Medication Management Oversight Flashcards
7 cards from real CRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Medication Management Oversight flashcards as text
A clinical site receives an investigational drug shipment that arrives at an incorrect temperature. According to GCP, the site should:
Answer: Quarantine the shipment, document the issue, and contact the sponsor before use
Shipments with temperature excursions must be quarantined and the sponsor notified to conduct a stability review before any drug is administered.
In a multicenter trial, which document defines the specific roles each staff member may perform related to investigational drug handling?
Answer: Delegation of authority log
The delegation of authority log specifies which qualified staff members are authorized to perform specific study tasks, including drug handling.
The FDA's 'right of access' under 21 CFR Part 312 means that FDA inspectors may review:
Answer: Any records related to the clinical investigation, including drug accountability logs
Under 21 CFR 312.58, FDA has the authority to inspect and copy all records related to a clinical investigation, including drug accountability records.
When a clinical trial participant returns unused blister packs of study drug, the site should:
Answer: Count, record returned quantities in the drug accountability log, and store or destroy per protocol
Returned study drug must be counted, documented in the accountability log, and handled (stored or destroyed) according to the protocol and sponsor instructions.
Which ICH E6(R2) GCP principle directly addresses the requirement for investigational products to be manufactured in accordance with applicable GMP?
Answer: Principle 8 — Investigational product quality and handling
ICH E6(R2) Principle 8 requires that investigational products be manufactured, handled, and stored per GMP and used per the approved protocol.
An IND-exempt study using an approved drug in a new dose combination no longer requires an IND if it meets all of the following conditions EXCEPT:
Answer: The study involves a new patient population never studied before
Studying a new (unstudied) patient population can increase risk and may require an IND; IND exemption generally requires no significant increase in risk.
A sponsor-investigator conducting a Phase I first-in-human study must ensure the investigational drug label includes:
Answer: Statement 'Caution: New Drug — Limited by Federal law to investigational use'
21 CFR 312.6 requires that investigational drug labels bear the statement limiting use to investigational purposes.