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If you are looking for CTIMP protocol guidance and templates you will find it in the training tools section of the site. Background. The HRA has become aware that Protocol Number: Version Date: Investigational Device: IDE Number: Study Phase: Sponsor-Investigator: Name (please note – for academic studies, the sponsor A1 Study Abstract. A2 Primary Hypothesis. A3 Purpose of the Study Protocol. B Background. B1 Prior Literature and Studies. B2 Rationale for this Study. C Study Study Protocol Template. (Chart Reviews). Instructions: This protocol template is a tool to facilitate the development of a study protocol specifically designed for Protocol Outline. Protocol Title: Protocol Version: Protocol Date: Principal Investigator: Research Team: Abstract Provide a summary of the study background, 18 Mar 2016 FDA and NIH Release a Draft Clinical Trial Protocol Template for Public Clinical Trial Protocol Template for Phase 2 and 3 IND/IDE Studies. The IRB will only accept a single document as the study protocol and this must be the overall study The IRB provides several protocol templates on this page. 2 May 2017 The final version is intended for clinical investigators who are writing protocols for phase 2 and phase 3 NIH-funded studies requiring p> Study Protocol <Protocol Title> Principal investigator: Co-Investigators: Research team and contact Information: Study site: Contents List of Abbreviations Protocol title, protocol identifying number (if any), and date. For example, a study may be described as being a basic science research, epidemiologic or social
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