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RGA 6210 – Homework Assignment 4

Due to the complexity of this Week 4 homework assignment, it is worth 50 points!
Name:
1. Animal Strategy (1 point)
Based on the simulated meeting for forming an animal strategy in this week’s
Lecture 4 slides where you provided five important advice to the Clinical
Research team, they did not trust you as they thought you were being too
conservative about how the animal testing should be conducted under GLP
conditions. They think you are making this up and they are upset because they
have to spend $20,000 USD more and the animal testing will take 2-3 months
longer than that of a non-GLP animal study.
Instead of ignoring them or asking them to see your RA manager for further
discussion, you have the option to nicely and gently guide them to FDA’s Code of
Federal Regulations (CFR) for GLP testing.
Hint – similarly to your Week 4 reading assignment, go to www.fda.gov and click
on “Medical Devices” and click on “Device Advice” and in the search box, type
“Good Laboratory Practices.”
What is the 21 CFR “XX” code for GLP testing?
2
2. Clinical Strategy (5 points)
Based on the simulated meeting for forming a human clinical strategy in this
week’s Lecture 4 slides where you also provided five important advice to the
Clinical Research team, they have now earned your trust and respect you wholeheartedly
as an experienced RA professional.
They need your guidance for forming the inclusion and exclusion criteria for this
Atrial Fibrillation clinical study because they have no idea until they can get a
hold of another competitors’ clinical study protocol.
They also don’t know if FDA would accept a 3 month follow up on the patients
for a primary effectiveness endpoint. They also don’t know if FDA requires a
secondary long-term follow-up on the enrolled patients.
Hint – similarly to your Week 4 reading assignment, go to www.fda.gov and click
on “Medical Devices” and click on “Device Advice” and click on “Guidance
Documents” and in the search box, type “Catheter Ablation Atrial Fibrillation”
(please watch out and do not use the FDA guidance on using surgical ablation
devices to treat AFib).
a. Per recommendations from FDA when designing an AFib clinical study,
provide at least 2 inclusion criteria and 1 exclusion criteria for patient
selection.