SOCRA CCRP Data Management 1 — Questions and Answers
Question 1: What does 21 CFR Part 11 govern in clinical research?
- IRB review procedures
- Electronic records and electronic signatures (Correct answer)
- Investigational drug labeling
- Adverse event reporting timelines
Correct 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.
Question 2: What is the 'audit trail' requirement under 21 CFR Part 11?
- A financial record of trial expenses
- A computer-generated, time-stamped record of who created, modified, or deleted electronic data (Correct answer)
- A log of all adverse events
- A record of all subject visits
Correct 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.
Question 3: In clinical data management, what does 'source data' refer to?
- Data entered into the sponsor's database
- Original information in original records and certified copies used as the basis of a clinical trial (Correct answer)
- Data generated by the CRO
- Summarized data in the final study report
Correct 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.
Question 4: What is a 'data query' in clinical trial data management?
- A request to enroll additional subjects
- A question raised to resolve a discrepancy or missing data in the case report form (Correct answer)
- A sponsor's request for interim analysis
- A regulatory agency inquiry about the study
Correct 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.
Question 5: Which principle requires that clinical trial data be attributable, legible, contemporaneous, original, and accurate?
- SMART principle
- ALCOA principle (Correct answer)
- CDISC standard
- GLP principle
Correct answer: ALCOA principle
The ALCOA principle (Attributable, Legible, Contemporaneous, Original, Accurate) defines the fundamental data quality standards in GCP.
Question 6: What is an eCRF in clinical research?
- An electronic clinical research file
- An electronic case report form used to collect study data (Correct answer)
- An electronic conflict-of-interest reporting form
- An electronic compliance review form
Correct 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.
SOCRA CCRP Data Management 1
What does 21 CFR Part 11 govern in clinical research?