WebOARC office email: [email protected] Phone: 919-613-7630. Duke Health Integrity Line and Duke Speak Up Program - (800) 826-8109. Speak Up Online Form: Anonymous Form. … WebDUHS IRB Office Suite 900 Erwin Square 2200 West Main Street Campus Box # 104026 Durham, NC 27705. Phone: (919) 668-5111
eRegulatory Binder Checklist: What Does the FDA …
WebOrganize Your Study: Study & Subject Binders Complete and thorough protocol documentation generally includes a Study Regulatory Binder, in which all study related documents and correspondence are stored, and individual Subject Case Histories, in which subject specific documents are maintained.. Developing and Maintaining the Study … Regulatory binders contain most of the essential study documents in an organized and readily-retrievable format. A table of contents is highly recommended. Note that it is acceptable to include specific information regarding the location of these essential documents if they are electronic and/or … See more You should keep separate files with information on each of your study subjects. Source documents should be kept in subject files … See more When something unusual or unexpected occurs, you should create a “note to file” to explain the situation (who, what, where, when, why, how) and … See more intrinsic vs extrinsic options
Regulatory Binder - Clinical Research Operations Office
Webdocuments as a part of your site regulatory file, the following guidelines should be observed: o Either a) place an NTF in the relevant location of the binder that directs an individual to the electronic location - OR- b) place a paper placeholder in one location in the binder that includes a list of all documents that are stored only WebThe regulatory binder may be maintained with hard copies in a physical binder, or electronically as a regulatory file. Where hard copy documentation is not maintained within the regulatory binder, include a signed and dated note-to-file within the binder indicating where documentation is physically stored, who is responsible for the documentation, and … WebOrganizing Your Regulatory Binder. Instructions: Create tabs for each section listed below and place the appropriate documents in each corresponding section in a binder. Be sure to label the outside of the binder (cover and spine) with the protocol number, PI … intrinsic vs extrinsic mri