SOCRA - Society of Clinical Research Associates Investigational Product Management Questions and Answers 2

Question 1

What is investigational product accountability?

Accepted Answer

A system tracking all IP from receipt through dispensing, use, return, and disposition

Answer

Drug accountability tracks the entire lifecycle of IP at a site.

Question 2

What are IP storage requirements?

Accepted Answer

Per label requirements and sponsor instructions, with temperature monitoring and restricted access

Answer

IP must be stored per label, IB, and sponsor instructions with continuous monitoring and restricted access.

Question 3

How should IP be dispensed?

Accepted Answer

Per protocol and randomization, with documentation of subject, product, quantity, date, and lot number

Answer

IP must be dispensed only to enrolled subjects per protocol and randomization with complete documentation.

Question 4

What about unused or expired IP?

Accepted Answer

Return to sponsor or destroy per sponsor instructions with proper documentation

Answer

Unused, expired, or returned IP must be handled per sponsor instructions with proper documentation.

Question 5

When should unblinding occur?

Accepted Answer

Only in medical emergencies when treatment knowledge is essential for patient care

Answer

Unblinding should only occur in medical emergencies when knowing treatment is essential for medical management.

(SOCRA) Society of Clinical Research Associates Practice Test