Source Documentation and Data Flashcards
7 cards from real SOCRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Source Documentation and Data flashcards as text
Which ALCOA principle requires that data be recorded at the time the observation is made?
Answer: Contemporaneous
Contemporaneous means data must be recorded at the time the observation occurs, not reconstructed later from memory.
When correcting an error in a paper source document, what is the correct procedure?
Answer: Draw a single line through the error, write the correct value, and initial/date the correction
A single line through the error preserves the original entry while clearly indicating the correction, with initials and date for accountability.
What does 'source data' refer to under ICH E6(R2) GCP guidelines?
Answer: All information in original records and certified copies of findings, observations, or other activities
ICH E6(R2) defines source data as all information in original records and certified copies used to reconstruct and evaluate a clinical trial.
Which scenario represents a violation of the 'Attributable' ALCOA principle?
Answer: A data entry clerk enters data under another staff member's login credentials
Using another person's login credentials violates attributability because the data cannot be traced to the person who actually performed or recorded it.
A certified copy of a source document is best described as:
Answer: A verified copy that preserves the content and meaning of the original, often with a certification statement
A certified copy is one that has been verified to be an exact and complete copy of the original, preserving all data and attributes.
Which document type is NOT typically considered a primary source document in clinical trials?
Answer: The sponsor's monitoring report
Monitoring reports are prepared by the sponsor or CRO and reflect observations made during site visits; they are not original source documents.
The 'Enduring' attribute added to ALCOA+ means that source data must be:
Answer: Stored in a way that it remains readable and accessible for the required retention period
Enduring means data must be stored in durable formats that remain legible and retrievable throughout the required retention period.