SOCRA Source Documentation and Data 2 — Questions and Answers
Question 1: Which ALCOA principle requires that data be recorded at the time the observation is made?
- Accurate
- Legible
- Contemporaneous (Correct answer)
- Original
Correct answer: Contemporaneous
Contemporaneous means data must be recorded at the time the observation occurs, not reconstructed later from memory.
Question 2: When correcting an error in a paper source document, what is the correct procedure?
- Use correction fluid 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)
- Erase the error completely and rewrite the correct value
- Attach a new page and discard the original
Correct answer: Draw a single line through the error, write the correct value, and initial/date the correction
A single line through the error preserves the original entry while clearly indicating the correction, with initials and date for accountability.
Question 3: What does 'source data' refer to under ICH E6(R2) GCP guidelines?
- Only data entered into the sponsor's database
- All information in original records and certified copies of findings, observations, or other activities (Correct answer)
- Data reviewed and approved by the IRB only
- Summarized data submitted in the final study report
Correct answer: All information in original records and certified copies of findings, observations, or other activities
ICH E6(R2) defines source data as all information in original records and certified copies used to reconstruct and evaluate a clinical trial.
Question 4: Which scenario represents a violation of the 'Attributable' ALCOA principle?
- A nurse signs their initials next to a recorded vital sign
- A data entry clerk enters data under another staff member's login credentials (Correct answer)
- A PI dates and signs the protocol signature page
- A CRC documents their own initials on a delegated task
Correct answer: A data entry clerk enters data under another staff member's login credentials
Using another person's login credentials violates attributability because the data cannot be traced to the person who actually performed or recorded it.
Question 5: A certified copy of a source document is best described as:
- A photocopy made by the site coordinator
- A verified copy that preserves the content and meaning of the original, often with a certification statement (Correct answer)
- Any electronic backup of paper records
- A duplicate original signed by the investigator
Correct answer: A verified copy that preserves the content and meaning of the original, often with a certification statement
A certified copy is one that has been verified to be an exact and complete copy of the original, preserving all data and attributes.
Question 6: Which document type is NOT typically considered a primary source document in clinical trials?
- Hospital admission records
- Laboratory printouts
- The sponsor's monitoring report (Correct answer)
- Pharmacy dispensing logs
Correct answer: The sponsor's monitoring report
Monitoring reports are prepared by the sponsor or CRO and reflect observations made during site visits; they are not original source documents.
Question 7: The 'Enduring' attribute added to ALCOA+ means that source data must be:
- Submitted to the FDA within a defined timeframe
- Stored in a way that it remains readable and accessible for the required retention period (Correct answer)
- Backed up daily to a cloud server
- Reviewed by the sponsor at least annually
Correct answer: Stored in a way that it remains readable and accessible for the required retention period
Enduring means data must be stored in durable formats that remain legible and retrievable throughout the required retention period.
SOCRA Source Documentation and Data 2
Which ALCOA principle requires that data be recorded at the time the observation is made?