SOCRA Source Documentation and Data 2

Question 1

Which ALCOA principle requires that data be recorded at the time the observation is made?

Accepted Answer

Contemporaneous

Answer

Accurate

Answer

Legible

Answer

Original

Question 2

When correcting an error in a paper source document, what is the correct procedure?

Accepted Answer

Draw a single line through the error, write the correct value, and initial/date the correction

Answer

Use correction fluid to cover the error and write the new value

Answer

Erase the error completely and rewrite the correct value

Answer

Attach a new page and discard the original

Question 3

What does 'source data' refer to under ICH E6(R2) GCP guidelines?

Accepted Answer

All information in original records and certified copies of findings, observations, or other activities

Answer

Only data entered into the sponsor's database

Answer

Data reviewed and approved by the IRB only

Answer

Summarized data submitted in the final study report

Question 4

Which scenario represents a violation of the 'Attributable' ALCOA principle?

Accepted Answer

A data entry clerk enters data under another staff member's login credentials

Answer

A nurse signs their initials next to a recorded vital sign

Answer

A PI dates and signs the protocol signature page

Answer

A CRC documents their own initials on a delegated task

Question 5

A certified copy of a source document is best described as:

Accepted Answer

A verified copy that preserves the content and meaning of the original, often with a certification statement

Answer

A photocopy made by the site coordinator

Answer

Any electronic backup of paper records

Answer

A duplicate original signed by the investigator

Question 6

Which document type is NOT typically considered a primary source document in clinical trials?

Accepted Answer

The sponsor's monitoring report

Answer

Hospital admission records

Answer

Laboratory printouts

Answer

Pharmacy dispensing logs

Question 7

The 'Enduring' attribute added to ALCOA+ means that source data must be:

Accepted Answer

Stored in a way that it remains readable and accessible for the required retention period

Answer

Submitted to the FDA within a defined timeframe

Answer

Backed up daily to a cloud server

Answer

Reviewed by the sponsor at least annually