Clinical Documentation & Records Flashcards
7 cards from real CPI practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Clinical Documentation & Records flashcards as text
A site receives a request from an FDA inspector to review trial master file documents during an inspection. The site should:
Answer: Cooperate fully and provide access to all requested trial documents in a timely manner
Investigators are legally obligated to permit FDA inspection of all trial records; obstruction or delay can result in regulatory sanctions.
What is the purpose of maintaining a subject screening and enrollment log?
Answer: To document all subjects screened, reasons for screen failures, and enrolled subject identifiers
Screening and enrollment logs document all subjects considered for the trial, screen failure reasons, and enrolled subject IDs to demonstrate recruitment transparency.
Which scenario represents a violation of the 'attributable' principle in ALCOA documentation standards?
Answer: A research coordinator enters data using the principal investigator's login credentials
Using another person's credentials to enter data violates the attributable principle, which requires that data entries be traceable to the individual who actually made them.
A protocol requires fasting blood draws, but the site note indicates the subject ate breakfast on the day of the draw. The investigator should:
Answer: Document the actual condition (non-fasting), record the protocol deviation, and notify the sponsor and IRB per protocol requirements
Protocol deviations must be accurately documented in the source record and reported to the sponsor and IRB regardless of whether they affect lab values.
In the context of clinical trial records, a 'certified copy' is defined as:
Answer: A copy that has been verified to be a complete and accurate reproduction of the original document
ICH E6(R2) defines a certified copy as one verified to be an accurate and complete reproduction of the original, regardless of medium.
A clinical investigator must ensure that all CRF data can be traced back to source documents. This principle is known as:
Answer: Source data traceability
Source data traceability ensures that every CRF entry can be verified against its originating source document, supporting data integrity.
When an investigational product is dispensed to a subject, which record must be updated at the clinical site?
Answer: The investigational product accountability log
Investigational product accountability logs must be updated at each dispensing to document the amount dispensed, lot number, subject ID, and date.