Communication and Documentation Flashcards
7 cards from real RA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Communication and Documentation flashcards as text
A research assistant notices a vital sign was recorded in the wrong field of a paper source document. What is the correct way to fix it?
Answer: Draw a single line through the error, write the correct value, then initial and date it
GCP requires corrections that keep the original entry readable and are attributable and dated.
In the ALCOA data integrity principles, what does the 'C' stand for?
Answer: Contemporaneous
ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate; 'contemporaneous' means recorded when the activity happens.
A coordinator documents a study visit three days after it happened. How should the entry be handled?
Answer: Label it as a late entry, give the actual date it was written, and initial it
Late entries are allowed if they are clearly marked and dated with the actual date they were written.
Which document records which study tasks the principal investigator has assigned to each staff member?
Answer: Delegation of authority log
The delegation log lists each person's assigned study duties and is signed by the PI.
A data manager raises a query on an eCRF value that does not match the source document. What should the research assistant do first?
Answer: Check the original source and correct whichever record is wrong, with a documented reason
Query resolution means checking against the source and making a traceable correction or giving a justification.
Under ICH GCP, what is the best description of a 'source document'?
Answer: The original record where clinical findings and observations were first recorded
Source documents are the original records, or certified copies, where trial data were first captured.
A study participant phones the site to report new symptoms. What should the research assistant do with this information?
Answer: Record the call in a dated, signed telephone contact note and notify the investigator
Participant contacts that may be adverse events must be documented promptly and sent to the investigator for assessment.