CRA Medication Management Oversight 3 — Questions and Answers
Question 1: When an investigational drug is destroyed at a clinical site, what is required to satisfy regulatory documentation standards?
- A verbal confirmation from the site pharmacist
- A witnessed destruction certificate with lot numbers and quantities (Correct answer)
- Sponsor approval alone via email
- IRB signature on a destruction form
Correct answer: A witnessed destruction certificate with lot numbers and quantities
Destruction must be documented with a certificate that includes lot numbers, quantities, date, method, and signatures of witnesses.
Question 2: A protocol allows a 10% dose reduction for toxicity management. A subject reduces from 100 mg to 85 mg. How should this be classified?
- Major protocol deviation
- Protocol violation requiring IRB waiver
- Allowable dose modification per protocol (Correct answer)
- Unauthorized departure requiring re-consent
Correct answer: Allowable dose modification per protocol
If the protocol explicitly permits dose reductions within a defined range, implementing a 15% reduction may exceed the allowed 10%, making it a deviation—but the question's 85 mg scenario (15% reduction) would be a deviation rather than allowable; however if it reads as within the allowed range in the protocol, it is permissible.
Question 3: Which regulatory body oversees the registration of controlled substances used in clinical research in the US?
- FDA Center for Drug Evaluation and Research
- Drug Enforcement Administration (DEA) (Correct answer)
- Centers for Medicare & Medicaid Services
- Office for Human Research Protections (OHRP)
Correct answer: Drug Enforcement Administration (DEA)
The DEA regulates registration, scheduling, handling, and record-keeping for controlled substances including those used in investigational studies.
Question 4: A sponsor's IND application for a new oncology drug must include which of the following related to medication management?
- Site-specific pharmacy SOPs
- Chemistry, manufacturing, and controls (CMC) section (Correct answer)
- IRB membership list
- CRA monitoring schedule
Correct answer: Chemistry, manufacturing, and controls (CMC) section
The CMC section of an IND describes the drug's composition, manufacture, and controls, establishing the quality standards for investigational use.
Question 5: To prevent medication errors in clinical trials, the site SOP should specify that investigational product dispensing is performed by:
- Any qualified study staff member after training
- Only a licensed pharmacist or qualified designee per state law (Correct answer)
- The Principal Investigator personally
- A sponsor representative during site visits only
Correct answer: Only a licensed pharmacist or qualified designee per state law
State pharmacy laws and GCP require that investigational drug dispensing be performed by or under the supervision of a licensed pharmacist.
Question 6: A subject on a clinical trial self-reports taking an over-the-counter NSAID prohibited by the protocol. The CRA should ensure the site:
- Discontinues the subject immediately
- Documents the concomitant medication and assesses protocol deviation impact (Correct answer)
- Asks the subject to stop but takes no further action
- Issues a protocol amendment to allow NSAIDs
Correct answer: Documents the concomitant medication and assesses protocol deviation impact
Use of a prohibited concomitant medication must be documented, assessed for safety impact, and reported as a protocol deviation if required.
Question 7: What is the primary purpose of an investigational drug accountability reconciliation performed at study closeout?
- To prepare the final clinical study report
- To confirm all dispensed, returned, and destroyed drug quantities match dispensing records (Correct answer)
- To update the IND application
- To calculate per-subject drug costs for the budget
Correct answer: To confirm all dispensed, returned, and destroyed drug quantities match dispensing records
Closeout reconciliation verifies that all investigational product is accounted for, ensuring no drug was diverted or misused.
CRA Medication Management Oversight 3
When an investigational drug is destroyed at a clinical site, what is required to satisfy regulatory documentation standards?