ANSWERS (ALREADY GRADED A+); VERIFIED
ANSWERS; LATEST VERSION
1571 - correct answer- IND application; Permit to do research on
humans for the first time; has background info; and rationale; updated
annually
1572 - correct answer- Investigator statement; commitment, done
nationally and internationally by sponsors intending to hava marketing
aproval for IP
Cohort - correct answer- Subjects are matched for similar groups; ex:
Smokers, sex and age
GCP - correct answer- Standard for designing, conducting, and
reporting clinical trials; to make sure data is acurate, and to make sure
the rights, integrity and confidentiality of patient is protected.
IB - correct answer- Clinical and non-clinical data on the
investigational product that is relevant to the study in human subjects;
supplied prior to regulatory approval