SOCRA Essential Study Documents 3 — Questions and Answers
Question 1: Which of the following best defines 'source data' according to ICH E6 GCP?
- Data transferred from CRFs to the sponsor's database
- Original records and certified copies of original records of clinical findings (Correct answer)
- Data entered directly into an EDC system by the sponsor
- Summaries of subject visits prepared by the CRA
Correct 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.
Question 2: According to ALCOA principles, how should an error in a paper CRF be corrected?
- Use correction fluid (white-out) to cover the error and write the new value
- Draw a single line through the error, write the correct value, and initial/date the correction (Correct answer)
- Destroy the page and replace it with a corrected version
- Leave the error and add a note on a separate sheet
Correct 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.
Question 3: A CRA discovers that a CRF entry differs from the source document. What is the correct first step?
- Change the CRF to match the source document without notifying anyone
- Issue a data query to the site to clarify the discrepancy (Correct answer)
- Report the site immediately to the FDA
- Accept the CRF value if it seems clinically reasonable
Correct 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.
Question 4: What is the primary purpose of an audit trail in an electronic data capture (EDC) system?
- To speed up data entry
- To allow sponsors to edit subject data remotely
- To create a secure, time-stamped record of all data entries and changes (Correct answer)
- To automatically lock the database after study closure
Correct 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.
Question 5: Which of the following is NOT considered source data for a clinical trial?
- Hospital medical records
- Physician's handwritten notes from a subject visit
- A completed case report form (CRF) (Correct answer)
- Laboratory printouts from the site's clinical lab
Correct 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.
Question 6: Under 21 CFR Part 11, which of the following is required for electronic records to be considered trustworthy?
- Records must be printed and signed by hand
- Systems must include audit trails, access controls, and validated software (Correct answer)
- Only the sponsor can hold electronic records
- Records must be stored on removable media
Correct 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.
Question 7: A subject's diary card is lost before the data is transcribed to the CRF. What should the site do?
- Reconstruct the diary data from memory and note it in the CRF
- Document the missing source data, notify the sponsor, and leave the CRF field blank or with a query (Correct answer)
- Ask the subject to rewrite the diary entries
- Use data from the previous visit to fill in the gap
Correct 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.
SOCRA Essential Study Documents 3
Which of the following best defines 'source data' according to ICH E6 GCP?