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
OverviewThe 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.
Letter Formats Screen Shot
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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…
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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.
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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.
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The Standard Letter Format Example
Opening ►
Standard ►
Closing ►
References ►
Enclosures ► Enclosures are attached to the end.
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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
Enclosures► Enclosures are attached to the end
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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.
References do not apply.
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The Cover Only Format Example
◄ Opening
◄ Closing
◄ Enclosures are attached to the end ► Standards are manually added 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.
The Standalone Format Example
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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.
The User Defined Format Example – “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.
Template Decision Table Screen Shot
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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.
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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.
Screen Shot of the Images Screen
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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 Width 5.60" – Specifies that the text box is 5.60 inches wide.