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CRC Exam Questions with validated answers.
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CRC Exam Questions with validated answers.
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CRC Exam Questions with validatedanswers.
Indemnification ANS - The process to protect (indemnify) the study investigator against unintentional
loss, hurt, or damage. Essentially the sponsor protects the site.
CAPA ANS - Corrective and preventative action plan. Plan put in place to prevent further deviation
within a study when retraining does not work. Four steps of CAPA: identify problem, resulting action,
verification, and follow up.
FDA form 1572 ANS - Contract between Investigator and FDA, documenting the Investigator is
responsible for conducting the study following all FDA/USHHS regulations and keeping appropriate
records.
Surgical removal of uterus ANS - hysterectomy
Surgical removal of gallbladder ANS - cholecystectomy
Medical term for kidney stones ANS - nephrolithiasis
Action to take when patient has positive pregnancy test ANS - Report to sponsor and IRB, notify PI,
instruct pt to stop IP, follow up with pt and child
Lead placement: V1 ANS - 4th intercostal to the right of the sternium
Lead placement V2 ANS - 4th intercostal left of sternum
Lead placement V3 ANS - Midway between V2 and V4
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