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Oracle Argus Safety eMDR Best Practices Document Release 8.0.1 E68590-01 |
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# Oracle Argus Safety

eMDR Best Practices Document

Release 8.0.1

E68590-01

November 2015

This document provides information on using eMDR to switch from MedWatch Device reporting, and special considerations about eMDR generated in this release that customers must be aware of. It contains the following sections:

- Configuration

- Special Considerations

- Related Documents

- Documentation Accessibility

## Configuration

This section contains the following topics:

- Configuring a Reporting Destination for the eMDR Profile

- Configuring Common Profile Switches for eMDR Reports

- Configuring Reporting Rules

- Configuring Codelists

### Configuring a Reporting Destination for the eMDR Profile

Oracle recommends you configure a Reporting Destination with the following settings to enable reports to be sent in the eMDR format:

- Select Message profile as CDRH eMDR V1.0 MESSAGE TEMPLATE (standard profile for eMDR).

- Acknowledge the profile is disabled when you select the eMDR profile.

- When eMDR profile is selected, Message type is automatically set to XML and Maximum # of reports to include in the msg is set to 1 as report batching in xml is not supported.

When Device reporting is being done using MedWatch Devices for Regulatory reporting and eMDR for pilot testing, Oracle recommends you create a new Reporting Destination for eMDR.

When Device reporting is switched over from the MedWatch Devices to eMDR, Oracle recommends you configure eMDR to the Reporting Destination that was used for sending the MedWatch Devices report.

### Configuring Common Profile Switches for eMDR Reports

The following are the recommended Common Profile Switch settings:

- Default Reporting Destination for draft eMDR generation must be set to a Reporting Destination that is configured with the eMDR profile.

- File attachments allowed for eMDR, by default, is set to various attachment types supported; you can modify this setting based on the company's requirements.

- Allowed file size for eMDR is set to 50 MB; you can modify this setting based on the company's requirements. Oracle recommends retaining the default value or entering a lesser number.

- Default view for eMDR is set to the XML view; you can modify this setting based on the company's requirements.

### Configuring Reporting Rules

When Device reporting is being done using MedWatch Devices for Regulatory reporting and eMDR for pilot testing, Oracle recommends you create new Reporting rules for eMDR.

When Device reporting is switched from MedWatch Devices to eMDR, Oracle recommends you configure eMDR to a new Reporting rule and to deactivate the rule for the MedWatch report.

### Configuring Codelists

An Occupation codelist is provided with Factory data along with NCI_Codes. If companies have already entered data in this codelist, and if this data has been used in the Device cases prior to upgrade to 8.x release, Oracle recommends you do the following:

- Update NCI codes for the existing data in the Occupation codelist using the Flexible Data Re-categorization codelist.

- Set Display to No for the new factory data provided in the Occupation codelist using the Standard codelist.

Note: For more information on Mappings, refer to the eMDR Mapping document.

## Special Considerations

1. As per eMDR guidelines, attachments sent with previously submitted reports must not be sent with follow-up reports. Since no check to verify that attachments were submitted previously exists, Oracle recommends you select the Attachment classification that does not qualify for eMDR reporting in the follow-up revision of the case to ensure that reports are not sent again. Alternately, you can customize the mapping logic for the data element includeddocument.

2. Though eMDR generated in Argus Safety is regulatory compliant, mappings for certain optional data elements are not provided. Customers can make the following configurations to provide custom mappings for user-defined fields for such data elements.

   1. Define user-defined field:

      User-defined fields can be used as per the following table and users can input data in these fields from the Case Form UI.

      eMDR Data element | Description of Data element | UDF in UI | UDF Type | Length as per eMDR specification
      --- | --- | --- | --- | ---
      mfremail | Manufacturer Email | Products -> Product Information | Text | 50
      reprocaddress1 | Reprocessor Address Street Line 1 | Products -> Product Device | Text | 30
      reprocaddress2 | Reprocessor Address Street Line 2 | Products -> Product Device | Text | 30
      reproccity | Reprocessor City | Products -> Product Device | Text | 30
      reprocstate | Reprocessor State Code | Products -> Product Device | Text | 2
      reproccountry | Reprocessor Country Code | Products -> Product Device | Text | 3
      reprocpostalcode | Reprocessor Postal Code | Products -> Product Device | Text | 10
      reprocemail | Reprocessor Email | Products -> Product Device | Text | 50
      reprocfax | Reprocessor Fax Number | Products -> Product Device | Text | 26
      ufaddress1 | User Facility Address Street Line 1 | General-> General Information | Text | 30
      ufaddress2 | User Facility Address Street Line 2 | General-> General Information | Text | 30
      ufcity | User Facility City | General-> General Information | Text | 30
      ufstate | User Facility State Code | General-> General Information | Text | 2
      ufcountry | User Facility Country Code | General-> General Information | Text | 3
      ufpostalcode | User Facility Postal Code | General-> General Information | Text | 10
      ufcontactfirstname | User Facility Contact First Name | General-> General Information | Text | 15
      ufcontactmiddlename | User Facility Contact Middle Initial | General-> General Information | Text | 1
      ufcontacttitle | User Facility Contact Title | General-> General Information | Text | 4
      ufcontactemail | User Facility Contact email address | General-> General Information | Text | 50
      fmfremail | Manufacturer Email | General-> General Information | Text | 50
      devicenotevaluatedreasonother | Other Reason for Non Evaluation | Products -> Product Device | Text | 40

   2. Provide custom export logic for the required data element:

      The eMDR standard profile can be used to create a copy of the custom profile, and the SQL statement for the required data element can be modified to map the data element to the corresponding user-defined field.

   3. Configure a Reporting Destination with the custom eMDR profile:

      Specify the custom eMDR profile created in step 2 in the Reporting Destination identified for sending eMDR reports.

   4. Modify the eMDR XSL file:

      Modify eMDR XSL files present in the following locations:

      Web Server:

      {ArgusInstallPath(FromArgus.ini)} \ Argus.NET\CommonWebUIComponent \HL7\XSLT\AS\eMDR

      AGServer:

      {ArgusInstallPath(From Argus.ini)}\ Argus.NET\CommonWebUIComponent\HL7\XSLT\AS\eMDR

## Related Documents

For more information, see the following documents for this release:

- Oracle Argus Safety Installation Guide

- Oracle Argus Interchange User's Guide

## Documentation Accessibility

For information about Oracle's commitment to accessibility, visit the Oracle Accessibility Program website at `http://www.oracle.com/pls/topic/lookup?ctx=acc&id=docacc`.

Access to Oracle Support

Oracle customers have access to electronic support through My Oracle Support. For information, visit `http://www.oracle.com/pls/topic/lookup?ctx=acc&id=info` or visit `http://www.oracle.com/pls/topic/lookup?ctx=acc&id=trs` if you are hearing impaired.

Oracle Argus Safety eMDR Best Practices Document,

E68590-01

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