
CCRP SOCRA Exam Graded A+ 
FDA Part 11 - ANSelectronic signatures are of the same validity as handwritten 
signatures, must provide 2 identifiers and verify identification of signer 
FDA Part 50 - ANSFood and Drugs, and ICF 
FDA Part 56 - ANSIRBs 
FDA Part 312 - ANSinvestigational new drug applicati...
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FDA Part 11 - ANSelectronic signatures are of the same validity as handwritten 
signatures, must provide 2 identifiers and verify identification of signer 
FDA Part 50 - ANSFood and Drugs, and ICF 
FDA Part 56 - ANSIRBs 
FDA Part 312 - ANSinvestigational new drug applicati...
CCRP SOCRA Exam Graded A+ 
Contract Research Organization - ANSA 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...
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Contract Research Organization - ANSA 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...
CCRP SOCRA Exam Graded A+ 
April 30 1996 - ANSICH GCP Development Date 
Quality - ANSICH Q 
Efficacy - ANSICH E 
Safety - ANSICH S 
Multidisciplinary - ANSICH M 
guidance for industry, consolidated guideance - ANSICH E 6 
Clinical Safety Data Management Definitions and Standards - ANSICH E2A 
Safety...
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April 30 1996 - ANSICH GCP Development Date 
Quality - ANSICH Q 
Efficacy - ANSICH E 
Safety - ANSICH S 
Multidisciplinary - ANSICH M 
guidance for industry, consolidated guideance - ANSICH E 6 
Clinical Safety Data Management Definitions and Standards - ANSICH E2A 
Safety...
CCRP SOCRA Exam Graded A+ 
When was the Nuremberg Code created? - ANS1947 
What did the Nuremberg Code establish? - ANSWorldwide requirement for 
informed consent with properly formulated experimentation with beneficence 
towards participants. 
When was Belmont report established? - ANS1979 
What do...
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When was the Nuremberg Code created? - ANS1947 
What did the Nuremberg Code establish? - ANSWorldwide requirement for 
informed consent with properly formulated experimentation with beneficence 
towards participants. 
When was Belmont report established? - ANS1979 
What do...
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