Investigational Product, Device, and Specimen Accountability
D07The two competencies
C13 Maintain or evaluate custody and accountability.What this looks like on a Tuesday
Every bottle in, out and returned has a line in the log, and the count matches the shelf.
C14 Recognize and respond to accountability exceptions.What this looks like on a Tuesday
The fridge alarm went off overnight. You quarantine the kits and call before anyone dispenses.
Where it weighs most
- RP-CRN Clinical Research Nurse · Inside The Clinic
Questions in Ask the city
- A coordinator just resigned mid-study. What are the first three things you do?
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- What do you say to a patient who asks 'would you do this trial?'
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- Where is FDA's current informed consent guidance for a consent process question?
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- My PI asked what FDA actually expects of her. Which document do I send?
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- First week as a CRC. What should I do before anyone tells me to?
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