CRA Investigational Product Management 1 — Questions and Answers
Question 1: What document must be maintained at a clinical site to track the receipt, dispensing, and return or destruction of investigational product?
- Adverse Event Log
- Drug Accountability Log (Correct answer)
- Protocol Deviation Log
- Site Initiation Report
Correct answer: Drug Accountability Log
The Drug Accountability Log tracks all investigational product movements including receipt, dispensing to subjects, returns, and destruction to ensure complete accountability.
Question 2: Which temperature range is defined as 'controlled room temperature' per USP standards for investigational product storage?
- 2°C to 8°C
- 15°C to 30°C (Correct answer)
- -20°C to -10°C
- 30°C to 40°C
Correct answer: 15°C to 30°C
USP defines controlled room temperature as 15°C to 30°C (59°F to 86°F), which is the standard for products requiring room temperature storage.
Question 3: Who bears ultimate responsibility for the proper use, storage, and accountability of investigational product at a clinical site?
- The Sponsor's Medical Monitor
- The Principal Investigator (Correct answer)
- The IRB Chairperson
- The FDA District Office
Correct answer: The Principal Investigator
The Principal Investigator bears ultimate responsibility for all trial activities at the site, including proper handling and accountability of investigational product.
Question 4: What should a CRA do upon discovering a temperature excursion in the investigational product storage area during a monitoring visit?
- Immediately destroy all affected product
- Document the excursion and notify the sponsor for product integrity assessment (Correct answer)
- Continue dispensing the product without action
- Return all product to the manufacturer without documentation
Correct answer: Document the excursion and notify the sponsor for product integrity assessment
Temperature excursions must be documented and reported to the sponsor, who will assess product integrity and provide guidance on whether the affected product can continue to be used.
Question 5: In a double-blind clinical trial, what is the key requirement for investigational product labeling?
- Both the subject and investigator must know the treatment assignment
- Labels must not reveal whether the product is active drug or placebo (Correct answer)
- Two investigators must co-sign each dispensing record
- Products must be stored in two separate locked locations
Correct answer: Labels must not reveal whether the product is active drug or placebo
Double-blind trial labeling must be coded so neither the subject nor the investigator can determine whether the product is active drug or placebo, preserving the blind.
Question 6: Which document specifies the authorized dosing amount and schedule of investigational product to be dispensed to each subject?
- Informed Consent Form
- Case Report Form
- The Clinical Protocol (Correct answer)
- Site Qualification Report
Correct answer: The Clinical Protocol
The clinical protocol contains all dosing instructions, including the amount, frequency, and schedule of investigational product to be dispensed to study subjects.
Question 7: During drug reconciliation, what accounting equation is the CRA verifying?
- IP received minus adverse events equals IP on hand
- IP received = IP dispensed + IP on hand + IP returned or destroyed (Correct answer)
- IP dispensed equals the number of enrolled subjects
- IP received minus IP on hand equals protocol deviations
Correct answer: IP received = IP dispensed + IP on hand + IP returned or destroyed
Drug reconciliation confirms that IP received equals the sum of IP dispensed to subjects, IP remaining on hand, and IP returned or destroyed, ensuring complete accountability.
CRA Investigational Product Management 1
What document must be maintained at a clinical site to track the receipt, dispensing, and return or destruction of investigational product?