Duke regulatory binder checklist
WebPurpose. Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of Good Clinical Practice and all applicable regulatory requirements. 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 …
Duke regulatory binder checklist
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WebFeb 8, 2024 · placed in the study’s regulatory binder. o When an undergraduate student is added to a study protocol as Key Personnel, the original application or personnel amendment must include the name of the Duke Faculty/staff member who will train the student on conducting the study-specific consent process. This Duke WebNIMH Regulatory Document Checklist for Human Subjects Research Clinical Trials with Investigational Product not under a FDA IND/IDE [Word] ... This log is typically reviewed at all subject study visits and is located in each participant’s study binder. NIMH Research Sample Inventory/Tracking Log [Word]
WebThe policies of Duke University apply to all components of Duke, including Duke University Health System, and govern the pursuit of Duke's missions - education, research and … WebJun 26, 2024 · an SOP on regulatory binder/file management that is specific to this question. An SOP on regulatory binder/file maintenance should address the following: o Required documents o Location of various components of the regulatory documentation when study is on-going o Frequency and responsibility for updating the regulatory …
WebStep 5: Ensure that the Regulatory Binder is part of your routine self-monitoring, and that the records are made accessible to any internal or external monitor, University administrators, the IRB, and any applicable regulatory agency. Step 6: Record Retention - study records and essential documents must be retained for the WebJul 17, 2015 · National Institutes of Health
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
WebJul 17, 2015 · Regulatory Binder Checklist Version 3.0 1 of 4 12May2014 ; Regulatory Binder Checklist The following documents (all versions) should be collected and filed in … charlotte beer fest ticketsWebICH GCP Essential Document Checklist _____ _____ _____ Regulatory contact signature Initial review date Pre-activation ... Usual Regulatory Binder Items: Location of Document (if/when applicable) date: Regulation Section Number . Document . Not Applicable : Regulatory Binder . Coordinator Manual : charlotte beer and wine festivalWebRegulatory Binder Contents Checklist If the sponsor doesn’t provide you with a regulatory binder, you should put one together and include the following documents. This binder will be convenient for reference and for monitoring visits and audits. Please note that you should not put any contractual or fi nancial information in the regulatory ... charlotte beers at ogilvy \\u0026 mather worldwideWebRegulatory Binders. Regulatory Records Checklist Template; Adverse Event Tracking Log Template; Delegation of Responsibilities and Signature Log Template; Financial Interest Disclosure Form Templates; Monitoring Visit Summary Log Templates; Regulatory Binder Protocol Deviation Log Template; Regulatory Binder Note to File Templates charlotte beers at ogilvy \u0026 mather worldwideWebRegulatory Binder Checklist Version 3.0 2 of 4 12May2014 Regulatory Binder Checklist The following documents (all versions) should be collected and filed in the regulatory binder, if applicable to the clinical study (ref: ICH/GCP). Protocol and Amendments Log of protocol changes charlotte beerfestRegulatory 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 charlotte bed \u0026 breakfastWebRegulatory Binder Checklist- Page 3 of 4 SCREENING / ENROLLMENT DOCUMENTS ☐ Screening and Enrollment Log, without identifying information ☐ Subject Identification … charlotte beer festivals 2023