![]() ![]() Regulations require that the person signing the informed consent be given a copy of the informed consent form, which can be done through participant portal access in Florence eConsent, or by downloading the consent form and providing a paper copy. Clinical staff are able to manage consent form versions within the clinical portal, and only active forms can be sent to participants. I f an Electronic Record is changed or modified, appropriate version controls are in place to ensure the changes do not obscure previously recorded information. Forms stored within Florence eConsent meet the fundamental principles of data quality as outlined in ALCOA-C and ALCOA++ standards. OHRP and FDA regulations allow the use of electronic and paper informed consent methods independently or in combination, allowing the flexibility to use the consent workflow that is best for the participant when their consent is being obtained.įlorence’s 21 CFR Part 11 compliance controls ensure that all forms uploaded into the system can be considered trustworthy, reliable, and generally equivalent to paper records. If a participant signed a paper form during their visit, users can also upload a scanned version of the form to Florence eConsent and utilize the certified copy feature to document the copy has the same information as the original version, in alignment with requirements for certified copies. Interpreters may be assigned to support consenting non-English speaking subjects as confirmation that all information was provided in the participant’s language.Parental permission may be obtained and documented for pediatric participants.Legally Authorized Representatives (LARs) can be assigned to study participants who cannot consent for themselves.When routing a consent form, clinical staff are able to assign additional signers similar to paper consenting workflows. In 2016, the FDA posted a Guidance on the Use of Electronic Informed Consent, providing recommendations on the use of electronic systems to obtain informed consent.įlorence eConsent is compliant with all technical requirements of 21 CFR Part 11 is compatible with the requirements outlined in 21 CFR parts 50 and 56, and 45 CFR Part 46 and fully conforms with the FDA’s Guidance on the Use of Electronic Informed Consent, along with other guidance documents that FDA has in place surrounding Part 11.įlorence eConsent enables users to upload consent forms directly into the system for ease of use, allowing participants to review consent forms at their own pace and ask questions prior to signing via a compliant signature. When utilizing electronic informed consent, FDA’s 21 CFR Part 11 sits on top of these regulations, outlining additional requirements specifically for electronic records and electronic signatures. In the US, requirements for the general consent process are outlined in 21 CFR parts 50 and 56 for FDA regulated studies, along with HHS requirements set forth in 45 CFR part 46. Florence eConsent enables users to take the traditional wet-ink consent process electronically, opening the door to remote consent workflows and more.
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