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Regulatory binder documents include the following: 1. Study Administrative File Table of Contents 2. Study Administrative File Drug Study Table of Contents 3. Study Administrative File Device Study Table of Contents 4. Template for Protocol Training Tracking See more Protocol Builder is a first-of-its-kind solution that makes writing investigator-initiated protocols faster and easier, and helps to ensure that … See more You may need one or several of the following forms as you obtain informed consent or assent from subjects. Key Information Template (new rule)Biomedical Consent Form Template (old rule) (new … See more You may find the following guidance documents helpful as you create a new protocol and submit to the appropriate review boards. See more When using direct patient contact as a recruitment method, you need to include information in your proposed protocol to the IRB. Once you … See moreWebFor your convenience and to facilitate IRB review, we have developed template study documents that may be used to assist in the development of the proposed protocol and informed consent documents. The templates include the required elements of informed consent according to 21 CFR 50.25, 45 CFR 46.116 and ICH Guidelines.share folder android to pc
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