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
Which document formally defines the data to be collected, the CRF structure, and the validation rules for a clinical trial?
Answer: The data management plan
The data management plan (DMP) specifies how data will be collected, managed, and validated throughout the trial, including CRF design and edit checks.
When must a serious adverse event (SAE) be documented in the source record?
Answer: As soon as it is identified or reported by the subject
GCP requires contemporaneous documentation; SAEs must be recorded in the source record as soon as they are identified or reported.
A monitor reviewing source documents notices that several lab values are recorded in the CRF but cannot be found in the hospital chart. This situation is called:
Answer: A source data verification failure or data inconsistency
When CRF data cannot be traced to a source document, this represents a source data verification (SDV) failure indicating a data integrity concern.
In electronic records, 21 CFR Part 11 requires that electronic signatures be:
Answer: Linked to their respective electronic records and include the printed name, date/time, and meaning of signature
21 CFR Part 11 mandates that electronic signatures include the printed name of the signer, date/time of signing, and the meaning of the signature (e.g., approval, review).
Protocol amendments that change study procedures must be reflected in the source documents by:
Answer: Documenting the amendment approval date and updating procedures in subsequent visit notes
Once an amendment is approved, subsequent documentation should reflect the updated procedures, noting the amendment effective date in the records.
When a subject withdraws from a clinical trial, the investigator should document:
Answer: The subject's reason for withdrawal, last contact date, and any follow-up safety data obtained
GCP requires documentation of the reason for withdrawal, date of last contact, and any available safety follow-up data to ensure complete and accurate records.
Which term describes the process of comparing CRF data against the original source documents at the clinical site?
Answer: Source data verification (SDV)
Source data verification (SDV) is the monitoring activity of checking CRF data against source documents to confirm accuracy and completeness.