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SOCRA EXAMS BUNDLE| Questions with 100% Correct Answers
SOCRA EXAMS BUNDLE| Questions with 100% Correct Answers
[Show more]SOCRA EXAMS BUNDLE| Questions with 100% Correct Answers
[Show more]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, 
Ca...
Preview 2 out of 15 pages
Add to cartA 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, 
Ca...
Biometrics - ANSWER 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 - ANSWER An environment in...
Preview 3 out of 17 pages
Add to cartBiometrics - ANSWER 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 - ANSWER An environment in...
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...
Preview 2 out of 6 pages
Add to cartContract 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...
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: - AN...
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Add to cartWhich 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: - AN...
SOCRA EXAM 2024- with 100% Correct Answers ( A 
Graded) 
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, maintaine...
Preview 4 out of 50 pages
Add to cartSOCRA EXAM 2024- with 100% Correct Answers ( A 
Graded) 
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, maintaine...
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 bodies;...
Preview 3 out of 25 pages
Add to cartLaws - 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 bodies;...
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