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

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

Completely obscure the incorrect entry with correction fluid and write the correct value next to it.

Answer

Erase the incorrect entry and neatly write the correct value in its place to maintain legibility.

Answer

Leave the source as is and make a note of the correct value only in the electronic Case Report Form (eCRF).

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

ICH E6(R2)

Answer

45 CFR 46 (The Common Rule)

Answer

21 CFR Part 56

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

Correct the eCRF immediately to match the source document and inform the coordinator.

Answer

Call the subject to verbally confirm their date of birth and document this in the monitoring report.

Answer

Instruct the site staff to alter the source document to match the incorrect eCRF entry to ensure consistency.

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

The data must be saved in a format that will not degrade over the required retention period.

Answer

The data must be recorded at the same time the observation is made.

Answer

The data must be an accurate and truthful representation of the observed fact.

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

A form provided by the sponsor, either paper or electronic, designed to record all of the protocol-required information for a trial subject.

Answer

A report created by the monitor after a site visit that summarizes all findings and data discrepancies.

Answer

The final, signed clinical study report that is submitted to regulatory authorities for marketing approval.

Question 6

According to ICH GCP E6(R2), if the sponsor does not provide specific written instructions on when trial-related records can be destroyed, what is the minimum period the investigator/institution must retain essential documents, including source documents?

Accepted Answer

For at least 2 years after the last approval of a marketing application in an ICH region, or after development is formally discontinued.

Answer

For exactly 5 years after the last subject completes their final visit.

Answer

Until the study has been published in a peer-reviewed journal.

Answer

Indefinitely, as part of the subject's permanent medical record.