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

Cost of the drug

Answer

Only for controlled substances

Answer

Only pharmacist responsibility

Question 2

What are IP storage requirements?

Accepted Answer

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

Answer

Any room temperature

Answer

Optional

Answer

Only sponsor stores IP

Question 3

How should IP be dispensed?

Accepted Answer

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

Answer

Participants take whatever they want

Answer

Only nurses dispense

Answer

No documentation needed

Question 4

What about unused or expired IP?

Accepted Answer

Return to sponsor or destroy per sponsor instructions with proper documentation

Answer

Regular trash

Answer

Give to other patients

Answer

No procedures required

Question 5

When should unblinding occur?

Accepted Answer

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

Answer

Every visit

Answer

Whenever participant requests

Answer

Sponsor can unblind anytime

Question 6

What is Interactive Response Technology (IRT)?

Accepted Answer

Automated system for randomization, drug assignment, supply management, and inventory tracking

Answer

Patient survey

Answer

Only for AE reporting

Answer

Electronic health record