Document Management
Guide
IRMS-5.8.5.0-Document Mgmt Guide.doc
01.0
ii
9018 Heritage Parkway
Suite 600
Woodridge, IL 60517
Phone:
630-243-9810
Fax:
630-243-9811
E-mail:
[email protected]
Web:
http://www.IRMSOnline.com
The information in this document is proprietary. No part of this document may be reproduced or
transmitted in any form or by any means, electronic or mechanical, for any purpose, without the
express written permission of Online Business Applications, Inc.
Information in this document is subject to change without notice. The companies, names, and data
used in examples herein are fictitious unless otherwise noted.
2010 Online Business Applications, Inc. All rights reserved.
This document was produced using Microsoft Word.
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Table of Contents
CHAPTER 1
INTRODUCTION
1
Purpose of this Manual...1
How to Use this Guide ...1
Communicating with Online Business Applications, Inc...3
Browsing our Website ...4
IRMS Support...5
IRMS Education ...7
IRMS Documentation...8
IRMS User Group...9
CHAPTER 2
DOCUMENTS MENU
11
Overview ...11Documents Menu ...12
CHAPTER 3
TYPES OF DOCUMENTS
13
Types of Documents...13 Standard Documents... 14 E-mail Documents... 14 Global Documents... 14 Reference Documents... 15 Product Documents ... 15 Enclosures ... 16 Opening Template ... 17 Closing Template ... 18CHAPTER 4
RESPONSE LETTER MANAGEMENT
19
Understanding How IRMS Constructs a Response Letter...19Letter Formats ... 20
Adding a Letter Format: ... 21
Example Formats for IRMS ...26
Standard Letter ... 26
Cover Letter ... 28
Cover Only ... 29
Standalone ... 31
User Defined Formats ... 32
Template Control...33
Understanding the Process IRMS uses to Select a Template: ...34
Adding a Template Control Record:... 34
Images Control ...36
Adding Images to a Response Letter... 36
Examples of the Image Screen in Use ...39
Disclaimer Example ... 39
Letterhead Example:... 40
Signature Example: ... 41
CHAPTER 5
BUILDING A DOCUMENT REPOSITORY
43
Document Maintenance Window ...43Building Templates ...47
Adding an Opening Template ... 47
Adding a Closing Template... 50
Creating Standard Documents ...52
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Creating Product Documents...58
Creating Enclosure Documents ...59
Creating E-mail Templates...61
Additional Features with Documents ...63
Establishing Notification of Expired Documents ... 63
Printing/Viewing an “Enclosures Where Used” Report ... 64
Adding a Local Standard Document from a Global Document ... 65
Linking Standards ... 67
Auto-formation of Bullet Text... 67
Creating a Combo Document to a Document Repository... 68
Modifying a Document ... 69
Copying the Current Document Record ... 70
Deleting the Current Document Record ... 70
CHAPTER 6
MEDICAL INFORMATION COPYRIGHT INTERFACE (MICI)
71
Initial Set Up for MICI ...72IRMS System Parameters... 72
IRMS Document Maintenance ... 74
MICI Menu Bar ...77
The File Menu ... 77
The Tools Menu ... 77
The Help Menu... 77
MICI Tools Menu Options ...78
MICI Connection Setup... 78
MICI Preferences – Copyright Clearance Center Account... 81
MICI – Copyright Submission – Main Menu...83
Build Usage... 83
View / Transfer Usage... 85
View Log... 87
Exit MICI – Main Menu... 88
MICI Reporting ...89
MICI Queue – Currently Queued ... 89
MICI Submission – Complete – Between Dates ... 90
MICI Submission – All – Between Dates... 91
CHAPTER 7
INTRODUCTION TO WORKFLOW PROCESSES
93
Overview ...94System Parameters ...95
Division Parameters...96
Group Security ...97
CHAPTER 8
WORKFLOW PROCESSES
99
Overview ...99Step 1 – Change Approved Document to Pending ...100
Step 2 – Define the Workflow...101
Step 3 – Assign Tasks...104
Step 4 – Complete the Task...107
Step 5 – Record Activity for the Task ...108
Step 6 – Complete the Workflow Process ...110
Step 7 – Change Pending Document to Approved ...111
View and Access Workflow and Workflow Tasks...112
CHAPTER 9
IMPORTING AND EXPORTING DOCUMENTS
115
Importing...115Importing a Document in Document Maintenance... 115
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Importing with a Specification File ... 119
Importing Enclosures using Import Wizard... 123
Exporting Documents...127
CHAPTER 10
MERGE FIELDS FOR DOCUMENT IMAGES
131
Merge Fields for Document - Images... 131CHAPTER 11
OTHER DOCUMENT MGMT OPTIONS
133
Document Log...133Sample Document ...134
Printing a Sample Document... 134
Seeing New Data ...135
Resetting Security ... 135
Refreshing Table Values (Updating Combo Box Selections)... 135
CHAPTER 12
FIELD DEFINITIONS AND TOOLBARS
137
Document Maintenance Field Definitions...137Document Maintenance Screen Toolbar ...141
CHAPTER 13
APPENDIX
143
Flowchart – Workflow Process ...144Quick Reference Sheet – Workflow Process...145
CHAPTER 14
INDEX
147
REVISION HISTORY...149Chapter 1 Introduction
Welcome to IRMSNow that you have implemented the Information Request Management System (IRMS) from Online Business Applications, Inc. (OBA) for medical communications solution, it’s time to create the Document Repository that will be used in Case Entry. This guide describes how to setup and maintain the Document Repository along with defining Letter Formats, Template Control, using the Medical Information Copyright Interface (MICI).
Purpose of this Manual
The purpose of this guide is to explain how to setup a Document Repository, Template Control, and Letter Formats. This includes the various types of documents available with IRMS. In addition, the Copyright Interface feature is explained.
This manual is intended for teams that develop and write standard documents, product documents, reference documents. e-mails, and templates or use the Response Letter screen in Case Entry.
How to Use this Guide
What this guide includesThis guide includes the documentation needed to efficiently develop, maintain, and use documents throughout the IRMS application.
How this guide is setup
Each chapter in this guide provides information on using a specific feature related to document management. Chapter 1 provides an introduction to IRMS and this guide.
Chapter 2 Document Menu provides and overview of the options available on the Documents Menu. Chapter 3 – Type of Documents reviews the different documents that are used in IRMS with an example of each document type. Standard Documents and Templates are included.
Chapter 4 –Response Letter Management explains how to construct a Response Letter and use
Template Control. Examples of different formats is provided.
Chapter 5 – Building a Document Repository describes how to use the Document Maintenance to
create and maintain standard, reference, and product documents, enclosures, and templates.
Chapter 6 – Medical Information Copyright Interface explains how to use the Copyright Interface
module for enclosures with the Copyright Clearance Center. The process includes setup, the MICI Main Menu, and reporting.
Chapter 7 – Introduction to Workflow Processes explains how the Workflow Process works in
IRMS. Topics include an overview of the process and how to setup System Parameters, Division Parameters, and Group Security.
Chapter 8 – Workflow Processes reviews how to setup a workflow, assign tasks, record activity, and
complete the workflow process. Topics also includes how and where to view workflow information.
Chapter 9 – Importing and Exporting Documents reviews how to import documents from other
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Chapter 10 – Merge and Replacement Fields describes how to use these fields with the Document
Repository. In addition, a list of the available fields for merges and replacements are listed.
Chapter 11 – Other Document Options review other options not included elsewhere in the guide.
The sections includes Document Logs and Viewing New Data. A sample document is also provided.
Chapter 12 – Field Definitions and Toolbars provides a definition of the fields on the Document
Maintenance screen. In addition, the options on the Document Maintenance toolbar are reviewed.
Chapter 13 – Appendix provides a Workflow Process Flowchart and a Workflow Quick Reference
Sheet.
Chapter 14 – Index provides a listing of the topics discussed in the guide.
Key to the Guide:
Explanation of data field
Explanation of Checkbox Explanation of Radio Button
Explanation of Command Button
Recommendation from OBA
Important Information – Please Read
Make a Note Additional information is explained here.
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Communicating with Online Business Applications, Inc.
Via Phone
Account Management (630) 243-9810 ext 215.
Sales (630) 243-9810 ext 209.
Technical Support (630) 243-9810 extension 250.
Support Team Hours – 8:00 AM to 6:00 PM US Central Standard Time. Training (630) 243-9810 ext 218.
Via Website
Our website is www.IRMSOnline.com. To contact us from our website, go to the Quick Links
section on the Home page and click Email Support or Email Sales.
Visit our website for information on new releases, documentation, training, the IRMS User Group, and the latest information at Online Business Applications, Inc.
Via E-mail
E-mail us at [email protected].
Via Fax
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Browsing our Website
Our website at www.IRMSOnline.com contains the latest information on OBA and IRMS.
Everything from information on our products, news articles on the latest workshops, current and previous newsletters, registration for training classes and workshops, to User Group information is available. This is the place with the latest updates on new IRMS releases, education, and
documentation.
We are creating a new User Center with IRMS Knowledge Base Articles, Tips & Tricks, FAQ’s, Client Workshop Presentations, and Focus Group Results. It should be available soon on the website.
Information on the latest version of IRMS
The Support menu provides information about new features and functionality added to IRMS. Information for previous versions is also available here. From the Support menu, click Release Notes or Documentation. The following information is available.
Release Notes View the latest release notes to find out what’s changed in IRMS. Release Notes for previous versions are also found here.
Release Documents View the latest documents for a release. The set of documents for a new version includes User Requirement Specifications, Functional Specifications, Upgrade Instructions, and Deployment Plans. Documentation Guides View the guides for current and previous releases of IRMS. In 2006
OBA began releasing documentation for each major release.
Information on IRMS Education
The Services menu provides information about training courses and training class availability. From the Service menu, click Education. The following information is available.
Course Descriptions View the latest courses offered to efficiently operate IRMS. Training Classes Find out when and what training courses are offered at the IRMS
Education Center in Lemont, Illinois.
Training Packet Download a Training Packet containing all the information needed to select and schedule a training class at the OBA Education Center. You can also register for classes online.
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IRMS Support
The Support Team answers questions and responds to problems encountered in IRMS. Important information about our Support Team is listed below.
Contacting the Support Team
Support Team Hours: Monday through Friday
8:00 AM to 6:00 PM US Central Standard Time Phone: (630) 243-9810 extension 250
Email: [email protected]
How the Support Team Works
When a call is received by the Support Team it is logged into a Support Database. At this time a case number and priority is assigned. The case is assigned to a member of the Support Team.
The question or problem is investigated by the Support Team. During the investigation the Support Team may request additional information. This may include additional questions, screen prints, and reports. If a problem cannot be resolved quickly, sometimes a workaround is provided until the problem can be fixed.
If the problem is not resolved in a reasonable amount of time, the problem is escalated to the next level of support. The Support Team member assigned to the case will provide periodic updates on the status of the problem and call with a resolution or workaround.
Reporting a Problem to Online Business Applications
It is important to notify OBA of problems. Any information provided (screen name, action being taken, etc.) will help to eliminate these issues in future releases of IRMS. Serious problems affecting the operation of IRMS will be addressed as soon as possible.
The Best Way to Report a Problem
When problems are found in IRMS, they should be reported to the Support Team at OBA with as much detail as possible. Below is a list of information that may be requested to aid in resolving problems. Additional information may be requested after contacting our Support Team.
Provide a screen printout (if needed)
A screen can be captured by executing the following steps:
1. Move the error message so any important information can be seen in the screen capture. 2. With the error displayed on the screen, press the Print Screen key located on the top row of
the keyboard.
3. Activate Microsoft Word and start a new document.
4. Perform a Paste. (Point to Edit from the menu bar and click Paste from the options presented.)
5. Print the screen to fax to OBA. Provide details on the process being executed. For example, what was clicked and data that was entered.
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6. If manually faxing a screen print, fax it to 630-243-9811. If electronically faxing or e-mailing, save the document to a file to be attached to the message or use File Send to
Provide a report sample (if needed)
If there is a problem with a report, a report sample will be requested by the Support Team. If providing a report in error, follow the steps below to send the report to OBA:
1. Email the report as a PDF. Provide the Report Type and Criteria. Provide any other details about how the report was printed, what options were selected, and what parameters were
entered. Email the report to [email protected].
2. If manually faxing a report, print the report and fax it to 630-243-9811. Include the company name, contact information, a brief description of the problem, the report type and criteria with any additional information.
Capture workstation settings (if needed)
Workstation settings can be emailed to OBA by executing the following steps:
1. From the IRMS toolbar point to Help and click About IRMS. The About IRMS screen is displayed.
2. An email screen is opened with the current IRMS values. Enter a brief description of the error in the subject line and enter contact information in the body of the email. Click Send Email to Online.
Schedule a Webex session (if needed)
If a problem is persistent and cannot be resolved based on the requested information, the Support Team may request a Webex session to walk through the problem. If requested, the Support Team will provide the necessary information for the Webex session.
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IRMS Education
Online Business Applications, Inc. offers a variety of education for all its products. Training is provided in Continuing Education Courses and Workshops.
Continuing Education Classes offered at the IRMS Education Center in Lemont, Illinois.
Continuing Education Courses offered at the Client’s location.
Semi-Annual IRMS Workshops offered at the Drug Information Association show and various
locations throughout the country.
How to Find Education Information
Available Courses: www.IRMSOnline.com Services / Education Workshop Information: www.IRMSOnline.com Home Page
Class Location: IRMS Education Center in Lemont, Illinois or Client’s Location Contacting the Education Team
Phone: (630) 243-9810 extension 218
Email: [email protected]
Overview of Training
During the implementation of IRMS, Administration and Basic User courses are taught. At this time, the training courses are tailored to meet the client’s business requirements defined during the Business Development Meeting.
After IRMS has been used for a while, clients can receive additional training by attending workshops, attending continuing education courses at OBA, or scheduling training at the client’s location. Courses are tailored to meet the requirements of the individual and client.
Who Should Receive Training?
New Users - After the initial training of IRMS personnel during implementation, new employees may move into the Medical Information Department to work with IRMS. New Users should receive Basic User Training. If the employee will have Administration responsibilities, they should receive Administration Training.
Users Needing In Depth Knowledge – After using IRMS for a while, some clients request
additional training for specific functions in IRMS. Continuing Education Courses meet this request.
Continuing Education Courses
For more information on our courses, visit our website at www.IRMSOnline.com.
Basic User Training Advanced User Training Reporting & Query
Documents in Depth System Administration System IT Training
Adverse Events Product Complaints
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IRMS Documentation
There are several documentation guides available which describe how to efficiently operate IRMS. Each guide focuses on a specific function of IRMS. The documentation guides are updated to match new releases of IRMS. The guides are available on the website.
How to find Documentation Guides
Website: www.IRMSOnline.com Support / Documentation
New Installation: Documentation Folder installed during installation Contacting the Documentation Team
Phone: (630) 243-9810 extension 203
Email: [email protected]
Current Documentation Guide IRMS Document Management Guide
A detailed guide explaining how to add and maintain documents, set up letter formats, and use letter templates in IRMS.
Additional Guides Available from Online Business Applications, Inc.
IRMS Administration Guide A detailed guide explaining how to setup IRMS, define system security, add users, define parameters, and setup initial table values. IRMS Adverse Events Guide A detailed guide explaining how to use the Adverse Events module of
IRMS. (Module purchased separately.)
IRMS Fields Codes Guide A guide containing a complete listing of merge and replacement fields in IRMS.
IRMS Maintenance Guide
A detailed guide explaining how to maintain the IRMS environment for efficient operations, IRMS maintenance that may be performed, and an overview of the IRMS upgrade process.
IRMS Product Complaints
Guide
A detailed guide explaining how to use the Product Complaints module of IRMS. (Module purchased separately.)
IRMS Quality Assurance Guide A detailed guide explaining how to use the Quality Assurance modue in IRMS. (Module purchased separately.) IRMS Query and Reporting
Guide
A detailed guide explaining how to process queries in IRMS. Also included is an explanation of the reports available in IRMS and how to setup ad hoc reports using the IRMS Report Wizard.
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IRMS User Group
The IRMS User Group was established in 2006. The purpose of the IRMS
User Group is to provide effective two-way communications between Online Business Applications (OBA) and its customers. The goal of the user group is to provide:
A means by which customers can influence the direction, development and support of the IRMS
software product
An efficient mechanism for OBA to share information about IRMS
A forum for the exchange of practical IRMS implementation and user experiences
Contacting the User Group Liaison at OBA
Phone: US Code (630) 243-9810 extension 215
Email: [email protected]
How to Join the IRMS User Group
The IRMS User Group is a fully independent organization. The User Group Chairperson is elected from participating clients. Focus Groups are offered that meet regularly to discuss issues that directly affect the enhancement process of our software. In addition, issues of a general nature affecting the gathering of medical information and industry issues are discussed.
Any client with IRMS installed is welcome to join the user group. Conference calls are held frequently to discuss User Group business. Participation from our clients is encouraged. The meetings are organized and chaired by one of the User Group Members (client).
User Group meetings are held at our semi-annual workshops.
For more information on the User Group, visit our website. To join the IRMS User Group register
Chapter 2 Documents menu
Overview
Document Management provides the ability to create a document repository. A variety of documents can be created including Standard Letters, Product and Reference Documents, and Opening, Closing, and Email Templates. In addition to the repository, IRMS will setup templates, create letter formats, and create images for Response Letters. IRMS will maintain a Document Log. Standard Letters can be imported from legacy systems. Copyright articles can be managed with the Copyright Clearance Center.
Document Management includes the following functionality:
Create a Document Repository including standard letters, product and reference documents, and
opening, closing and email templates.
Create Response Letters with multiple types of documents.
Create Templates for Cover Letters and Standard Letters
Define Images and Logos to use in Response Letters
Import Standard Letters from legacy systems
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Documents Menu
The Documents menu contains selections used for creating and changing documents in IRMS.
Documents Menu
Maintenance… Starts the Document Maintenance
screen. From there you can control the documents used in IRMS.
See the Building a Document
Repository section.
Combo Documents… Starts the Combo Documents
Maintenance screen. From there you can
create and maintain combination
document records and the documents that comprise them.
Template Control… Starts the Template Decision Table screen. From there you can control
how IRMS uses opening and closing documents.
Letter Formats… Starts the Letter Formats screen. From there you can define multiple letter
formats and how IRMS will operate in order to produce letters in those formats.
Images… Starts the Images screen. From there you can instruct IRMS to insert
letterhead graphics, logos, signatures, and other enhancements to letters.
Document Log… Starts the Document Log screen. From there you can see when and by
whom a change was made to a document.
Mass Update… Starts the Mass Document Change using MS-Word screen. From there
you can run a user-defined macro on a group of IRMS documents. Use with
extreme care! The macro will run on each document meeting the selection criteria AND IS NOT REVERSIBLE! This option will only be
available through the IRMS – Main Menu screen.
Mass Import… Starts the Multiple Document Import screen. From here you can import
multiple documents. This option will only be available through the IRMS –
Main Menu screen.
Sample Data… Starts the Sample Document – Requester Information screen. From here
Chapter 3 Types of Documents
Types of Documents
Overview
IRMS maintains its own repository of documents that it uses to create complete, personalized response letters. To provide the user the flexibility of constructing a variety of response letters, IRMS stores each of the components of a letter separately. Each of these components is referred to as a “document”. When the merge process occurs within IRMS, the appropriate documents will all be combined to form a response letter.
This section will explain the different types of documents and provide an example of each. A list of all the various documents is as follows:
Standard Documents contain the information for answering the inquiry.
E-mail Documents contain information for sending email responses.
Global Documents contain information for answering inquiries and were introduced into IRMS in Version 5.4.4.0.
Reference Documents cites the sources for the standard document.
Product Documents contain the indications for the specific product.
Enclosures include package inserts containing additional information regarding the inquiry.
Opening Template documents contain the usual information the beginning of a letter. It also determines the style for the entire letter.
Closing Template documents make up the ending portion of the response letter, including the closing paragraph, the signature, the signer’s name/title, cc’s, and enclosures.14
Standard Documents
A Standard Document is the body or portion of the response letter that answers the question of the requester. Each standard document can contain one or more paragraphs and can contain tables, charts, or images. These documents should be created in a manner so that one or more standard documents can be combined with the opening and closing templates to produce a finished letter that needs no further edits. One or many standard documents can be used in the response letter. To add a standard document to document repository, see the Adding a Standard Document section located later in this guide.
Standard Document Example
Although the product labeling for Ace-O-Hearts® indicates that a dosage of up to 5000 mg per day of dogapril can be used in patients with congestive heart failure, most clinicians advocate a maximum total daily dose of 1000 mg. Doses above this level rarely add to the therapeutic response, but have shown to increase the potential for adverse effects.
E-mail Documents
An E-mail Document is a text template for a response by email to a Contact or Sales Representative. Each E-mail document can contain multiple email addresses, can be associated with a Product, Category and Topic, can refer to an Abstract, and can specify a Title, Bullet Text, Subject, and Keywords. The text can contain one or more paragraphs and use replacement fields for information such as name and date. To add an E-mail document to document repository, see the Adding an Email Document section located in this guide.
E-mail Document Example
To: <<ContactNA>>
On <<Today>> you asked <<Question>>.
We have prepared the following response <<Response>>
Global Documents
A Global Document is a master document that is maintained by corporate and used by local divisions. A Global Document can also be the body or portion of the response letter that answers the question of the requester. Global Documents can not be changed at all. Users can make copies of the Global Documents; however, and can then edit the local versions. To make a copy of a Global Document, see the Adding a Local Standard Document from a Global Document section. Global Response Documents that have expired will cause a once-a-day e-mail to be sent to the E-mail Corporate address. ┼Version Note: the Global Document concept was entered into IRMS in Version 5.4.4.0.
Note:
A user who does not have the “Maintain Corporate Data” security level will still be able to change the showing type in Document Maintenance to “Global” and scroll through the Global document records. This user would have the ability to click the Search, Text, View,
15 and Export buttons, but will not have the ability to make any changes to the Global
Document. This user will also have the ability to copy this global document, by clicking the (Copy the Current record) toolbar button. A copy of the Global (in their division) will be made as a pending local Standard with the same Doc ID.
Reference Documents
A Reference Document is tied directly to a specific standard document by using the same Document ID as the standard document. They contain the citations for that standard document. These will automatically be added to the bottom of the response letter when the standard document is included. To add a reference document to document repository, see the Adding a Reference Document section located later in this guide.
Reference Document Example References:
Atwood JE, Myers JN, Sullivan MJ, Forbes SM, Pewen WF,Froelicher VF: Diltiazem and exercise performance in patients with chronic atrial fibrillation. Chest 1988 Jan;92(1):20-25.
Kawasaki H, Akino M, Fujii S, Kanda K, Oyama Y: The effects of co-administration of diltiazem with digoxin in controlling the ventricular response in patients with chronic atrial fibrillation. Jpn Circ J 1984 Aug;48(8):892. (Abstract 504)
Product Documents
A Product Document is a special document that is used mainly for indications of a specific product. The Product Document will have a Document ID that is identical to the Product Code. Product documents are used mainly for indications. IRMS can be set to automatically include product documents when the appropriate product is chosen. IRMS can be instructed to not include product documents in the response letter, or it can be instructed on where specifically to insert the product document within the response letter. To add a product document to document repository, see the Adding a Product Document section located later in this guide.
Product Document Example
Aspirin (acetylsalicylic acid) is an anti-inflammatory pain killer (NSAID), which is extensively used worldwide for pain relief to reduce inflammation and temperatures and to reduce the risk of heart attacks and strokes.
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Enclosures
An Enclosure can include package inserts and/or articles. Enclosures are not merged into the response letter, but can be appended to the end of the response letter. A maximum of 50 Enclosures can be added to a letter. The title of the enclosure will always be added to the Enclosure List in the response letter.
Enclosures can be assigned to Standard Documents so that when a standard document is selected, the enclosures will be included as well. IRMS can be set to automatically include enclosures when the appropriate product is chosen. Enclosures can be MS Word documents or Adobe (*.pdf) files. IRMS can be instructed to print the enclosures with the response letter or to ignore the enclosures when printing. To add an enclosure to document repository, see the Adding an Enclosure section located later in this guide.
Note:
IRMS can do replacement of text with enclosures. This is done by using the Images table. (Within the Images table, the user can define multiple “Replace Text with Text” records for the Print Task of “Enclosure”.) A list of all of the possible replacement fields are found in the Replacement Fields section of this manual.
Enclosure Example
The bottom of the response letter will show the following information: Enclosures: Product Information
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Opening Template
The Opening Template document makes up the beginning portion of the response letter. It includes the usual information located in an opening, including the date, name, address, salutation, and opening paragraph. This information can be entered into the document as MS Word merge fields. The values for the merge fields are replaced during the “merge” process. A list of all of the possible merge fields is found in the Merge Fields section of this guide. In the following example, merge fields are designated with the symbols << >>.
This opening document also contains the information needed for formatting the response letter, including the margins, paper size, paper source, second page header page layout, character font, paper selection, page headers and footers, etc.
The style of the opening template document establishes the default font of the entire merged response letter. Microsoft Word uses “Styles” to control the formatting of a document. The most often used style is called “Normal”. In this example, Normal style is defined as Arial font at 11 points. Therefore, when you type into a document when Normal style is selected, characters will be set to Arial 11.
It is important to note that when IRMS creates a response letter, it starts with the opening template document. The Normal style defined in this opening document will become the Normal style for the entire letter. Consequently this means that if the Normal style in the opening document is different than the Normal style in a standard document, the letter will be formatted to the font and point in the Normal style of the opening document.
This concept applies not only to the Normal style, but to all styles within the response letter. The exception to this is when any part of a standard document is manually formatted. For example, if during editing, a word is highlighted, then changed to bold and italics in a different font, that format will never be changed.
We recommend that all documents use the same definition of Normal style and that all documents actually use Normal style. To see or edit Normal style in Word XP, - select Styles and
Formatting… from the Format menu, right-click on the Normal style in the Pick formatting to apply box and select Modify…. The Modify Style dialog box will appear. You can change any formatting at this time. A complete description of the style will be displayed near the bottom of the dialog box. If you wish to save this formatting for ALL future documents, check the Add to Template box.
To add an opening template to document repository, see the Adding an Opening Template section located later in this guide.
Opening Template Example
«PrintDate» «FullAddress» «FullSalutation»
XYZ Pharmaceuticals representative, «RepName», has asked me to forward this information regarding «SubjPara1».
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Closing Template
The Closing Template document contains the usual information printed at the end of a letter, such as: the closing paragraph, the signer’s name/title, cc’s, enclosures, etc. To add a closing template to document repository, see the Adding a Closing Template section located later in this guide.
Closing Template Example
Thank you for interest in XYZ Pharmaceuticals and our product «AllProds1». If you should have any further questions, please call me directly at «SignPhone», or call our 24 hot line at 1-800-555-1212.
Sincerely,
<Signature> (This is not a word merge field. Must be hidden text or you will see no signature image.) «SignName» Professional Services «SignTitle» «SignInit»/«UserInit»/«CaseNo» CC:«CC» Enclosure:«Enclosures»
Chapter 4 Response Letter management
Understanding How IRMS Constructs a Response Letter
When you instruct IRMS to merge a response letter, IRMS will first look to the Format field on the Response Letters screen. The format of the letter provides the structure that IRMS will follow to construct the letter. This informs IRMS where to put the templates, if applicable, where to put the Standard(s), where to put their References, whether or not to include the Product Documents and if so where, and whether or not to include the Enclosure(s). If the letter Format dictates that templates are to be included in this response letter, IRMS will now look to the Opening and Closing fields on the Response Letters screen to determine which opening template and closing template to use. IRMS will take the name from the Contact field and will merge additional data into any necessary
mergefields present in the templates and/or documents. IRMS will look to the Signature field on the Response Letters screen, and insert it into the Signature Code. The Language field contains the language that will be used in this letter.
IRMS will look in the Documents Used in this Letter: section of the Response Letters screen to determine the Standard(s) to be included. The format will dictate where to position the standards and their references. The format will also dictate where to position the Product Document, if it is to be included. Again, any data to be merged into mergefields will take place.
Next, IRMS will look to the format to determine if the enclosures are to be included or ignored. If they are to be included, IRMS will find them in the Enclosures Used in this Letter: section of the Response Letters screen.
IRMS combines all of this information and forms a response letter that can be edited, viewed, printed, e-mailed, and/or faxed.
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Letter Formats
Overview
The format of the letter provides the outline, or skeleton, that IRMS will follow to form the letter. It tells IRMS where to put the opening template, the closing template, the standard(s), the product document, the reference(s), and the enclosures. IRMS will look elsewhere to determine which templates, if applicable, and which standards to use.
The four main components of a letter format are the style of the letter – determines the skeleton of the response letter providing the order of the opening template, closing template, and standards (i.e. Standard Letter, Cover Letter, Standalone, Cover Only); the Enclosure Processing (i.e. print the enclosures or ignore the enclosures); the Product Document Location (i.e. none, after opening, before standards, after standards); and the Reference Processing (i.e. at the end of each standard or at the end of all standards).
Although the format is chosen from the Response Letters screen, the formats are given a name and defined through the Letter Formats screen.
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Adding a Letter Format:
1. Select the Division.
2. Enter the name of the format (ex. Cover Letter or Rep Cover Letter), in the Letter Format field. 3. Designate the basic Style of this document. As you change this selection, IRMS will change the
sample on the left to reflect the style entered.
The Standard Letter style inserts the Standard Document(s) between the Opening and
Closing templates
The Cover letter style inserts the Standard Document(s) after the Opening and the Closing.
The Standalone style only contains the Standard Document. It does not contain an Opening,
Closing, Product document, or References.
The Cover Only style contains the Opening Document and the Closing Document. The other
documents are pre-printed and attached to the end of this cover letter
4. From the (After Opening) drop down menu on the sample, select what spacing IRMS will insert after the Opening Template of a letter.
5. From the (Between Docs) drop down menu on the sample, select what spacing IRMS will insert between documents used in a letter.
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6. Determine if you want the enclosures used or ignored, by clicking on the appropriate radio button in the Enclosure Processing section.
7. If the enclosures are used, clicking the Always Include the Pkg Insert… box will cause IRMS to automatically add the package insert for each product as an enclosure. (Package Insert document must be defined in product maintenance.)
Clicking the Suppress Standard Document titles… box will cause IRMS to NOT put the standards into the enclosures list.
Note:
Normally, in a Cover format, IRMS will automatically include the standard documents in the list of enclosures.
8. Choose a Product Document Location from the pick list.
A product document is used to state the approved uses of a drug. Product Documents are defined in Document Maintenance by using the You are Working With: box set to “Product” and the Doc ID set to the product code.
“Do Not Use” – Reserved for OBA use.
“Place After Opening” – The product document is placed after the opening in the cover letter and standard document formats.
“Place Before Standards (Page)”– The product document is placed before the standard document on a separate page.
“Place Before Standards (Para)”– The product document is placed before the Standard letter paragraph.
“Place Before Each Standard (Page)”– The product document is placed before each standard document.
The Cover Letter format is: Opening, Closing, Enclosure List, Page Break, Product Document (PD) 1, Standard Document (SD) 1, Reference Document (RD) 1, Page Break, PD2, SD2, RD2…
23 The Standard Letter format is Opening, Page Break, Product Document (PD) 1, Standard
Document (SD) 1, Reference Documents (RD) 1, Page Break, PD2, SD3… Closing, Enclosure List.
“Place After Standards”– The product document is placed after all the standard documents are printed.
9. Designate which version of the document(s) to use in the E-mail Enabling Options section. The choices are Web (use the Web version) and Standard (use the normal version).
WARNING:
PLEASE TALK TO ONLINE BUSINESS APPLICATIONS BEFORE CHANGING THIS!
Web documents are designated using the Web Doc field in Document Maintenance. If this field is set to “Web”, letters using this format will only show WebDoc documents in the Document Title and Doc ID drop downs.
10. IRMS can save the letter in Microsoft Word format (MS-Word) or in simple text format (Text) for inclusion as the message portion of an e-mail.
11. In the Document Title Processing section, clicking the radio button None will eliminate any title processing.
Clicking the radio button, Use Merge Field, will cause IRMS to activate the CoverTitle merge field.
Clicking the radio button, Insert with MS-Word, will cause IRMS to insert the title of the document using Microsoft Word – with this last option you will be given the opportunity to specify the character formatting to be used for the title (including Bold, Underlined, or Italics).
12. In the Reference Processing section, click the After EACH Standard box, if you would like each reference to appear after its corresponding standard document.
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Click the At the END of ALL Standards box, if you would like all the references as a group to appear at the end of the letter.
You may indicate if you would like IRMS to add Nothing, a new Page, a new Paragraph, or Space before the first Reference.
25 13. In the Closing Processing section, click the Normal radio button if you would like IRMS to
insert the closing as seen in the sample graphic.
Click the Use IrmsClosing Bookmark radio button, if you would like IRMS to look for a bookmark named IrmsClosing and insert the closing at that location.
Note:
The Closing Processing section is only available for Standard styles. 14. Close the Letter Formats screen.
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Example Formats for IRMS
When company first begins to use IRMS, it will be equipped with four default formats. You may alter these formats, rename these formats, and/or add as many additional formats as you wish. The default formats basically mimic the names of the available styles. The default formats are as follows: Standard Letter, Cover, Cover Only, and Standalone. A brief explanation of these formats will follow.
Standard Letter
The standard letter format will put the standards in the middle of the opening and closing, therefore making up the body of the letter.
The style is Standard Letter.
Use the enclosures.
Product Document(s) will appear after the standards. References will appear after all of the standards.
27 The Standard Letter Format Example
Opening ►
Standard ►
Closing ►
References ►
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Cover Letter
The cover letter format will put the standards after the opening and closing. Each standard can start on a new page or be separated with just a paragraph.
The style is Cover.
Use the enclosures.
Product Document(s) will appear after the opening.
References will appear after all of the standards.
The Cover Letter Format Example
◄ Opening Standard ► References ► ◄ Closing
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Cover Only
The cover only format will only consist of the opening and closing. You will manually attach any necessary pre-printed standards.
The style is Cover Only.
Use the enclosures.
Product Document(s) will appear after the opening.
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The Cover Only Format Example
◄ Opening ◄ Closing
◄ Enclosures are attached to the end ►
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Standalone
The standalone format will have all necessary information merged into a standalone document.
The style is Standalone.
Use the enclosures.
Product Documents do not apply.
References do not apply.
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User Defined Formats
IRMS can handle other types of letter formats. An example might be a "Memo" format, which has been created to look like a fax transmittal form. This can be set up by creating another opening "Template" on the Document Maintenance screen. The construction of the response letter would be the same as the "Cover Letter" or "Standard Letter" formats, but the user-defined opening template makes it look like a fax transmittal form.
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Template Control
Overview
For an Opening or Closing template to be selected for use, it must go through a 3 step process. Step one is to add the template to Document Maintenance (this will be explained in the Adding Templates section later in this Guide.) Step two is to add the template to the Template Decision Table (this will be explained in this section.) Step three is to have the template selected in the Response Letters screen.
IRMS uses the Template Decision Table to be able to select an appropriate opening and/or closing for a letter. As you enter the Response Letters screen and choose to start a new letter, IRMS automatically inserts an opening and closing template. (Please note that the only formats that require an opening or closing are when the style of the format is cover, cover only, or standard letter.) Using the Template Decision Table, you must set up the process that IRMS will follow while choosing the appropriate templates. To access this screen, you must select the Template Control… item on the Documents drop down menu.
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Understanding the Process IRMS uses to Select a Template:
When you open the Response Letters screen to begin a new letter, IRMS compares the information from Case Entry with the Template Decision Table and it selects the first template that matches the criteria.
The first criteria that IRMS tries to match is the Letter Format field with the letter format chosen on the Response Letters screen. IRMS then compares the values in the Case Type, Source, Requested By, Handling, and Contact Type fields with the corresponding values in the case.
IRMS chooses the first opening/closing where the values in the case match all the equivalent fields in the template that are not blank. So, as IRMS is going through the records, it will stop as soon as it finds one where the fields in the case match everything that has been specified in a template control record.
As a result, when sequencing numbers, give the most detailed template control records the smallest numbers. Give the least detailed template control records the largest numbers.
Adding a Template Control Record:
1. Select the new record button ( )on the record navigation bar at the bottom of the screen. 2. Leave the Division field blank, if you would like this template to be available to all divisions. If
you would like it to only be available to a specific division, then select it here. 3. The Department field should be pre-filled with department.
4. Choose the Language of this template.
5. Select if this template is an opening or closing from the Open/Close field.
6. Choose the document id of this template from the Document ID field. (This is a mandatory field.)
7. Choose a format from the Letter Format field. (This is not a mandatory field.)
8. Select the Case Type from the drop down menu (i.e. Medical Information or Adverse Events). (This is not a mandatory field.)
9. Choose a Source, Requested By, Handling, and/or Contact Type from the corresponding combo boxes. (None of these fields are mandatory – you may populate none, one, two, three, or four of these fields.)
10. You must now enter a number in the Seq field. This field tells IRMS in what order to check through the templates to find a match for the new response letter.
Enter a number that is smaller than all other numbers, if you would like IRMS to check this control record first.
Enter a number that is larger than all other numbers, if you would like IRMS to check this
control record last.
Enter a number that is somewhere in the middle of two other numbers, if you would like
IRMS to check this control record between two other specific control records. 11. Close the screen.
35 Example of Adding a Template Control Record
There is an opening template in Document Maintenance called “Rep Letter Fax Opening”. Now I would like IRMS to be able to choose the template, so I need to add it to template control. I must select a language, opening/closing, and a document ID. Now I must decide how specific I would like to be for IRMS to be able to choose this opening. I only want to use this letter when a representative has sent an inquiry for a health professional and the rep would like me to fax a letter to the health professional. This is a very specific type of letter, so I will put a small sequential number so that IRMS has to filter through this template control record very early.
1. Choose English as the Language.
2. Choose Opening from the Open/Close field.
3. Select my Document ID, which is Rep Letter Fax Opening. 4. Choose Standard Letter for Letter Format.
5. Choose Representative for Requested By. 6. Choose Fax for Handling.
7. Choose Health Professional for Contact Type.
8. Choose 4 for the Seq, as it fits between a more specific template control record number 1 and a less specific template control record number 5.
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Images Control
Overview
The Images screen is used to define graphical elements that appear on response letters. These images include scanned signatures, company letterhead, and logos. This screen can also be used to define a Word header to be placed on the first page of responses (such as samples or draft copies). Please see the three examples at the end of this section.
Adding Images to a Response Letter
1. Access the Images screen by selecting the Images… item on the Documents drop down menu. 2. Choose the Division if it is applicable.
3. Choose the Print Task(s). You may select one, or to select more than one, separate each task with a comma. (Earlier versions of IRMS required that each task be separated with a comma only. However, starting with IRMS version 5.4.7 the system will accept a comma and a space between each of the tasks.) The task options are as follows: E-mail, Enclosure, Fax, Final, and Sample.
4. Choose the Action. The options are as follows: Insert a Document, Insert a Text Watermark, Insert a Text Watermark Box, Insert an Envelope, Insert an Image, Insert Text into Header, Overlay Text with an Image, Replace Text with an Image, Replace Text with Text, and Replace Text with Signature.
5. The fields that are enabled depend on which Action is being taken. Not all fields apply to all actions. Fill in the remaining fields that are enabled.
37 Field Definitions of the Images Screen
Field Explanation and Comments
Print Task(s) Instructs IRMS when to apply this element. You can use more than one at a time, separated by commas.
mail – when a letter is processed with an Output Mode of E-mail.
Enclosure – when an enclosure (that is a Microsoft Word document) is printed.
Fax – when a letter is processed with an Output Mode of Fax. Final – when a letter is processed with an Output Mode of Final. Sample – when a letter is processed with an Output Mode of Draft. Action The specific action that IRMS is to take.
Letter Format The letter format to which this graphic element should be applied. Leave this field blank if you want this element applied to ALL letter formats.
Suppress on Customs
“Yes” will NOT use this image on letters that have been
marked as customized. This allows you to force a manual
signature on these letters. “No” will use this image on all
letters.
Order The sequence in which IRMS will apply this graphic. This may be important if images overlap.
Text to Find A piece of text to look for. Uses the same rules as a Microsoft Word find.
Image File Name The image file to be used. The file name must be in the IRMS System Folder. To place it in a folder within this folder, specify the folder name as part of the image file name. For example, to place the image in a folder named IMAGES, specify
IMAGES\filename.ext.
- or –
Watermark Text The text to be inserted in the text box being added to the header.
- or –
Text The replacement text on a Replace Text with Text action. Horizontal Position The horizontal (left/right) position of the image.
Vertical Position The vertical position of the image. Image Width The width of the image.
Image Height The height of the image. Font Name The font to be used for the text.
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Font Size The point size of the font.
Bold Makes the font bold.
Italics Makes the font italicized.
All Caps Use the ALL CAPS option (see Word). Underlining Makes the font underlined.
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Examples of the Image Screen in Use
Disclaimer Example
The following is an example of applying a disclaimer to the draft copy of a letter.
Field Value and Explanation
Print Task(s) Sample – Apply the image only if the Output Method is Draft.
Action Insert a Text Watermark.
Letter Format Leave it blank to insert the image regardless of the Letter Format.
Suppress On Customs
No – include the disclaimer even on customized letters.
Order 1
Watermark Text Draft Copy Only - The text of the disclaimer.
Horizontal Position 1.65" – Place the text box 1.65 inches from the left edge of the page. Vertical Position .50" – Place the text box 0.50 inches from the top of the page. Image Width 5.60" – Specifies that the text box is 5.60 inches wide. Image Height 0.60"- Specifies that the image is 0.60 inches high. Font Name Arial – Use the Arial font for the text.
Font Size 10 – Use 10 point font for the text. For this example, the Image screen will look as follows:
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Letterhead Example:
This example applies an image to simulate/duplicate company letterhead.
Field Value and Explanation
Print Task(s) E-mail,Fax – Apply the image for both of these Output Methods.
Action Insert an Image.
Letter Format Leave it blank to insert the image regardless of the Letter Format.
Suppress
On Customs
No – include the letterhead even on customized letters.
Order 1
Image File Name AcmeLtrh.pcx - The file name of the image to be used. Place the AcmeLtrh.pcx file in a folder named IMAGES in the IRMS System Folder (usually named IRMS5).
Horizontal Position 2.90” – Place the image 2.9 inches from the left edge of the page. Vertical Position 0.42” – Place the image 0.42 inches from the top of the page. Image Width 2.78” – Specifies that the image is 2.78 inches wide. This should
reflect the actual size of the image to prevent distortion. If you need to resize the image, make sure that the width and height are kept in proportion.
Image Height 1.04”- Specifies that the image is 1.04 inches high. This should reflect the actual size of the image to prevent distortion. If you need to resize the image, make sure that the width and height are kept in proportion.
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Signature Example:
The following is an example of applying scanned signatures based on the person designated as the signer of the letter. For a detailed description on setting up and troubleshooting signatures, see the IRMS Knowledge Base.
Field Value and Explanation
Print Task(s) E-mail,Fax,Final – Apply the image for all of these Output Methods. This will not apply a signature if the Output Method is Draft.
Action Replace Text with an Image – IRMS will look for the text specified in the Text to Find field and replace it with the image designated in the Image File Name field.
Letter Format Leave it blank to insert the image regardless of the Letter Format
Suppress
On Customs
Yes – forces the signer to manually sign any customized
letter that is going out in their name.
Order 1
Text to Find <Signature>^p^p – IRMS will look for the text <SIGNATURE> followed by two carriage returns.
Image Width 3” – Specifies that the image is 3 inches wide. This should reflect the actual size of the image to prevent distortion. If you need to resize the image, make sure that the width and height are kept in
proportion.
Image Height 0.75”- Specifies that the image is 0.75 inches high. This should reflect the actual size of the image to prevent distortion. If you need to resize the image, make sure that the width and height are kept in proportion.
Chapter 5 Building a Document Repository
The Document Repository is comprised of the following types of documents – Opening and Closing Templates, E-mail Templates, Standard, Global, Reference, Product, and Enclosure documents. The document Repository is maintained in Document Maintenance.Product documents, Reference documents and Enclosures are associated with a Standard document in Document Maintenance.
There is also a feature that allows individual documents to be combined into one “Combo” document. Once a Combo document is created, it can be associated with a standard document. When a standard document is selected in a Response Letter with an associated Combo document, all the documents defined in the Combo document are included in the Response Letter.
Document content is maintained in MS Word. Content can be entered into Word when creating a document or imported from another Word document.
Document Maintenance Window
The Document Maintenance window is made up of four sections. The first section at the top of the window displays the Selection, Status, and Division. The second section on the left side of the window contains meta-data specific to the document type. The third section on the middle and right side of the window contains additional meta-data that is common to all document types. The fourth section on the bottom of the window (displayed only for Standard documents) contains a place to associate Enclosures, Product documents, and Combo documents with the Standard document. Field definitions and toolbar button explanations are located in the Field Definitions and Toolbar chapter on page 137 in this guide.
To access Document Maintenance, select one of the following options below:
Click Documents from the IRMS Main Menu, or
From the IRMS Main Menu bar, click Maintenance from the Documents menu, or
Click Documents from the IRMS Main Menu toolbar.
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Document Maintenance Screen and Toolbar
Common Fields for All Document Types
The fields displayed in the middle and right sides of the screen are common to all document types. Below is an explanation of the fields.
Common Fields in the Second Column
Field
Value and Explanation
Status Select from the pick list the Status applied to the document. The four types of status are:
“Approved” – the document is available to use
“Pending” – the document is currently being written and/or changed and is not available to use.
“Inactive” – the document is inactive and cannot be used “Archived” – the document has been replaced with an updated version and is not available for use.
Control # A unique number automatically assigned to every document by IRMS.
Sub Type An additional classification for the Document Type. Select the Sub Type from the pick list. The Sub Type is defined in the “Document Sub Type” Table Name in General Tables.
45 File Name If the document is created in IRMS, then the folder and file name
location is automatically populated by IRMS. If the document is created outside of IRMS, a file path and file name should be entered by the user.
Division The name of the Division that owns the document. The Division is defined in the Division Parameters.
Department The name of the Department that owns the document. The Department is defined in the “Department” Table Name in the General Tables.
Language The language the document is written. If responses are given in multiple languages, each document has its own version. The Language is defined in the “Language” Table Name in the General Tables.
Author The author of the document. The Author is defined in the “Document Author” Table Name in the General Tables. Text The content of the document used in the Response Letter. The
content is entered or imported from a Word document. See the specific types of documents for further information on entering text. Location The bin location of the preprinted document.
Misc 1 Data in this field is determined by the client. The label can be changed in the Division Parameters in the Document/FAQs/Rep tab.
Misc 2 Data in this field is determined by the client. The label can be changed in the Division Parameters in the Document/FAQs/Rep tab.
Misc 3 Data in this field is determined by the client. The label can be changed in the Division Parameters in the Document/FAQs/Rep tab.
Common Fields in the Third Column
Edit Date The last date the document was edited. The date is automatically assigned by IRMS.
Approved Date The date the document was approved. The date is automatically populated when the Status is changed to “Approved”.
Archived Date The date the document was archived. The date is automatically populated when the Status is changed to “Archived”. An archived document is not available to use.
Search Date The date that research was last completed for this document. Expiration Date The date this document will expire and should be reviewed.
Additional parameters are set up in the Division Parameters. For more information on using expiration dates, see “Establishing Notification of Expired Documents” later in this chapter.
