CURRENTLY TESTING
COMPLETE EXAM QUESTIONS WITH 100%
DETAILED ANSWERS VERIFIED AND GRADED
A+
What are the purposes of the 1572 form? - ANSWER--
Identify facilities involved in conducting the clinical trial
project
- Commitment by investigator for appropriate conduct of
the clinical trial
- Name and address of where the investigation will be held
,True and False? If a clinical trial required home visits, the
subjects address should be listed on 1572. - ANSWER-
False
True or False? If a resident is on rotation, and assessed
an AE, it's okay if they're NOT listed on 1572. - ANSWER-
True
True or False? The 1572 is considered a legally binding
contract between the PI and FDA. - ANSWER-False
Clinical trials assessing a medicinal products safety may
fall which phases? - ANSWER-Phase I, II, III, IV
,In which trial phases would the following trial design most
likely be found? An international double-blind randomized
trial comparing the efficacy of two doses of trial drug with a
commonly used competition in 50 sites recruitment of 10-
30 subjects each. - ANSWER-Phase III, IV
The drug 'Enhance' has been approved for marketing in
wound healing in adults. When it's on the market, the plan
is to explore using it in children in the future. Which
actions should be taken? - ANSWER-- A development
program for use in children should be written
- Experience with use in children so far should be
collected and used in the development plan
, - Conduct pharmacodynamic/pharmacokinetic studies in
children if theres no relevant information available from
similar compounds
What should be contained in study design? - ANSWER--
Appropriate comparators
- Adequate numbers of subjects
- Clear endpoints
You're a CRA looking for a site to conduct a phase II trial.
What should you be looking for to ensure the site is able to
conduct the trial successfully? - ANSWER-- Sufficient
resources to ensure patient safety