27 January, 2026
Author : Dr Vijaykumar Gawali

Topic : INVESTIGATIONAL PRODUCT (IP) MANAGEMENT & ACCOUNTABILITY

1 Definition

Investigational Product (IP) refers to the drug, biological product, device, or placebo being tested in a clinical trial.

IP Accountability is the complete system of tracking, storing, dispensing, reconciling, returning, and destroying IP in compliance with ICH-GCP and sponsor SOPs.

2 PI & CRC Responsibilities

PI:

• oversees all IP handling
• ensures staff are trained
• reviews accountability logs
• signs reconciliation

CRC/Pharmacy Staff:

• receive, verify, and log IP
• maintain temperature control
• dispense and counsel patients
• document accountability
• handle returns
• coordinate destruction

3 Step-by-Step IP Management Process

3.1IP Receipt

When shipment arrives:

• Check shipment condition
• Verify batch number, quantity, expiry
• Review shipment temperature data
• If temperature excursion → quarantine
• Document in:
• IP Receipt Log
• IWRS
• Inform sponsor immediately if excursion found

3.2IP Storage

CRC ensures:

• locked, access-controlled storage
• daily temperature monitoring (min/max)
• calibrated temperature devices
• alarm system for temperature deviations
• separate storage for:
• usable IP
• quarantined IP
• returned IP

3.3 IP Dispensing

Before dispensing:

• Confirm subject eligibility
• Verify randomization number in IWRS
• Document dose, quantity, batch
• Counsel participant regarding:
• dosing schedule
• storage
• missed doses
• side-effect reporting
• return of unused IP

Document in:

• Individual IP Accountability Log
• Source notes

3.4 IP Reconciliation

During follow-up visits:

• CRC collects unused/empty containers
• Counts remaining tablets/vials
• Compares with expected use
• Documents discrepancies
• Updates:
• patient accountability log
• master accountability log
• IWRS

3.5 Returns and Destruction

• Sponsor decides whether IP is to be returned or destroyed
• Site cannot destroy IP without sponsor authorization
• IP destruction must be documented with:
• destruction certificate
• batch numbers
• quantity
• signatures of responsible staff

All records filed in ISF.

4 Compliance Requirements

• IP must NEVER be dispensed before SIV activation date
• Access must be limited to delegated personnel
• No mixing of clinical & research drug supplies
• Temperature logs must be contemporaneous
• Deviations (e.g., missed doses) must be reported and documented
• IP reconciliation differences must be explained
• IP expiry changes must be tracked