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It explains the site visit process flow, including steps before, during, and after visits, as well as how to mark subjects to be monitored and document site visits through trip reports. The guide details trip reporting workflows, approval cycles, protocol deviation handling, follow-up activities, and tracking for ICF and CRF, including exporting and importing trip reports via Excel and generating PDF versions. 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The product names and services are used throughout this document in editorial fashion only and for the benefit of such companies. No such use, or the use of any trade name, is intended to convey endorsement or other affiliation with the document.  \nCopyright Notice  \nCopyright © 2014 by Information Technology Training & Documentation at Duke Clinical Research Institute. All rights reserved.  \nPrinted in the United States of America. This publication, or any part thereof, may not be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, storage in an information retrieval system, or otherwise, without the prior written permission of Duke Clinical Research Institute.  \nVersion  \nRevision Level 9 • Published July 2014  \nCONTENTS  \nReference Guide Conventions ........................................... vii  \nWhat You Need to Know Before Using This Reference Guide................ vii  \nVisual Aids Used in This Reference Guide............................................... vii  \nSite Monitoring Overview ..................................................... 9  \nProtocol-Specific Options ..........................................................................10  \nSite Visits: How Often?.............................................................................. 10  \nSite Visit Process Flow .............................................................................. 11  \nBefore the Site Visit............................................................................. 11  \nDuring/After the Site Visit...................................................................12  \nMarking Subjects to be Monitored..................................... 13  \nMarking Subjects ....................................................................................... 13  \nDocumenting a Site Visit .................................................... 15  \nCreating a Site Visit Record.......................................................................16  \nCompleting Fields After Trip Report Approval .........................................23  \nAdding Data to Fields After Trip Report Approval .............................23  \nViewing the Trip Report Status History.....................................................25  \nTrip Reporting ...................................................................... 27  \nStarting a New Trip Report ........................................................................28  \nChanging the Report Template ............................................................30  \nCreating a Confirmation Letter ..................................................................31  \nCompleting the Trip Report .......................................................................35  \nForm Fields..........................................................................................35  \nChecklist Activities..............................................................................39  \nFollow-Up Activities ...........................................................................42  \nICF Tracking........................................................................................45  \nCRF Tracking ......................................................................................47  \nRev 9-July 2014  \nProtocol Deviations .................................................................","cbCaintGDIznnKOo","https://ap.wps.com/l/cbCaintGDIznnKOo","pdf",1346843,76,"English","# Site Monitoring Overview\n## Protocol-Specific Options\n## Site Visits: How Often?\n## Site Visit Process Flow\n## Marking Subjects to be Monitored\n## Documenting a Site Visit\n# Trip Reporting\n## Starting a New Trip Report\n## Changing the Report Template\n## Creating a Confirmation Letter\n## Completing the Trip Report\n## Form Fields\n## Checklist Activities\n## Follow-Up Activities\n## ICF Tracking\n## CRF Tracking\n# Protocol Deviations\n## Attachments\n## Creating a Follow-Up Letter\n# Working with the Offline Trip Report\n## Key Points for Exporting\n## Exporting a CTMS Trip Report to Excel\n## Key Points for Importing\n## Importing a Trip Report from Excel Back to the CTMS\n# Trip Report Approval Process\n## Submitting a Trip Report for Approval\n## Approving a Trip Report\n## Returning a Trip Report to the CRA for Editing\n## Viewing and Creating a PDF Trip Report\n# Viewing Site Visit Metrics\n## Logging Conversations\n## Viewing All Conversation Logs\n# Appendix A: Trip Report\n# Appendix B: Attachments","[{\"question\":\"What does the site monitoring guide explain before starting site visits?\",\"answer\":\"It outlines reference guide conventions and covers what to know before using the guide, then provides a site monitoring overview and protocol-specific options, including how often site visits occur and the overall process flow.\"},{\"question\":\"How are trip reports created and maintained during trip reporting?\",\"answer\":\"The guide describes starting a new trip report, changing the report template, creating a confirmation letter, and completing trip report content, including form fields, checklist activities, follow-up activities, and ICF/CRF tracking.\"},{\"question\":\"What steps are involved in exporting, importing, and approving CTMS trip reports?\",\"answer\":\"It covers exporting a trip report to Excel, entering data in the exported report, importing the report back into CTMS, and then following the trip report approval process, including submitting, approving, returning for CRA edits, and generating PDF trip reports.\"}]","CTMS Site Monitoring - User Reference Guide | PDF",1789130715,27]