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 clinical site is closing and the principal investigator is leaving the institution. Regarding trial records, the investigator must:
Answer: Notify the sponsor and arrange for appropriate transfer or storage of records per regulatory and sponsor requirements
When a site closes or an investigator leaves, the sponsor must be notified and records must be transferred or stored according to regulatory and sponsor requirements to maintain their integrity.
Which of the following best describes 'contemporaneous' documentation in the context of GCP?
Answer: Records entered at the same time or as close as possible to when the event or observation occurred
Contemporaneous documentation means recording information at the time of the event or observation, minimizing recall bias and ensuring accuracy.
In a clinical trial, a 'query' issued by the data management team typically requests the investigator to:
Answer: Clarify, correct, or confirm a data discrepancy or missing value in the CRF
Queries are formal requests for investigators to explain, correct, or confirm data entries that appear inconsistent, missing, or outside expected ranges.
Under ICH E6(R2), the essential documents required before the clinical phase of a trial begins include:
Answer: Signed protocol, IB, IRB approval, regulatory authority approvals, investigator CV, and normal value ranges
ICH E6(R2) specifies numerous essential documents required before trial initiation, including the protocol, IB, regulatory/IRB approvals, investigator qualifications, and normal lab ranges.
A site uses paper CRFs but also maintains an electronic laboratory information system (LIS). For source data verification purposes, the LIS printouts are considered:
Answer: Certified copies that may serve as source if they are accurate reproductions of the original
Certified copies that accurately reproduce all original content can serve as source documents per ICH E6(R2) guidance on source data.
An investigator receives a monitoring visit and the monitor requests access to original medical records to verify CRF data. The investigator should:
Answer: Allow access, ensuring subject identifiers are handled per the consent form and applicable regulations
Monitors have the right to access source documents as permitted by the subject's consent form and applicable regulations; the site must facilitate this access.
The principal investigator delegates source document review and CRF completion to a sub-investigator. This delegation must be:
Answer: Documented on a delegation of authority log with the date and scope of delegation
All task delegations must be recorded on a delegation of authority log, specifying who is delegated, what tasks, and when the delegation begins and ends.