CTMS Site Monitoring - User Reference Guide

Sep 11, 2026

CTMS Site Monitoring User Reference Guide provides practical guidance for conducting site monitoring activities within a clinical research environment. 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. It also covers attachments, metrics, and conversation logging, supported by reference conventions and appendices.

LanguageEnglish

CategoryPresentations

FormatPDF

Pages76

Reading Time27 min

AccessFree to download

Site Monitoring Overview

Protocol-Specific Options

Site Visits: How Often?

Site Visit Process Flow

Marking Subjects to be Monitored

Documenting a Site Visit

Trip Reporting

Starting a New Trip Report

Changing the Report Template

Creating a Confirmation Letter

Completing the Trip Report

Form Fields

Checklist Activities

Follow-Up Activities

ICF Tracking

CRF Tracking

Protocol Deviations

Attachments

Creating a Follow-Up Letter

Working with the Offline Trip Report

Key Points for Exporting

Exporting a CTMS Trip Report to Excel

Key Points for Importing

Importing a Trip Report from Excel Back to the CTMS

Trip Report Approval Process

Submitting a Trip Report for Approval

Approving a Trip Report

Returning a Trip Report to the CRA for Editing

Viewing and Creating a PDF Trip Report

Viewing Site Visit Metrics

Logging Conversations

Viewing All Conversation Logs

Appendix A: Trip Report

Appendix B: Attachments

July 2014 CTMS Site Monitoring User Reference Guide Trademarks DCRI is a registered trademark of Duke University. Siebel is a registered trademark of Siebel Systems, Incorporated. Microsoft, Excel, Outlook, Windows, and Word are registered trademarks of the Microsoft Corporation in the United States and other countries. Adobe and Acrobat are registered trademarks of Adobe Systems Incorporated in the United States and other countries. All other product names and services used throughout this document are trademarks or registered trademarks oftheir respective companies. 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. Copyright Notice Copyright © 2014 by Information Technology Training & Documentation at Duke Clinical Research Institute. All rights reserved. Printed 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. Version Revision Level 9 • Published July 2014 CONTENTS Reference Guide Conventions ........................................... vii What You Need to Know Before Using This Reference Guide................ vii Visual Aids Used in This Reference Guide............................................... vii Site Monitoring Overview ..................................................... 9 Protocol-Speciﬁc Options ..........................................................................10 Site Visits: How Often?.............................................................................. 10 Site Visit Process Flow .............................................................................. 11 Before the Site Visit............................................................................. 11 During/After the Site Visit...................................................................12 Marking Subjects to be Monitored..................................... 13 Marking Subjects ....................................................................................... 13 Documenting a Site Visit .................................................... 15 Creating a Site Visit Record.......................................................................16 Completing Fields After Trip Report Approval .........................................23 Adding Data to Fields After Trip Report Approval .............................23 Viewing the Trip Report Status History.....................................................25 Trip Reporting ...................................................................... 27 Starting a New Trip Report ........................................................................28 Changing the Report Template ............................................................30 Creating a Conﬁrmation Letter ..................................................................31 Completing the Trip Report .......................................................................35 Form Fields..........................................................................................35 Checklist Activities..............................................................................39 Follow-Up Activities ...........................................................................42 ICF Tracking........................................................................................45 CRF Tracking ......................................................................................47 Rev 9-July 2014 Protocol Deviations .................................................................

FAQs

What does the site monitoring guide explain before starting site visits?

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.

How are trip reports created and maintained during trip reporting?

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.

What steps are involved in exporting, importing, and approving CTMS trip reports?

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.

Sep 11, 2026

Uploaded by River Wang