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[Show more]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 the fol...
Preview 3 out of 19 pages
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 the fol...
How does an assessment gather information? - through collection of data, observation, and 
physical examination 
What type of assessment? 
•Gather information about the patient from available sources such as medical records or reports 
from diagnostic studies 
• Perform direct measurements on th...
Preview 2 out of 7 pages
Add to cartHow does an assessment gather information? - through collection of data, observation, and 
physical examination 
What type of assessment? 
•Gather information about the patient from available sources such as medical records or reports 
from diagnostic studies 
• Perform direct measurements on th...
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? (7) - 
1. Ris...
Preview 4 out of 57 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? (7) - 
1. Ris...
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 
-Investigator's ...
Preview 2 out of 11 pages
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 
-Investigator's ...
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 
procee...
Preview 4 out of 59 pages
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 
procee...
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 a piece of ch...
Preview 2 out of 10 pages
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 a piece of ch...
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