SOCRA - Society of Clinical Research Associates Source Documentation and Data Questions and Answers 2 — Questions and Answers
Question 1: What are the ALCOA principles for source documentation?
- A filing system
- Attributable, Legible, Contemporaneous, Original, and Accurate (Correct answer)
- An AE classification
- A budgeting method
Correct answer: Attributable, Legible, Contemporaneous, Original, and Accurate
ALCOA requires data to be Attributable, Legible, Contemporaneous, Original, and Accurate.
Attributable: traceable to its maker. Legible: permanently readable. Contemporaneous: recorded at the time. Original: first recording. Accurate: correct. ALCOA+ adds Complete, Consistent, Enduring, Available.
Question 2: What qualifies as a source document?
- Only the CRF
- Original documents including medical charts, lab reports, pharmacy logs, ECG tracings, and participant diaries (Correct answer)
- Only electronic records
- Only sponsor documents
Correct answer: Original documents including medical charts, lab reports, pharmacy logs, ECG tracings, and participant diaries
Source documents are all original records where clinical data are first recorded.
Examples: hospital records, clinic charts, lab reports, diagnostic imaging, ECG tracings, pharmacy logs, subject diaries, automated instrument output. The CRF may serve as source for data with no other original record.
Question 3: What is SDV's role in data quality?
- Optional and rarely performed
- Comparing CRF data against source documents to confirm accuracy, completeness, and consistency (Correct answer)
- Only checks demographics
- Only at trial end
Correct answer: Comparing CRF data against source documents to confirm accuracy, completeness, and consistency
SDV involves monitors comparing CRF entries against original source documents.
The monitor verifies accuracy, completeness, consistency, and timeliness. ICH E6(R2) allows reduced SDV for lower-risk data, focusing on critical elements. Centralized monitoring can complement on-site SDV.
Question 4: How should electronic source data be managed?
- No special requirements
- In validated systems with audit trails, access controls, backups, and 21 CFR Part 11 compliance (Correct answer)
- Only paper is valid
- Can be freely modified
Correct answer: In validated systems with audit trails, access controls, backups, and 21 CFR Part 11 compliance
Electronic source data must comply with 21 CFR Part 11 including validation, audit trails, and access controls.
Requirements: system validation, complete audit trail, role-based access, electronic signatures, regular backups, disaster recovery, data migration procedures, retention in readable format, and SOPs.
Question 5: What is a data query?
- Request for medication
- A formal question about unclear or erroneous data requiring site investigation and resolution (Correct answer)
- Only generated by IRB
- Resolved without documentation
Correct answer: A formal question about unclear or erroneous data requiring site investigation and resolution
A query is a formal request for clarification or correction of unclear, inconsistent, or erroneous data.
Generated when data is missing, out of range, inconsistent, or differs from source. Management: generation, communication, investigation, response, verification, closure, and documentation with audit trail.
Question 6: What is a certified copy?
- Any photocopy
- A verified exact, complete, and unaltered reproduction of the original (Correct answer)
- Never acceptable
- Only FDA can create them
Correct answer: A verified exact, complete, and unaltered reproduction of the original
A certified copy is verified to be an exact, complete, and unaltered reproduction of the original.
ICH E6(R2) recognizes certified copies. Must be exact, complete, unaltered, verified by signature or validated process. Both paper and electronic certified copies are acceptable if properly documented.
SOCRA - Society of Clinical Research Associates Source Documentation and Data Questions and Answers 2
What are the ALCOA principles for source documentation?