2017年9月29日 · A Note to File provides way to describe and document deviations, problems, or events occurring during the conduct of research which cannot be documented in a standard case report (CRF) form or research record.

NIMH Note to File (NTF) Template [Word] This document provides a sample template for generating notes-to-file, which are written to acknowledge a discrepancy or problem with the study’s conduct, or for other administrative purposes …

This file provides a template for creating a Note to File, including specific guidelines and a sample note. It ensures compliance with documentation standards. Essential for research coordinators and clinical trial teams.

This template can be used to document various events or issues that occur throughout the course of a research study. Related Research Topics PI Temporary Leave/Sabbatical, etc.

Note to File Template (MS Word, 20K) – Used by clinical site staff to document protocol deviations or other discrepancies identified during the conduct of the clinical research study and plans for resolution/prevention.

Title: Microsoft Word - 2017.09.29 Creating a Note to File Author: MLeary Created Date: 10/28/2020 12:51:35 PM

If the issue relates to site performance, the appropriate credentialed individual from the site should write and sign the note to file. If the issue relates to PI responsibilities (e.g., human subject protection, data integrity at the site), the PI should write and sign the note to file.

A Note-to-File gives explanation to the conduct within a research trial. It is used to clarify an error, omission or discrepancy or to document a problem or corrective action.

Note to File. Page . 2. of . 2. D: ate: [Insert date of the ; n; ote to file (NTF)] Clinical Research Site. Number: Principal Investigator/ Investigator of Record: Protocol Number, Version and Date: RE: [insert a brief description of the subject of the . NTF] Author: DAIDS Created Date: 12/16/2020 10:30:00 Title: SCORE Manual Appendix Note to ...

DMID Notes to the Study File Guideline & Template 9 July 2021 Page 2 of 3 Format and Content The NTF should be written on institutional letterhead and include the following elements.