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

Question 1

An investigational drug must be stored between 2°C and 8°C.
A temperature log for the dedicated refrigerator shows a reading of 10°C for a period of four hours.
What is the MOST appropriate immediate action for the site staff to take?

Accepted Answer

Quarantine the affected drug, notify the sponsor, and await instructions on disposition.

Answer

Discard the drug immediately and document it as destroyed in the accountability record.

Answer

Continue dispensing the drug as the excursion was minor and unlikely to affect its stability.

Answer

Recalibrate the thermometer and inform the monitor at the next scheduled site visit.

Question 2

A clinical research coordinator performs a routine inventory of the investigational product and discovers a discrepancy between the dispensing log and the physical count. What is the MOST appropriate first step?

Accepted Answer

Immediately quarantine the remaining stock, document the discrepancy, and notify the Principal Investigator and sponsor.

Answer

Order a new shipment from the sponsor to replace the missing product.

Answer

Inform the monitor at the next scheduled visit.

Answer

Assume a documentation error occurred and adjust the dispensing log to match the physical count.

Question 3

Which of the following is NOT a required element on the label of an investigational product according to 21 CFR 312.6?

Accepted Answer

The name and address of the Principal Investigator.

Answer

The protocol code or study number.

Answer

A statement such as 'Caution: New Drug—Limited by Federal (or United States) law to investigational use.'

Answer

The name or identification code of the drug.

Question 4

At the conclusion of a clinical trial, what is the required procedure for handling unused investigational product at the clinical site?

Accepted Answer

The site must follow the sponsor's instructions for the return or authorized destruction of the unused product.

Answer

The site should destroy all unused product and notify the IRB of the destruction.

Answer

The Principal Investigator may use the remaining product for compassionate use cases.

Answer

The unused product should be returned to the site's general pharmacy stock for dispensing.

Question 5

A participant in a double-blinded trial presents to an outside emergency room with a life-threatening condition. The treating physician believes knowing the treatment assignment is critical for patient care. According to standard procedures, who holds the primary authority and mechanism to grant an emergency unblinding request?

Accepted Answer

The Sponsor or their designated representative (e.g., medical monitor).

Answer

The Chairperson of the Institutional Review Board (IRB).

Answer

The lead research pharmacist at the investigational site.

Answer

The Principal Investigator, who can unblind at their sole discretion.

Question 6

Which of the following documents is the primary, comprehensive record used at a clinical site to track the investigational product from receipt to its final disposition?

Accepted Answer

The Investigational Product Accountability Log.

Answer

The bill of lading from the shipping courier.

Answer

The subject's individual case report forms.

Answer

The Investigator's Brochure.

An investigational drug must be stored between 2°C and 8°C.A temperature log for the dedicated refrigerator shows a reading of 10°C for a period of four hours.What is the MOST appropriate immediate action for the site staff to take?

An investigational drug must be stored between 2°C and 8°C.
A temperature log for the dedicated refrigerator shows a reading of 10°C for a period of four hours.
What is the MOST appropriate immediate action for the site staff to take?