SOCRA - Society of Clinical Research Associates Investigational Product Management Questions and Answers 2 — Questions and Answers
Question 1: What is investigational product accountability?
- Cost of the drug
- A system tracking all IP from receipt through dispensing, use, return, and disposition (Correct answer)
- Only for controlled substances
- Only pharmacist responsibility
Correct answer: A system tracking all IP from receipt through dispensing, use, return, and disposition
Drug accountability tracks the entire lifecycle of IP at a site.
Must document receipt, storage conditions, dispensing to subjects, returns, destruction or return to sponsor, and final reconciliation. Ensures protocol compliance, safety, and prevention of diversion.
Question 2: What are IP storage requirements?
- Any room temperature
- Per label requirements and sponsor instructions, with temperature monitoring and restricted access (Correct answer)
- Optional
- Only sponsor stores IP
Correct answer: Per label requirements and sponsor instructions, with temperature monitoring and restricted access
IP must be stored per label, IB, and sponsor instructions with continuous monitoring and restricted access.
Requirements: labeled temperature conditions, continuous monitoring with calibrated devices, excursion procedures, restricted access, secure separate storage, light protection if needed, and expiration monitoring.
Question 3: How should IP be dispensed?
- Participants take whatever they want
- Per protocol and randomization, with documentation of subject, product, quantity, date, and lot number (Correct answer)
- Only nurses dispense
- No documentation needed
Correct answer: Per protocol and randomization, with documentation of subject, product, quantity, date, and lot number
IP must be dispensed only to enrolled subjects per protocol and randomization with complete documentation.
Verify enrollment and eligibility, confirm treatment assignment, check product identity and expiration, document in accountability log, and provide subject instructions for administration and storage.
Question 4: What about unused or expired IP?
- Regular trash
- Return to sponsor or destroy per sponsor instructions with proper documentation (Correct answer)
- Give to other patients
- No procedures required
Correct answer: Return to sponsor or destroy per sponsor instructions with proper documentation
Unused, expired, or returned IP must be handled per sponsor instructions with proper documentation.
Returns documented and reconciled. Expired product quarantined. Sponsor provides disposition instructions. Destruction follows environmental regulations, must be witnessed and documented with certificate.
Question 5: When should unblinding occur?
- Every visit
- Only in medical emergencies when treatment knowledge is essential for patient care (Correct answer)
- Whenever participant requests
- Sponsor can unblind anytime
Correct answer: Only in medical emergencies when treatment knowledge is essential for patient care
Unblinding should only occur in medical emergencies when knowing treatment is essential for medical management.
Protocol should define circumstances, who has authority, the procedure, documentation requirements, sponsor notification, data handling implications, and whether the subject should be discontinued.
Question 6: What is Interactive Response Technology (IRT)?
- Patient survey
- Automated system for randomization, drug assignment, supply management, and inventory tracking (Correct answer)
- Only for AE reporting
- Electronic health record
Correct answer: Automated system for randomization, drug assignment, supply management, and inventory tracking
IRT automates randomization, treatment assignment, drug supply management, and inventory tracking.
Functions include randomization, automated supply management, real-time inventory tracking, dispensing confirmations, dose modifications, emergency unblinding, drug return tracking, and re-supply calculations. Must be 21 CFR Part 11 validated.
SOCRA - Society of Clinical Research Associates Investigational Product Management Questions and Answers 2
What is investigational product accountability?