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Socra CCRP Exam Prep Test 2024- with 100% Correct Answers ( A Graded
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Socra CCRP Exam Prep Test 2024- with 100% Correct Answers ( A Graded
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Socra CCRP Exam Prep Test 2024- with100% Correct Answers ( A Graded)
What date should an investigator write when he failed to sign the consent form on the date
of consent? - ANSWER date of investigators signature
for MEDICAL DEVICE trials the P.I. should submit to the sponosr & IRB a report of any
unanticapted adverse asap but no later than___ - ANSWER 10 days
assent - ANSWER means a child's affirmative agreement to participate in a clinical investigation.
consent from 1 or both parents or LAR is required.
IRB exemptions can be made If immediate use of the test article is, in the investigator's opinion,
required to preserve the life of the subject, and time is not sufficient to obtain the independent
determination use of the test article, must be submitted to the IRB and FDA in - ANSWER 5 days
control group design - ANSWER eliminates bias
double bllinded - ANSWER neither the subjects nor the experimenters know which subjects
are in the test and control groups
randomized double blilnded - ANSWER placebo-controlled trial of a medical treatment, some of
the participants are given the treatment, others are given fake treatment (placebo), and neither
the researchers nor the participants know which is which until the study ends
, single blinded - ANSWER only the participant does not know whether they are part of the
treatment or control group,
cross over design - ANSWER is a longitudinal study in which subjects receive a sequence of
different treatments (or exposures).
how long should essential clinical trial records be retained at site? - ANSWER 2 yrs after FDA
approval or 2 years after study ended
The records required by this policy shall be retained for at least _____and records relating to
research
which is conducted shall be retained for at least ___ years after completion of the research. -
ANSWER 3 years
changes in protocol - ANSWER A sponsor shall submit a protocol amendment describing any
change in a Phase 1 protocol that significantly affects the safety of subjects or any change in a
Phase 2 or 3 protocol that significantly affects the safety of subjects, the scope of the
investigation, or the scientific quality of the study.
class I - ANSWER General controls bandages, gloves, tongue depressors
Class II - ANSWER general control+special controls (x-ray machines, monitors)
Class III - ANSWER general controls+ premarket approval (pacemaker, diagnostic test,
silicone gel breast implant)
sponsor must discontinue the use of any investigational product that causes unreasonable risk
to subjects and notify the FDA in - ANSWER 5 days
sponsor must submit saftey report in ___after knowing of an event that meet reporting
criteria - ANSWER 15 days
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