Data Management Flashcards
6 cards from real SOCRA CCRP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Data Management flashcards as text
What does 21 CFR Part 11 govern in clinical research?
Answer: Electronic records and electronic signatures
21 CFR Part 11 establishes FDA criteria under which electronic records and electronic signatures are considered trustworthy and equivalent to paper records.
What is the 'audit trail' requirement under 21 CFR Part 11?
Answer: A computer-generated, time-stamped record of who created, modified, or deleted electronic data
An audit trail is a secure, computer-generated, time-stamped record that independently logs operator entries and actions to reconstruct the course of events.
In clinical data management, what does 'source data' refer to?
Answer: Original information in original records and certified copies used as the basis of a clinical trial
Source data is the original information first recorded in source documents such as hospital records, clinical charts, lab notes, or diaries.
What is a 'data query' in clinical trial data management?
Answer: A question raised to resolve a discrepancy or missing data in the case report form
A data query is a formal request sent to site personnel to clarify, correct, or provide missing information identified during data review.
Which principle requires that clinical trial data be attributable, legible, contemporaneous, original, and accurate?
Answer: ALCOA principle
The ALCOA principle (Attributable, Legible, Contemporaneous, Original, Accurate) defines the fundamental data quality standards in GCP.
What is an eCRF in clinical research?
Answer: An electronic case report form used to collect study data
An eCRF (electronic Case Report Form) is an electronic format for collecting and transmitting clinical trial data from the investigative site to the sponsor.