SOCRA - Society of Clinical Research Associates Source Documentation and Data Questions and Answers 1 — 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?
- Completely obscure the incorrect entry with correction fluid and write the correct value next to it.
- Draw a single line through the incorrect entry, write the correct value nearby, then initial and date the change. (Correct answer)
- Erase the incorrect entry and neatly write the correct value in its place to maintain legibility.
- Leave the source as is and make a note of the correct value only in the electronic Case Report Form (eCRF).
Correct answer: Draw a single line through the incorrect entry, write the correct value nearby, then initial and date the change.
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?
- ICH E6(R2)
- 45 CFR 46 (The Common Rule)
- 21 CFR Part 11 (Correct answer)
- 21 CFR Part 56
Correct answer: 21 CFR Part 11
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?
- Correct the eCRF immediately to match the source document and inform the coordinator.
- 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. (Correct answer)
- Call the subject to verbally confirm their date of birth and document this in the monitoring report.
- Instruct the site staff to alter the source document to match the incorrect eCRF entry to ensure consistency.
Correct 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.
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?
- The data must be saved in a format that will not degrade over the required retention period.
- The data must be recorded at the same time the observation is made.
- The data must be an accurate and truthful representation of the observed fact.
- It must be clear who recorded the data and when it was recorded. (Correct answer)
Correct answer: It must be clear who recorded the data and when it was recorded.
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?
- Original documents, data, and records where trial information is first recorded, such as hospital records, lab notes, or subject diaries. (Correct answer)
- A form provided by the sponsor, either paper or electronic, designed to record all of the protocol-required information for a trial subject.
- A report created by the monitor after a site visit that summarizes all findings and data discrepancies.
- The final, signed clinical study report that is submitted to regulatory authorities for marketing approval.
Correct answer: Original documents, data, and records where trial information is first recorded, such as hospital records, lab notes, or subject diaries.
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.
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?
- For exactly 5 years after the last subject completes their final visit.
- Until the study has been published in a peer-reviewed journal.
- For at least 2 years after the last approval of a marketing application in an ICH region, or after development is formally discontinued. (Correct answer)
- Indefinitely, as part of the subject's permanent medical record.
Correct answer: For at least 2 years after the last approval of a marketing application in an ICH region, or after development is formally discontinued.
ICH GCP E6(R2) Section 4.9.5 and 5.5.12 state that essential documents should be retained for at least 2 years after the last approval of a marketing application in an ICH region, or until there are no pending applications, or for at least 2 years after the formal discontinuation of the investigational product's development. This ensures data is available for regulatory review for a sufficient period.
SOCRA - Society of Clinical Research Associates Source Documentation and Data Questions and Answers 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?