Data Management & Informatics Flashcards

The FDA regulation 21 CFR Part 11 is a foundational component of modern clinical trial data management. What is its primary purpose?

Answer: To establish the standards under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.

21 CFR Part 11 provides the criteria for the FDA to accept electronic records and signatures as being as valid as their paper-based counterparts. It does not mandate specific software or the use of electronic systems, nor does it supersede HIPAA; rather, it ensures the integrity, authenticity, and confidentiality of electronic data submitted to the FDA.

A CRC is transcribing a participant's weight from a source document into the Electronic Data Capture (EDC) system. The source clearly states the weight is 90.5 kg. When the CRC enters "90.5" into the weight field, an automated edit check fires a query stating, "Value is outside the expected range of 100-250. Please confirm." The CRC realizes the EDC was mistakenly programmed to expect the value in pounds (lbs). What is the most appropriate action?

Answer: Do not change the data; respond to the query stating that the value of 90.5 kg is correct per the source document and that the edit check requires review.

The fundamental rule of data entry is that the data in the Case Report Form (CRF) must accurately reflect the source document. Changing the value to fit the incorrect edit check constitutes data manipulation. The correct action is to enter the accurate data from the source, and use the query system to communicate the discrepancy and flag the system programming error to the data management team.

At the conclusion of a clinical trial, after all data has been entered, cleaned, and all queries resolved, the sponsor performs a "database lock." What is the primary significance of this action?

Answer: It prevents any further changes to the data, creating a static dataset for final statistical analysis.

A database lock is a critical milestone that marks the transition from data collection and cleaning to data analysis. Once the database is locked, no further alterations to the data are permitted, which ensures the integrity and reproducibility of the final analysis that will be used for the clinical study report and regulatory submissions.

A CRC measures a participant's blood pressure and immediately records the value, along with the time, date, and their initials, on the designated paper source worksheet. This practice best exemplifies which principle of ALCOA-C?

Answer: Contemporaneous

The principle of 'Contemporaneous' requires that data be recorded at the time it is generated or observed. By documenting the blood pressure reading immediately after taking it, the CRC ensures the record reflects the real-time event, preventing errors from recall. While the initials make it 'Attributable' and the value should be 'Accurate', the act of recording it *immediately* is the key to it being 'Contemporaneous'.

During a monitoring visit, the monitor needs to perform source data verification (SDV) for a participant's concomitant medications listed in the eCRF. Which of the following would be considered the most reliable primary source document for this information?

Answer: The participant's official electronic health record (EHR) or signed progress notes from their medical file.

Source data is the original record of clinical findings, observations, or other activities. The participant's official medical record (EHR or paper chart) is the most reliable source because it is a part of their routine clinical care. The eCRF is a transcription of the source, a self-reported log is subject to recall bias, and the IP accountability log only tracks the study drug.

A CRC receives an automated query in the EDC system because a participant, enrolled under an inclusion criterion of "age 18-75," has a calculated age of 76. The CRC verifies against the participant's driver's license (the source document) that the date of birth was entered correctly and the participant was, in fact, ineligible. What is the CRC's most appropriate action?

Answer: Respond to the query confirming the data is accurate per the source, and immediately report the enrollment of an ineligible participant as a protocol deviation.

Data integrity requires that the information in the EDC accurately reflects the source. The correct action is to confirm the data's accuracy in the query response. Concurrently, the enrollment of an ineligible participant is a protocol deviation that must be documented and reported immediately to the PI and, subsequently, the IRB/sponsor according to the site's SOPs.