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obtain Part 11 compliant electronic signatures, but COTS vendors may be able to provide sponsors and other regulated entities with information regarding whether their systems are Part 11 compliant. When such information is unavailable from the vendor, and a Part 11 compliant electronic system is required, sponsors and other regulated entities must take other steps to ensure the electronic system or software in use is Part 11 compliant. For further information regarding Part 11 compliance, see FDA’s guidance for industry Part 11, Electronic Records; Electronic Signatures—Scope and Application (August 2003)78 and the additional recommendations proposed in the draft guidance for industry Use of Electronic Records and Electronic Signatures in Clinical Investigations under 21 CFR Part 11— Questions and Answers (June 2017).79 When an electronic system that is Part 11 compliant is not available, regulated entities must have an alternate means of obtaining required signatures (e.g., handwritten80 wet ink signatures executed on documents, handwritten stylus or finger-drawn signatures executed on electronic documents that are then printed or appropriately witnessed). Alternative methods for obtaining signatures on informed consent documents during the COVID-19 public health emergency are described in Q11 and Q12 of this guidance. When handwritten methods are used, the sponsor 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 72 Available on the FDA guidance web page. 73 Available on the FDA guidance web page. 74 For the purposes of this guidance, the term electronic systems means systems, including hardware and software, that produce electronic records. 75 For the purposes of this guidance, the term electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature (21 CFR 11.3(b)(7)). 76 See 21 CFR 11.1(b). See also the guidance for industry Part 11, Electronic Records; Electronic Signatures— Scope and Application (August 2003), available on the FDA guidance web page. 77 For records that are not subject to Part 11, sponsors and other regulated entities should rely on their internal business practices to determine acceptable electronic signature methods and controls. 78 Available on the FDA guidance web page. 79 Available on the FDA guidance web page. When final, this guidance will represent FDA’s current thinking on this topic. 80 See 21 CFR 11.3(b)(8) for the definition of a handwritten signature. Contains Nonbinding Recommendations 35 electronic copies (e.g., using a validated process for scanning paper copies), and (2) retained according to applicable FDA record retention requirements.81 Q27. Certain clinical trial protocols have an exclusion criterion for receipt of another “investigational medical product.” If a participant receives a vaccine or other medical product for the prevention or treatment of COVID-19 authorized under an Emergency Use Authorization (EUA), would FDA consider this receipt of an investigational medical product? When a medical product is being used under an EUA, it is an authorized (though not an approved or cleared) medical product for use in clinical care that has met the statutory criteria under section 564 of the FD&C Act. The product is not being studied under an IND or IDE when used pursuant to an EUA, and FDA therefore does not consider receipt under an EUA as receipt of an investigational product.82 In contrast, when the same product is used in a clinical investigation under an IND or IDE, the product’s safety and/or effectiveness is being studied for investigational uses, and FDA would consider receipt in this situation to be receipt of an investigational product. As always in the design of a clinical investigation, there may be valid scientific reasons to have an exclusion (and even a discontinuation) criterion for a medical product—a monoclonal antibody or vaccine, for example—whether that product was used under an EUA or not. These scientific reasons may include risks to an individual if they enroll or continue to participate in a clinical trial after receiving (or having received) the excluded product, or the potential impact of the use of the excluded product on trial objectives, such as confounding the determination of effectiveness of the product under investigation. 81 See 21 CFR 312.57, 312.62, and 812.140. 82 See guidance for industry Emergency Use Authorization of Medical Products and Related Authorities (January 2017), available on the FDA guidance web page. Contains Nonbinding Recommendations 36 Q28. During the COVID-19 public health emergency some sponsors have used remote monitoring to oversee study conduct at clinical trial sites, including remote review of source data. Should data that have been remotely monitored be re-monitored during an on-site monitoring visit once pandemic-related restrictions that prevented on-site monitoring visits have been lifted?  FDA regulations require sponsors to monitor the conduct and progress of their clinical investigations. 83 These regulations are not specific about how sponsors must conduct such 

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