Nih regulatory binder template
WebbAdverse Event Forms [24KB Word file]. Baseline Visit Checklist [32KB Word file]. Delegation of Authority Log [1.1MB Word file]. Demographics Form [33KB Word file]. Documentation of Informed Consent Summary Sheet & Template [1MB Word file]. Essential Regulatory Docs Guidance and Binder Tabs [4.5MB Word file]. FDA … WebbA Regulatory Binder will be maintained at each study site and serves as the central source for essential document (ED) maintenance at the site. EDs for this trial will be …
Nih regulatory binder template
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WebbEach section outlines the regulatory documentation requirements, general guidance for organization and record keeping, and, when applicable, references to federal regulations and Good Clinical Practice guidelines. General Guidance for using the Regulatory Binder • These Regulatory Binder tabs should serve as a template. It is important to note Webbdocuments, and any revisions to the documents should be retained in the regulatory binder. Examples of documents requiring IRB approval and documents that must be ...
WebbThis toolkit of materials contains templates, sample forms and information materials to assist clinical investigators in the development and conduct of high-quality clinical … WebbA regulatory binder is a central organized file (can be paper or electronic or both) that houses documents pertaining to the conduct of the study (e.g., Institutional Review …
WebbTemplate Documents. These template documents are meant to serve as a guide for preparation of regulatory submissions to the FDA. Additional regulatory tools and educational resources for academic researchers are available on the ReGARDD website. Please note that all Duke-sponsored regulatory submissions to the FDA (or other … WebbThe Regulatory Binder is a template and guidance document for tracking documentation associated with studies involving human subjects. It is designed to help study sites achieve and maintain regulatory compliance and adhere to high standards of practice in the conduct of research involving human subjects.
Webb7 sep. 2024 · The REDCap eRegulatory Binder Template provides a structure for essential record collection and retention. This template is intended for IRB approved research studies and should follow your organizations SOPs. Guidelines for use of the binder: Title of the binder with the PI name, study short title, and IRB assigned number.
WebbThis template assists the principal investigator and study team in fulfilling their responsibilities regarding study close-out when all study activities are terminated. … goldchanceWebbThey also work with investigators on the development of regulatory binders and case report forms at the time of new protocol initiation. The Standards for Clinical Research within the NIH Intramural Research Program, implemented in January 2000 by the Clinical Center Medical Executive Committee, establish minimum requirements for the conduct … gold chanceWebbAdditionally NIH provides a regulatory binder checklist. Harvard Catalyst provides a template for a regulatory binder. The Project Director should be responsible for the … hc-a-l03