ICTR therapeutic clinical trial template.For biomedical clinical investigations evaluating drugs and/or devices, the following templates include guidance specific to the FDA requirements: :.The following protocol templates are available to assist you in developing a standalone protocol: See the “Protocol Templates” section for specific guidance, as well as general protocol guidelines. When creating a protocol document for an investigator-initiated study, use a template appropriate to the type of research. If a sponsor or a lead site has provided a protocol document for the study, upload that protocol in the IRB application. This determination would depend on several factors including the board that will review the study (MRR or HS), and the types/number of physical interventions.Īll studies requiring a protocol should be submitted using the protocol-based application (for studies likely to be single site) or the single IRB application (for studies where the UW will be serving as the single IRB for multiple sites) in ARROW. The IRB may require a protocol for some other types of minimal risk research such as those studies involving multiple physical interventions, complex study design, or use of drugs, biologics, nutritional supplements, or devices. This section of the Investigator Manual describes research that requires a standalone protocol. For some of these studies, the IRB requires a standalone protocol that you will upload in the IRB application. Studies that meet the federal definitions of human research require IRB review. The section also provide protocol guidelines. All these features are available to you for free, without any limitations.This section of the Investigator Manual describes research that requires a standalone protocol, including clinical trials, more than minimal risk studies, registry and repository studies, studies requiring scientific review, and non-exempt multi-site studies. You do not need a subscription to manage your files, watch movies, read books, listen to music, download files, connect to a PC, transfer files, etc. The subscription is only required for the professional PDF features and VPN. Learn more about our Terms of Service and Privacy Policy. The subscription renews automatically until you cancel it. The payment will be charged to your iTunes account. You'll be upgraded once you review the subscription terms and confirm the action in the Apple's pop-up message. the functionality that comes as a part of the subscription). Unless you have already upgraded, you'll be offered to start with the Documents Plus subscription every time you try using the VPN or advanced PDF features (i.e. You can also upgrade your plan to get a VPN. Important note for existing subscribers: Those of you who previously subscribed to professional PDF tools in Documents can still benefit from these features on the terms and price you had before.
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