Essential Study Documents 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 Essential Study Documents flashcards as text
Which of the following best defines 'source data' according to ICH E6 GCP?
Answer: Original records and certified copies of original records of clinical findings
ICH E6 defines source data as all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial.
According to ALCOA principles, how should an error in a paper CRF be corrected?
Answer: Draw a single line through the error, write the correct value, and initial/date the correction
GCP requires errors be corrected with a single line through the original entry so it remains legible, followed by the correct value, the corrector's initials, and date.
A CRA discovers that a CRF entry differs from the source document. What is the correct first step?
Answer: Issue a data query to the site to clarify the discrepancy
The CRA should issue a data query to the site so the discrepancy can be reviewed, explained, and corrected by authorized site staff.
What is the primary purpose of an audit trail in an electronic data capture (EDC) system?
Answer: To create a secure, time-stamped record of all data entries and changes
An audit trail provides a chronological, secure record showing who entered, changed, or deleted data and when, ensuring data integrity and traceability.
Which of the following is NOT considered source data for a clinical trial?
Answer: A completed case report form (CRF)
A CRF is a transcription of source data, not source data itself, unless it is designated as the original source for a specific data point.
Under 21 CFR Part 11, which of the following is required for electronic records to be considered trustworthy?
Answer: Systems must include audit trails, access controls, and validated software
21 CFR Part 11 requires electronic records to have audit trails, limited system access controls, and validated computer systems to ensure integrity.
A subject's diary card is lost before the data is transcribed to the CRF. What should the site do?
Answer: Document the missing source data, notify the sponsor, and leave the CRF field blank or with a query
When source data is lost, the site must document the loss, notify the sponsor, and resolve via the protocol-defined missing data procedure rather than reconstructing from memory.