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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.

The Document Maintenance window is displayed.

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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.

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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.

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Changed Date The last date a change was made to the document. The date is automatically populated by IRMS.

Web Doc? Selecting the checkbox indicates that a web version of the document exists. The field to the right is the date the web version of the document was approved.

Time Spent Use varies by IRMS licensees.

Access Control Section

The Access Control section defines the level of security for Service Representatives and Contact Types. There are four different levels for Service Reps and two different levels for Contacts.

Service Rep Grants rights for the Service Rep to use the document based on the level selected. Select Level 1, 2 3 or 4 to grant rights to the document. To grant access to all the preceding levels, click the arrow to the left of the checkbox. For example, to grant access to Level 1, 2, and 3, click the arrow to the left of the third checkbox.

Otherwise, select the specific checkboxes to grant access to that level. If all checkboxes are selected, the document can be used by all Service Reps. At least one checkbox should be selected. The Service Rep Access Level rights are granted in Group Security.

Contact Grants rights for the Contact to view the document based on the Contact Type for that Contact. Select Level 1 or 2 to grant rights to the document. If both checkboxes are selected, the document can be used by all Service Reps. At least one checkbox should be selected.

The Level for the Contact Type is defined in the “Contact Type”

Table Name in the General Tables.

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Building Templates

Templates are used to create written responses to a case in multiple formats. Responses to an internal case may be handled differently than a case from a health professional or company representative. If a response is in multiple languages, then different Standard Documents need to be created for each language.

For this reason, IRMS provides a feature to customize the basic format of these responses. This is referred to as Templates. These templates are word processing documents created and accessed in the Document Maintenance window with a Type of "Template".

Templates include opening and closing templates that are built to provide different responses. Once built, how the templates are used (opening and closing) is defined in the Template Decision Table.

Adding an Opening Template

To add an Opening Template, :access the Document Maintenance window.

1. Select “Template” from the You are Working with: field. The window for a Template document is displayed.

2. Click the New button on the Navigation bar.

3. Enter a unique Doc ID for the template. If applicable, enter a Product, Category, and Topic.

Enter Abstract, Title, Bullet Text, Subject, and any applicable Key Words.

4. Enter information into the remaining common fields.

5. There are two different ways to enter content into a document. Content can be created in the document or imported from a word document.

To import content from an existing Word document, click the Import button. The IRMS Document Import- File Selection window is displayed. Navigate to and select the opening template word document. Click the Import button. The opening template is imported into the document and displayed in the Text box. To view the document in read-only mode, click the Text or the View button.

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- or -

To create the content, click the Edit button to start with a blank Word document. (See the Tips on Creating an Opening Template section.)

6. IRMS uses openings and closings with a Status of Approved and a Language that matches the language specified in the case. Once the document is complete, change the Status from

“Pending” to “Approved”. The document must have a Status of “Approved” to be selected in the Template Decision Table and Response Letters.

7. Define the template as an “Opening” or “Closing” Template in the Template Decision Table.

Note: The template is not available for use on the Response Letters screen until it has been added to the Template Decision Table. (See the To Add a Template Control Record section.)

Tips on Creating an Opening Template

The "Opening" template must contain the following information:

Page Setup (Margins, Paper Size, Paper Source, and Layout)

Format (Character Font, Spacing, Alignment)

Headers & Footers

Response Letter Opening Merge Fields Creating an Opening Template:

1. Create a word processing document as you would any other.

2. Set normal style to the correct font and point size. You can do this by selecting Style… under the Format menu. Click , then click and choose Font…. Select the correct font and size and then click .

3. Using the word processing insert field (merge), place the merge field, <<PrintDate>>, where you want the letter date to print on the first page.

Notes:

Remember that the letterhead will occupy the top portion of the paper.

How to insert a merge field and a complete listing of all of the possible Medical Information merge fields is located in the Merge Fields section of this guide.

4. Place the merge fields for <<FullAddress>> where you want this information to print.

(FullAddress consists of the person’s name, address, city, state/province, postal code and country.)

5. Place the merge fields for <<FullSalutation>> where you want this information to print.

(FullSalutation consists of “Dear Mr. Smith:”)

6. Type an introductory paragraph and place the appropriate merge fields where you want this information to print.

7. Set the paper source. If you are using a printer with multiple trays, and letterhead and the paper is in one of those trays, you must specify which tray the first sheet will come from, and which tray all other sheets will come from.

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You can do this by selecting Page Setup… from the File menu. Click the tab (this tab is labeled “Paper” in Windows XP). Choose the tray for the First page: and then choose a tray for the Other pages:.

8. Select a header.

You can do this by selecting Header and Footer from the View drop down menu. Type the information you want to appear as the header inside the box provided.

If you want a header to appear on all the pages of the response except for the first page, you must specify this in the Layout tab of Page Setup.

You can do this by selecting Page Setup… from the File drop down menu. Click the tab. In the Headers and Footers section, click the Different first page box. Then enter the Header and Footer from the View drop down menu, and type the information you want to appear as the header on the first page.

Then move the cursor to the second page’s header, and type the header that you want to appear on page 2 and beyond. You will have to insert a page break temporarily to get to the second page header. Remove the page break when you are done.

9. Save document in Word.

Sample Opening Template Document

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Adding a Closing Template

Closing templates are word processing documents you create and store in the Document Maintenance screen with Type = "Template". They are created similar to opening templates.

To add a Closing Template:

1. Enter the Document Maintenance screen.

2. Select “Template” from the You are Working with: field.

3. Click the (Create a new document control record) toolbar button.

4. Click the button if the document already exists. The IRMS Document Import- File Selection screen will be displayed. Select a closing template word document. Click the

button. The closing template word document will be shown in the Text box. To view the document in read-only mode, click the button or the button.

- or -

5. Use the button to start out with a blank Word document. (See the Tips on Creating an Closing Template section.)

6. Enter a DocID and a Title that briefly describe this new closing template.

7. IRMS uses openings and closings with a Status of Approved and a Language that matches the language specified in the case. So select Approved in the Status field.

8. The template will not be available for use on the Response Letters screen until it has been added to the Template Decision Table. (See the To Add a Template Control Record section.)

51 Tips on Creating a Closing Template

To create a closing template:

1. Create a word processing document as you would any other.

2. Type a closing paragraph and “Sincerely,”.

3. Using the word processing insert field (merge), place the merge fields, <<SignName>>,

<<SignTitle>>, <<SignPhone>>, where you want the letter to print this information.

Note:

How to insert a merge field and a complete listing of all of the possible Medical Information merge fields is located in the Field Codes Guide.

4. Place the merge fields, <<SignInit>>, <<UserInit>>, and <<CaseNo>> where you want the letter to print this information.

5. Type “CC:” and “Enc.” and include the merge fields <<CC>> and <<Enclosures>> where you want the letter to print this information.

Note:

“If” statements are used to control merge fields like CC’s and Enclosures. This is needed to prevent the labels for these merge fields from printing when there are no ccs or enclosures to print.

6. Save the document in Word.

Sample Closing Template Document

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Creating Standard Documents

When you are adding standard documents, you will probably want to assign enclosures to those standard documents. This might include scanned versions of package inserts for each product as well as reprints and diagrams that you might include in a response letter. You will then be able to assign enclosures to each standard as you create it. In addition, at the same time you are creating the standard documents, IRMS will enable you to define and build a separate document with the

references for that standard. In this way, IRMS will be able to combine the standards, references, and enclosures together using a variety of Letter Formats.

1. Navigate to the Document Maintenance screen.

2. The window is displayed with the You are Working with field set to “Standard”. If it is not, select “Standard” from the pick list. The window for a Standard document is displayed as shown.

3. Click the (Create a new document control record) toolbar button.

4. A prompt is displayed asking if you want to make a standard document from a Global Document.

If you select Yes, you will be switched into a special Document Search screen – continue to the next step. If you select No, continue to the next step – step 5.

This search can only find Global documents.

When the appropriate Global document is found click the Select button from the toolbar to copy the Global information to a local Standard with a blank Doc ID and a blank Title.

Proceed to step 5.

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5. Enter a DocID for the Document. The DocID should be short but meaningful. (Users will be able to select documents by either DocID or Title.)

6. Select a Product that the document will be associated with. If the Document is to be made available for multiple products, do not select a Product.

Note: If the UserAccessByProduct parameter is set to “Yes” in the System Parameters, the Product pick list will only display only the Products the Service Representative is authorized to use.

7. Select a Category that the document will be associated with.

8. Select a Topic that the document will be associated with.

9. Select an Abstract that the document will be associated with.

10. Enter a Title for the document. The title appears in reports where the document title is displayed.

The title also appears in the drop downs when selecting documents. It can also be used when searching for documents.

11. Enter the Bullet Text for the document. The Bullet Text is used when a response letter is generated using the cover format. The bullet text will be auto-generated by IRMS by using the Product Trade Name – the Title. To change the auto-generated bullet text, simply type over it.

12. Enter the Subject of the document as it would appear in the opening paragraph of a response letter. Do not start the subject with a capital letter and do not end with a period.

13. Enter Key Words. Key Words are used for searching documents on the Document Search screen. To enter more than one keyword, separate the keywords with a comma.

14. Enter information in the remaining fields that are necessary.

15. Enter the content of the document in the Text field. Content can be entered and/or edited by doing one of the following:

Import the content from a Word document - click the button to access an existing Microsoft Word document. The Import Document – File Selection window is displayed.

Select the document to import.

Edit the content of a document – click the button to start out with a blank Word document. If this is an existing document, the contents of the document is displayed in a Word document. Edit the document in Word. When the document is complete, save the document. The new or changed document is imported into the Text field.

Link the content of this document to a document outside of IRMS – click the button to link to a document or .pdf outside of IRMS.

Reference Manager

Reference Manager version 12.0.0 interfaces with IRMS. When using Reference Manager, insert the citations in Word. The bibliography is automatically created in the Response Letter. Verify that the Division Parameters for Reference Manager are defined.

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Associating Enclosures, Product Documents and Combo Documents to a Standard Document

16. Enclosure Documents

To associate an enclosure with the standard document, click the ‘*’ (New) button to select a new enclosure, and then select an enclosure from the pick list. The pick list displays enclosures for the product and any enclosures not defined for a specific product.

Enclosure Documents can also be selected by clicking Edit Document Enclosures from the Shortcuts menu.

To create an enclosure document, see Creating an Enclosure Document section later in this chapter.

17. Product Documents

To associate a product document with the standard document, click the ‘*’ (New) button to select

To associate a product document with the standard document, click the ‘*’ (New) button to select

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