what does electronic subject notification mean

For example, some subjects may prefer one method over another. Thus, System institutions cannot use electronic notification to deliver some notices that must be provided under part 617, subparts A, D, E, and G of this chapter. The law also requires paper notification to cancel or terminate life insurance. Any information sent by SMS should be readily actionable in a short timeframe. In general, the statute bars wiretapping and electronic eavesdropping, possession of wiretapping or electronic eavesdropping equipment, and the use or disclosure of information unlawfully . Employees use the Web portal to add individual contact information to the database, including phone numbers. Therefore, the IRB must review and approve the eIC and any amendments to the eIC that the subject will receive and view (see 45 CFR 46.109(a) and 21 CFR 56.109(a)). The investigator should submit to the IRB copies of all forms (electronic and paper forms) and informational materials, including any videos and Web-based presentations, which the subject will receive and view during the eIC process. 0000003303 00000 n Unless exempt, introducing a device into commercial distribution (marketing) for the first time. Using Electronic Means to Distribute Certain Product Information For the purposes of this guidance, electronic informed consent refers to the use of electronic systems and processes that may employ multiple electronic media, including text, graphics, audio, video, podcasts, passive and interactive Web sites, biological recognition devices, and card readers, to convey information related to the study and to obtain and document informed consent. 0000112594 00000 n . endstream endobj 30 0 obj <> endobj 31 0 obj <> endobj 32 0 obj <>/ProcSet[/PDF/Text]>>/Rotate 0/StructParents 0/TrimBox[0.0 0.0 612.0 792.0]/Type/Page>> endobj 33 0 obj <> endobj 34 0 obj <> endobj 35 0 obj <>stream

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