1571 - ANSWER IND application; Permit to do research on humans for the first time; has background info; and rationale; updated annually
1572 - ANSWER Investigator statement; commitment, done nationally and internationally by sponsors intending to hava marketing aproval for IP
Study Type - Place...
ACRP CP Exam QUESTIONS & ANSWERS
1571 - ANSWER IND application; Permit to do research on humans for the first time; has background
info; and rationale; updated annually
1572 - ANSWER Investigator statement; commitment, done nationally and internationally by sponsors
intending to hava marketing aproval for IP
Study Type - Placebo control - ANSWER in addition to a group of subjects that receives the treatment to
be evaluated, a separate control group receives a placebo
Study Type - Active control - ANSWER Done when use of placebo is unethical like antibiotics studies.
Means that a known, effective treatment (as opposed to a placebo) is compared to an experimental
treatment
Randomization - ANSWER method used to equify distribution of Tx to subjects; to eliminate bias
Stratification - ANSWER method used to control assignment based on variables; like disease status;
ALLOWS BALANCED COMPARABILITY
PK studies - ANSWER Involves taking several blood samples over a period of time to determine how the
body handles the substance
IDE - ANSWER Investigational device exemption; to administer an investigational drug or biological
product to humans
GCP - 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.
ICH GCP Requirements before accepting a protocol - ANSWER - Potential to recruit proper number of
patients
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