Consent letter google docs survey12/28/2023 ![]() ![]() DocuSign–You may request a Part 11 Compliant version of DocuSign by going to the DocuSign wiki page and clicking on request additional roles.On a going forward basis, the most appropriate way to handle eConsent is by using DocuSign. Part 11 compliance requires many steps and validation on a per study basis that would not be feasible at this time. REDCap – We have received updated guidance that REDCap is not Part 11 compliant for FDA regulated studies under any circumstance. When conducting consent electronically, participant identity verification is required. USC has a Part 11 Compliant version of DocuSign that may be used for consent and HIPAA authorization. For FDA regulated studies, REDCap may not be used to obtain consent or HIPAA authorization. Make sure you document the consent process so that anyone examining your approach will be able to see how consent was obtained in good faith. In the event your participant population cannot access DocuSign or another secure and encrypted online platform (e.g., REDCap), you may consider having participants take photographs of their signed consents using their cell phones and emailing them to the study team. You may obtain HIPAA authorization electronically using DocuSign or REDCap for all studies, irrespective of risk level. In general, consent may be obtained electronically using DocuSign or REDCap. Description and Risks of Common Medical Procedures.Please email your request to: assistance call: (213) 740-5857 USC has approved suppliers/vendors (translation services). ![]() Minimal risk studies (Exempt or Expedited) do not require a CoT to be submitted. A letter of IRB approval will not be issued for the translated consent document. Investigators will receive email notification that the translated consent form is ready for use. The translated ICF and appropriate documentation must be sent to the IRB via “Send Message to IRB.” The translated consent form with IRB stamp will be uploaded into the iStar application. For studies that are greater than minimal risk (Full Board), one of the following is required a) A Certificate of Translation (CoT) by a professional certified translator/translation company, or b) documentation that the translation has undergone quality review by an entity such as an NIH Regulatory Support Center or the NIH Translation Unit. It is the responsibility of the investigator or study sponsor to provide translation of an IRB approved Informed Consent Form (ICF). Includes the essential elements of consent, instructions for use, the California Subjects Bill of Rights, conflict of interest requirements, considerations for long term specimen use and other institutional requirements. This document must be utilized for projects with Expedited or Full Committee review when there is no consent form from an industry sponsor or cooperative group. The iStar submission must include an electronic version of the study’s consent template and the consent version that includes all USC specific modifications for review. Consent forms provided by an industry sponsor, cooperative group, or external IRB need to be modified only to include the addition of USC specific requirements, such as local contact information, cost/injury, payment language and removal of HIPAA. The IRB accepts all industry sponsored consent forms with minimal change in content.
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