The phase in early drug development that determines efficacy and dosing is?

Who on the research team agrees to promptly report adverse events that may be related to the study medication(s)?

Clinical Coding Workout Chapter 4, question 4.68 This is one of multiple hospital admissions for this 37-year-old white male with a history of meningoencephalitis 20 years ago. He developed obstructive hydrocephalus as a late effect/sequela and underwent ventriculoperitoneal shunting of the right lateral ventricle using a high-pressure valve. The patient is now complaining of numbness in his right leg, headaches, and diplopia. The patient had a low osmolar CT head scan which showed a slight increase in the hydrocephalus involving the fourth ventricle. Impression was shunt malfunction. He is admitted this time for VP shunt revision. An incision just behind the patient’s ear was made to access the valve which was noted to be obstructed. The valve and catheter present in the cerebral ventricle were replaced and reconnected to the existing catheter draining the fluid into the peritoneal cavity. The system was functioning well prior to closure. Which of the following is the correct code assignment? 

What is a clinical trial’s start-up commonly compared to?

What is the difference between an informed consent and a contract?

What are ghostwriters?

Devises such as endoscopes and EKG machines are included in which devise classification?

When discussing the risks and benefits of clinical trials with potential volunteers…

Your research experience summary should include all EXCEPT:

What is the time frame a sponsor has to report a nonfatal unexpected serious adverse event to the FDA?