Medication Management Oversight Flashcards
7 cards from real CRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Medication Management Oversight flashcards as text
When an investigational drug is destroyed at a clinical site, what is required to satisfy regulatory documentation standards?
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.
A protocol allows a 10% dose reduction for toxicity management. A subject reduces from 100 mg to 85 mg. How should this be classified?
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.
Which regulatory body oversees the registration of controlled substances used in clinical research in the US?
Answer: Drug Enforcement Administration (DEA)
The DEA regulates registration, scheduling, handling, and record-keeping for controlled substances including those used in investigational studies.
A sponsor's IND application for a new oncology drug must include which of the following related to medication management?
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.
To prevent medication errors in clinical trials, the site SOP should specify that investigational product dispensing is performed by:
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.
A subject on a clinical trial self-reports taking an over-the-counter NSAID prohibited by the protocol. The CRA should ensure the site:
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.
What is the primary purpose of an investigational drug accountability reconciliation performed at study closeout?
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.