CCRA Investigational Product Management 3

Question 1

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

Accepted Answer

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

Answer

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.

Question 2

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

Accepted Answer

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

Answer

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.

Question 3

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

Accepted Answer

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

Answer

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.

Question 4

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

Accepted Answer

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

Answer

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.

Question 5

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

Accepted Answer

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

Answer

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.

CCRA - Certified Clinical Research Associate Practice Test

CCRA - Certified Clinical Research Associate Practice Test

CCRA Investigational Product Management 3