(Personal email addresses may be used on a limited basis for external parties with whom we have a formal business relationship.) Inclusionsĭocuments necessary to support normal clinical research business operations (including research projects).ĭelegations of Authority (DOA) Logs – Allowable Use of a Duke email address is required for employee signatories. Academic or corporate email addresses of collaborators or vendor/sponsor stakeholders are preferred. Use Adobe Sign for operational documents requiring an internal Duke employee signature or a signature from an employee at a collaborating study site or with a vendor/sponsor with whom we have a formal business relationship. For questions, please contact Usage Guidelines and Restrictions The document requires a handwritten signature for teach team member using the Adobe Sign software. Study teams looking for a letter of non-repudiation at the request of a sponsor can find one by clicking on this link. Sharable Documentation:Īdobe Sign An Analysis of Shared Responsibilities for 21 CFR Part 11 and Annex 11 Compliance (non Duke specific) DHTS Policies and SOPs:ĭHTS IT-POL-2333 Adobe Sign Use and Storage PolicyĭHTS IT-SOP-6483 Adobe Sign Settings for Compliance with 21 CFR Part 11 Electronic SignaturesĭHTS IT-SOP-6745 Adobe Sign Use and Template Requirements for 21 CFR Part 11 Compliance Letter of Non-Repudiation Below are two documents that may be provided to sponsors with questions about part 11 compliance. This was determined by DHTS to meet the requirements of an “Electronic Signature” under part 11 as long as we’re working with entities that Duke has a business relationship with. We require the use of Duke/Corporate email addresses that require log in with a network ID, thus validating the signer. Instead, we use the more generic “Electronic Signature”. Register Part 11 Compliance Documentation and DHTS SOPs:ĭHTS’s Adobe Sign instance is not configured for “Digital Signature”, which is a specific type of electronic signature that uses higher-level encryption and requires a third party to certify you are who you say you are for a fee, similar to a notarized signature. Differentiate between e-signatures and digital signatures.Describe how you can and cannot use Adobe Sign.This training is intended for clinical research personnel at Duke who will request access for Adobe Sign from the Duke Office of Clinical Research. Adobe Sign Training for Clinical Research | DOCR | 00147697 When you are ready to use Adobe Sign follow this link to get there. If you need an account, complete the training below and then request one by completing the form found here. In order to create and send documents with Adobe Sign, you will need to have an account. Documents will be permanently purged and recovery will not be possible. This policy will remain in effect in perpetuity. Thirty days after a document is completed (signed by all parties necessary) it will be automatically and permanently purged from the Adobe Sign storage cloud. No software is needed for signers (who can be internal or external to Duke, provided no PHI is being sent).ĭHTS has implemented a 30 day document retention policy effective November 5th, 2020. Use a modern browser to prepare, send, sign, track, and manage signature processes. With the secure Adobe Sign cloud-based app, you replace paper and ink signature processes with fully automated electronic signature workflows.
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