Investigational Product Management Flashcards
7 cards from real SOCRA CCRP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Investigational Product Management flashcards as text
What information is REQUIRED on the label of an investigational product intended for use in a clinical trial?
Answer: A statement that it is for investigational use only, protocol identification, and storage conditions
GCP and regulatory requirements mandate that IP labels include 'For Investigational Use Only,' protocol identification, and required storage conditions.
In a double-blind, randomized controlled trial, who typically holds the randomization code to protect blinding integrity?
Answer: An unblinded third party such as the sponsor's statistician or an unblinded pharmacist
In double-blind trials, the randomization code is maintained by an unblinded third party so no one at the site can determine treatment assignment.
Under what circumstance is emergency unblinding of a subject's treatment assignment justified in a blinded clinical trial?
Answer: When knowledge of treatment is essential for the subject's medical management in a life-threatening emergency
Emergency unblinding is only justified when the investigator needs the treatment assignment to provide appropriate emergency medical care to the subject.
A subject accidentally takes double their prescribed dose of investigational product. What must the site do?
Answer: Document the error as a protocol deviation, assess for adverse effects, and report per protocol
Medication errors must be documented as protocol deviations, the subject assessed for adverse effects, and events reported per protocol and regulatory requirements.
Which GCP principle requires that investigational products be used only for purposes specified in the study protocol?
Answer: The principle of investigational product accountability and control
GCP requires strict accountability and control of IP to ensure it is administered only as specified in the approved study protocol.
A sponsor requests that a site destroy excess investigational product on-site. What documentation is required?
Answer: A written destruction certificate signed by site personnel and witnessed
On-site IP destruction requires a written destruction certificate documenting the quantity destroyed, date, method, personnel involved, and a witness signature.
Which of the following is an IP accountability discrepancy that MUST be investigated at a clinical site?
Answer: A subject returning fewer unused tablets than expected based on dispensing records
Any discrepancy between the quantity of IP dispensed and the quantity returned or administered indicates an accountability problem requiring investigation.