SOCRA CCRP Investigational Product Management 2 — Questions and Answers
Question 1: What information is REQUIRED on the label of an investigational product intended for use in a clinical trial?
- The commercial brand name and standard dosing instructions
- A statement that it is for investigational use only, protocol identification, and storage conditions (Correct answer)
- The subject's home address and insurance information
- The investigator's personal contact number
Correct 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.
Question 2: In a double-blind, randomized controlled trial, who typically holds the randomization code to protect blinding integrity?
- The principal investigator
- The subject's primary care physician
- An unblinded third party such as the sponsor's statistician or an unblinded pharmacist (Correct answer)
- The clinical research coordinator
Correct 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.
Question 3: Under what circumstance is emergency unblinding of a subject's treatment assignment justified in a blinded clinical trial?
- When the sponsor's monitor requests it for data clarification
- When the subject insists on knowing their treatment assignment
- When knowledge of treatment is essential for the subject's medical management in a life-threatening emergency (Correct answer)
- When the IRB requests it during a routine audit
Correct 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.
Question 4: A subject accidentally takes double their prescribed dose of investigational product. What must the site do?
- Report this only in the final clinical study report
- Document the error as a protocol deviation, assess for adverse effects, and report per protocol (Correct answer)
- Disregard the event if no symptoms are observed
- Immediately withdraw the subject without documentation
Correct 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.
Question 5: Which GCP principle requires that investigational products be used only for purposes specified in the study protocol?
- The principle of risk minimization
- The principle of investigational product accountability and control (Correct answer)
- The principle of scientific validity
- The principle of voluntary participation
Correct 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.
Question 6: A sponsor requests that a site destroy excess investigational product on-site. What documentation is required?
- A verbal confirmation from the site pharmacist is sufficient
- A written destruction certificate signed by site personnel and witnessed (Correct answer)
- An email notification to the IRB
- A separate IND amendment filed with FDA
Correct 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.
Question 7: Which of the following is an IP accountability discrepancy that MUST be investigated at a clinical site?
- A subject returning fewer unused tablets than expected based on dispensing records (Correct answer)
- A slight variation in tablet appearance between manufacturing lots
- IP arriving one day later than the scheduled shipment date
- A change in the investigational drug's commercial manufacturer name
Correct 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.
SOCRA CCRP Investigational Product Management 2
What information is REQUIRED on the label of an investigational product intended for use in a clinical trial?