Investigational Product Management Flashcards

Which document formally authorizes a site to begin receiving and storing investigational product?

Answer: A confirmed IRB approval letter, signed protocol, and completed 1572, with sponsor confirmation of site activation

A site must have all regulatory and contractual requirements in place — including IRB approval, signed protocol and 1572, and sponsor activation confirmation — before IP can be shipped or dispensed.

When a clinical trial uses an interactive response technology (IRT/IVRS/IWRS) system for randomization and IP management, the system's primary functions include:

Answer: Managing subject randomization, treatment assignment, and investigational product dispensing and resupply logistics

IRT systems (IVRS for voice, IWRS for web) are used to randomize subjects, assign treatment, manage IP kit assignment, and trigger resupply orders based on site inventory levels.

A 'comparator product' in a clinical trial refers to:

Answer: An approved product (or placebo) used as a reference against which the investigational product is evaluated

The comparator is an approved medicinal product or placebo used in a controlled trial to compare against the investigational product's safety and efficacy profile.

Site staff may not open or break the blind of randomization codes except:

Answer: When medically necessary for subject safety (e.g., medical emergency) following the pre-defined emergency unblinding procedure

Emergency unblinding is permitted only when knowledge of treatment is medically necessary to protect the subject, and must follow a documented procedure with notification to the sponsor.

When investigational product is transferred between two investigational sites, which step is MOST critical?

Answer: Obtaining sponsor approval and ensuring complete chain of custody documentation with temperature monitoring during transfer

Site-to-site IP transfers require sponsor authorization and complete documentation of the chain of custody, including temperature conditions during transit, to maintain product integrity and accountability.

Which of the following best describes 'open-label' trial design with respect to investigational product management?

Answer: Both subjects and investigators know which treatment is being administered, with no blinding of treatment assignment

In an open-label trial, there is no blinding — both the subject and the site staff know which treatment the subject is receiving, simplifying IP management but introducing potential bias.