SOCRA CCRP Investigational Product Management 1 — Questions and Answers
Question 1: Who is primarily responsible for maintaining investigational product accountability records at a clinical trial site?
- The sponsor's monitor
- The principal investigator or designee (Correct answer)
- The IRB/IEC
- The site's pharmacy regulatory board
Correct answer: The principal investigator or designee
Under ICH GCP E6(R2), the principal investigator or their designee is responsible for maintaining accurate IP accountability records at the site.
Question 2: According to ICH GCP E6(R2), investigational products must be stored under conditions specified by:
- The site's standard operating procedures
- The IRB approval letter
- The sponsor's protocol and investigational product information (Correct answer)
- FDA general pharmaceutical storage guidelines
Correct answer: The sponsor's protocol and investigational product information
ICH GCP requires IP to be stored according to conditions specified by the sponsor in the protocol or in the IP information provided to the site.
Question 3: What document is used at a clinical trial site to track all dispensing, administration, and returns of investigational product?
- Case Report Form (CRF)
- Investigational Product Accountability Log (Correct answer)
- Protocol Deviation Log
- Source document worksheets
Correct answer: Investigational Product Accountability Log
The IP Accountability Log records all transactions involving investigational product, including receipt, dispensing, administration, and return or destruction.
Question 4: When an investigational product shipment is received at a clinical site, what is the FIRST action the site should take?
- Begin dispensing immediately to enrolled subjects
- Notify the IRB of shipment receipt
- Inspect and document the shipment against the packing slip and protocol requirements (Correct answer)
- Destroy the outer packaging
Correct answer: Inspect and document the shipment against the packing slip and protocol requirements
Upon receipt, the site must inspect the shipment for condition, quantity, and storage compliance and document findings against the packing slip.
Question 5: A temperature excursion is detected in the IP storage refrigerator over a weekend. What is the appropriate FIRST action?
- Dispose of all affected IP immediately
- Continue using the IP and document the excursion in the deviation log
- Quarantine the affected IP and notify the sponsor (Correct answer)
- Return the IP to the subject and document the event
Correct answer: Quarantine the affected IP and notify the sponsor
Affected IP must be quarantined and the sponsor notified so the sponsor can assess whether the product remains suitable for use.
Question 6: At study close-out, what typically happens to unused investigational product?
- It is discarded by the site pharmacy at their discretion
- It is returned to the sponsor or destroyed per sponsor instructions with full documentation (Correct answer)
- It is kept by the site for potential future use
- It is donated to the local hospital pharmacy
Correct answer: It is returned to the sponsor or destroyed per sponsor instructions with full documentation
Unused IP must be returned to the sponsor or destroyed per sponsor instructions, with all transactions documented in the accountability log.
Question 7: Which of the following best describes 'blinded' investigational product in a randomized controlled trial?
- IP that has been destroyed and is no longer usable
- IP where the identity of active drug versus placebo is concealed from participants and/or investigators (Correct answer)
- IP stored in a dark environment to prevent photodegradation
- IP that has failed quality control testing
Correct answer: IP where the identity of active drug versus placebo is concealed from participants and/or investigators
In blinded trials, the identity of the investigational product (active versus placebo) is concealed to reduce bias in the conduct and evaluation of the trial.
SOCRA CCRP Investigational Product Management 1
Who is primarily responsible for maintaining investigational product accountability records at a clinical trial site?