SOCRA - Society of Clinical Research Associates Source Documentation and Data Questions and Answers 1

Question 1

A research coordinator records a participant's blood pressure as 140/90 mmHg in the paper source chart. Later, they realize the correct reading was 120/80 mmHg. According to Good Clinical Practice (GCP) principles for correcting source documents, what is the proper procedure?

Accepted Answer

Draw a single line through the incorrect entry, write the correct value nearby, then initial and date the change.

Answer

ICH GCP guidelines require that any change or correction to a source document should be traceable, not obscure the original entry, and be explained if necessary. The standard procedure is to draw a single line through the error so it remains legible, write the correct information, and then add one's initials and the date to attribute the change.

Question 2

A clinical trial is using a validated electronic system for participants to directly enter their daily symptom information via a smartphone app. This data is considered eSource. To be compliant with FDA regulations, this electronic system must primarily adhere to which of the following standards for electronic records and signatures?

Accepted Answer

21 CFR Part 11

Answer

21 CFR Part 11 is the FDA regulation that establishes the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. It is critical for systems capturing eSource data in FDA-regulated trials, ensuring features like audit trails, system validation, and security are in place.

Question 3

During a monitoring visit, a Clinical Research Associate (CRA) finds a discrepancy where the subject's date of birth in the eCRF does not match the date of birth in the hospital's electronic medical record, which is the designated source document. What is the MOST appropriate action for the CRA to take?

Accepted Answer

Issue a data query to the site staff, identifying the discrepancy and requesting they review the source and make the necessary correction or provide clarification.

Answer

The CRA's role is to verify data against the source and identify discrepancies, not to alter study data. The correct procedure is to issue a formal query. This prompts the site staff, who are responsible for data entry, to investigate the discrepancy, refer back to the source, and make the official correction in the eCRF, thereby maintaining a proper audit trail.

Question 4

The data quality principle 'Attributable' is a core component of the ALCOA+ acronym. In the context of source documentation, what does this principle require?

Accepted Answer

It must be clear who recorded the data and when it was recorded.

Answer

Attributable means that the data can be traced back to the individual who collected or generated it. This is typically accomplished by the person initialing and dating the entry in a paper record or via a secure, unique user login in a validated electronic system that captures the user and timestamp in an audit trail.

Question 5

Which of the following is the best definition of a source document according to ICH GCP guidelines?

Accepted Answer

Original documents, data, and records where trial information is first recorded, such as hospital records, lab notes, or subject diaries.

Answer

ICH GCP 1.52 defines source documents as the original records (and certified copies) of clinical findings, observations, or other activities in a trial. This is where the data is first recorded. A Case Report Form (CRF) is used to transcribe this data for the sponsor, but the original record itself is the source document.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA - Society of Clinical Research Associates Source Documentation and Data Questions and Answers 1