FDA Responds to Clinical Trials & Part 11 Compliance During COVID-19

0 631

The U.S. Food and Drug Administration (FDA) issued updated guidance on how to conduct clinical trials during the COVID-19 public health emergency. This is the second time the FDA has updated its guidance since it was first issued in March of 2020. In the second update, two questions and answers were added and addressed serious adverse event reporting requirements. The latest version includes a question and answer on collecting electronic signatures and Part 11 compliance (see Q23).

FDA regulations concerning electronic records and electronic signatures are governed by 21 C.F.R. Part 11. Since the final rule’s passage in 1997, FDA has issued several guidance documents that address the scope and application of Part 11 (Sept. 2003) and the use of electronic records and signatures in clinical investigations (June 2017). Considerations for a public health emergency were not addressed in those guidance documents and it seems likely that the question added by the FDA was meant to address that gap. Specifically, the question asked: “What considerations apply to the electronic systems used to generate electronic signatures on clinical trial records, including informed consent documents, during the COVID-19 public health emergency?”

The FDA’s response began by stating that “[e]lectronic systems used to generate electronic signatures on clinical trial records, including informed consent documents, during the COVID-19 public health emergency must comply with the requirements outlined in FDA regulations at 21 CFR part 11 (Part 11) when applicable.” In footnotes, the FDA recommended sponsors and other regulated entities read the 2003 guidance that addresses the scope and application of Part 11. For those not subject to Part 11, the FDA recommended they rely on their internal business practices.

Next, the FDA discussed commercial off-the-shelf (COF) software systems providing electronic signature services for clinical trial records. The FDA explained that it does not certify these systems or methods for Part 11 compliance and how vendors may be able to provide sponsors and other regulated entities with information that their systems are compliant. For vendors that do not supply this information, the FDA reminded the industry that it must take other steps to ensure their systems are compliant.

Last, the FDA addressed there may be situations when an electronic system is unavailable, such as a system used to capture informed consent signatures. In these situations, the FDA stated that “regulated entities must have an alternate means of obtaining required signatures (e.g., handwritten wet ink signatures executed on documents, handwritten stylus or finger-drawn signatures executed on electronic documents that are then printed or appropriately witnessed).” The FDA recommended that when using handwritten methods, “sponsors and other regulated entities should ensure that all records containing original handwritten signatures are (1) collected and archived, as either original paper copies or appropriately certified electronic copies (e.g., using a validated process for scanning paper copies), and (2) retained according to applicable FDA record retention requirements.”

The FDA’s guidance on conducting clinical trials during the COVID-19 public health emergency provides flexibility to sponsors and other regulated entities. It also serves as a reminder of the existing regulations and expectations of compliance.

Leave A Reply

Your email address will not be published.