eMDR Reporting Setup

 

Please select the object link below for more information on how to configure the object.

Object

Shared with other SmartSolve© Applications

Required for SmartComplaintsTM

Numbering Schemes

Yes

Yes

Submission Status

No

Yes

Regulatory Reporting Policy

No

Yes

FDA eSubmission Link

No

Yes

MedWatch PDF Template

No

Yes

MedWatch HTML Template

No

Yes

Country Codes

No

Yes

State Codes

No

Yes

CDRH Codes

No

Yes

Submission Codes

No

Yes

 

 

Introduction

eMDR stands for electronic Medical Device Reporting. The Food and Drug Administration (FDA) allows electronic receipt and processing of medical device adverse event reports. These MedWatch 3500A reports are required of manufacturers, user facilities, and importers when an adverse event occurs.

The eMDR feature in SmartComplaintsTM has been developed to support the FDA's Center for Devices and Radiological Health (CDRH) HL7 requirements to generate a complaint eMDR file.  Currently, the FDA accepts electronic medical device reports via the following two FDA gateway options:

Options

Description

WebTrader

Generate the 3500A eMDR xml file from SmartComplaintsTM and use the FDA's Web Trader application to send the file to the FDA Gateway. This option is for customers who do not have a B2B mechanism and is available for free for use by the FDA.

 

B2B

Generate the 3500A eMDR xml file from SmartComplaintsTM and use your company's B2B (AS2 protocol) transport mechanism to send the file to the FDA Gateway.

 

 

eMDR Reports Accepted by the CDRH

The following reports are accepted by the CDRH eMDR program:

Attachments as part of the electronic file (with PDF or zip file format)

o    5 day reports

o    Initial (30 day) reports 

o    Follow-up reports

 

Reports Not Currently Accepted by the CDRH

The following reports are not accepted by the CDRH: 

 

eMDR Restrictions

The following list describes current functionality restrictions:

·         eMDR Html data entry template is not currently compatible with Forms Configurator. 

·         ISO 3166 three digit country codes must be used.

·         US Postal Service two digit codes must be used. For additional information check the following URL: http://www.usps.com/ncsc/lookups/abbreviations.html#states.

·         Three specific Null Values that have to be used are NA, NI, ASKU

 

eMDR Workflow

SmartComplaintsTM will generate an HL7 compliant eMDR, xml file to send to CDRH via the FDA ESG (Electronic Submission Gateway). The FDA Gateway is used by all centers of the FDA (CDER, CDRH, etc) as they receive many types of electronic submissions. The eMDR will be sent as an xml file to CDRH who will decode and save MedWatch data automatically into MAUDE (Manufacturer And User facility Device Experience database). Any attachments sent will flow into the FDA’s attachment database.

The following diagram shows how information flows from the complaint record into the MedWatch PDF and into the html data entry template and then becomes the eMDR xml file. The specific files that are used to create the records are defined in the data flow.

 

 

 

 

In order to transfer an eMDR to the FDA, the user must build the documents to be transferred and then transfer them.

Build the Information: generate MedWatch data using HL7 ICSR standard, a message format that is mapped to the 3500A.

How can you do this?

·         eSubmitter – downloadable software from FDA website

·         SmartComplaintsTM generates the eMDR HL7 complaint xml file!

 

Transfer the Information: The file will be transmitted electronically to the FDA’s Electronic Gateway (FDA ESG) where it will automatically load the MedWatch file into the FDA’s MAUDE database.

How do I Transmit the electronic file?

 

FDA Electronic Submissions Gateway (ESG)

The FDA Electronic Submissions Gateway (ESG) enables the FDA to process regulatory submissions automatically while it functions as a single point of entry for the receipt and processing of all electronic submissions for all FDA centers. This environment is secure and complies with secure messaging standards. The FDA ESG does not open or review submissions; it automatically routes them to the appropriate FDA Center or Office. A submission to the FDA through the gateway is processed as follows:

1.     FDA ESG receives an inbound submission (this would be the 3500A xml file generated from SmartComplaintsTM).

2.     FDA ESG sends a Message Delivery Notification (MDN) or Acknowledgment 1 notification to the submitter. Acknowledgment 1 confirms that the submission was successfully received by the FDA ESG and provides the official date received by the FDA. This Acknowledgement verifies your digital certificate and the FDA ESG recognizes you.

3.     The submission is automatically transferred to the CDRH Center.

4.     Acknowledgment 2 is sent by CDRH to indicate that the submission reached the CDRH center and has now been routed to the MAUDE\CDRH database (MAUDE) for final verification.

5.     The CDRH Center validates and processes the submission. 

6.     Acknowledgment 3 is sent by CDRH to indicate that the submission successfully loaded into the Adverse Event database. It also notes any errors that occurred during validation and loading.

NOTE: Electronic MDR reporters must register as trading partners with the ESG to submit to the Gateway. For further information, visit http://www.fda.gov/esg/. The site contains an extensive manual to assist in understanding ESG requirements as well as a contact email address for ESG questions. 

 

 

Transfer Mechanisms

Users need to determine how they will transfer their eMDR file to the FDA. The accessibility of a company with existing B2B mechanisms usually determines the options for eSubmission transmission. No matter which solution the user chooses for transmission, all users need a digital certificate. This digital certificate is a two part electronic key that, when matched together, defines your company to the FDA.

The following information describes high or low volume submissions to the FDA:

Transmission Type

Recommendation

WebTrader

Web Trader is a browser based mini-B2B conduit offered for free by the FDA. It is used by manufacturers to send their eSubmitter or HL7 compatible files to CDRH. To use this software you need an internet browser and a digital certificate.

Please see Scenario 1.

 

B2B

If you have a high volume of submissions, then a B2B solution is preferable. The process for the submission is similar to Web Trader except that at defined intervals the B2B collects all xml forms that have not been previously submitted and automatically submits them to the FDA. Once they have been received, the FDA sends the three acknowledgements which then have to be manually entered into the SmartComplaintTM record. The B2B solution must be able to comply with an AS2 protocol, and there are two “attributes” that need to be defined in the MIME header of the file for communication with the FDA ESG. These are defined in the detailed document at the FDA ESG website.

Please see Scenario 2, 3, or 4.

 

 

NOTE: Even if you are going to transfer your eMDR file using a B2B mechanism your initial testing account should also include the Web Trader. For customers who are not familiar with electronic submissions this provides an opportunity to do some initial submissions very quickly to get experience.

 

 

Contact your Professional Services representative for detailed guidance regarding the implementation of the eMDR feature. The following procedures in this document define the system functional capabilities needed to generate an HL7 compliant xml file for your submission to the FDA. The FDA has changes in how they are requesting information be submitted electronically versus in the physical reporting world, and there are choices on how you can do the actual electronic submission to the FDA ESG.

 

Scenario 1 - WebTrader

 

 

SmartComplaintsTM generates an eMDR HL7 compliant, xml file. The customer enters Web Trader and submits the eMDR file. Web Trader is a front end B2B that submits the file to the FDA ESG. The FDA returns a message and the reporter receives notification and enters Web Trader to review the message. The reporter then manually updates the complaint submission acknowledgement table with FDA information.

The Complaint Synchronization Agent (CSA) cannot retrieve information from Web Trader and send it back to SmartComplaintsTM. Web Trader is a public free access to the FDA gateway, therefore, you cannot install your company specific software as an integration.

 

Scenario 2 – B2B without CSA (Complaints Synchronization Agent)

 

 

SmartComplaintsTM generates an eMDR HL7 compliant, xml file. The users B2B can pick-up the file from a network location, encrypt and then submit it to the FDA ESG. The user can use their own B2B to store the FDA acknowledgements and generate reports to determine if all three acknowledgements have been received and if the final one is PASSED. This scenario will not use the Complaint Synchronization Agent to input the information automatically into the SmartComplaintsTM acknowledgement table.

 

Scenario 3 – B2B with CSA (Complaints Synchronization Agent)

 

 

SmartComplaintsTM generates an eMDR xml file, your B2B retrieves the file and submits it to FDA ESG. FDA ESG sends messages back to the B2B which places a call to the Complaints Synchronization Agent to update the complaint submission acknowledgement table with the FDA information.

 

Scenario 4 – Using a Call to the CSA to Retrieve eMDR

 

 

SmartComplaintsTM sends data to an output table. The B2B listens for eMDR notification of availability, and calls CSA to retrieve the eMDR xml file and submit it to the FDA. The FDA returns information and the B2B places a call to the Complaints Synchronization Agent to update the Complaint Submission Acknowledgement table with FDA information.

 

eMDR Definitions

Term

Description

3500A MedWatch

Medical Device Adverse Event Mandatory Report for Manufacturer, User Facilities and Importers.

 

eMDR

Electronic Medical Device Adverse Event Reporting for the FDA (CDRH).

 

FDA ESG

Food and Drug Administration Electronic Submissions Gateway. This is an FDA agency-wide entry point for all electronic submissions. It routes the submissions to the appropriate center or office.

 

FDA CDRH

Food and Drug Administration Center for Devices and Radiological Health.

 

HL7

Health Level 7. This is an ANSI accredited Standards Development Organization (SDO), which is a not for profit volunteer organization that develops standards and specifications related to healthcare. The most widely used standard is a messaging standard that enables disparate healthcare applications to exchange key sets of clinical and administrative data. Additional information may be found at www.Hl7.org.

 

ICSR

Individual Case Safety Report. This is a message or report that contains all the information from an adverse event. The ICSR message is specifically designed to support individual case safety reports, and does not support population-based case reporting for disease surveillance or outbreak events. In addition, the message is designed to support international safety reporting between public health organizations such as the World Health Organization, and regulatory authorities in the US, Canada, Europe, Japan and other countries.

The HL7 ICSR message Release 1 (normative edition2005) supports the exchange of data and other safety reporting requirements between various public health and patient safety organizations. The eMDR release implements Release 1 of the ICSR; additional releases of this ICSR format will add additional reporting requirements in the future.

 

NCI Thesaurus

The National Cancer Institute (NCI) thesaurus is a product of NCI's Enterprise Vocabulary Service (EVS), which is a collaborative effort of the NCI Office of Communications and the NCI Center for Bioinformatics. It is built so that both humans and computers can interpret it.

Published by NCI, this knowledge base contains the working vocabulary used in NCI data systems. It covers clinical, translational and basic research as well as administrative terminology. The CDRH ICSR team worked with terminology experts from the NCI EVS to identify the majority of vocabulary for MDR’s.

 

AS2

Applicability Statement 2. An electronic gateway to gateway submission protocol that uses HTTP/HTTPS for communications. This is the required protocol that must be used by customers using the B2B transport mechanism to submit to the FDA ESG.

 

 

 

Numbering Scheme

Please see Numbering Scheme under System Wide Setup.

 

 

Submission Status

Please see Submission Status under Manual Reporting Setup

 

 

Regulatory Reporting Policy

The Regulatory Reporting Policy is used for eMDR to:

·         Enable eMDR submission capability.

·         Define the MDR submission numbering scheme.

·         Define the eMDR xml output file naming convention and directory location.

 

Please see Regulatory Reporting Policy under Manual Reporting Setup

 

 

FDA eSubmission Link

In the Submission tab of the complaint record there is an FDA eSubmission hyperlink. This link, out of the box, sends the user to the FDA ESG test environment. This link can be configured to go to the FDA ESG production environment, once CDRH testing is completed. This link is configurable for one URL, is not driven by any policy, and is effective for all Submission tabs.

 

 

How to Edit the FDA eSubmission URL

The location of the URL may need to be changed if you are using WebTrader and you need to change the link from your test to production account. Please follow the steps below to change the URL.

1.     Access the following folder location:

Application Name\SubmissionForms\Formconfig.xsl

<RegulatoryBody Name="FDA" SubmissionUrl="https://esgtest.fda.gov/">

2.     Change the URL to the FDA ESG production URL received from the FDA.

 

How to Rename the FDA eSubmission Link

If you wish to change the name of the link to better suite your end user (for example, “Click to Launch WebTrader”), then follow the steps below>

1.     Access the culture file.

2.     Export the culture file from the Language Translator.

3.     Open the file and then translate it using the SubmissionUrl.

4.     Import the culture file back into the application.

 

</data>

  <data name="SubmissionUrl">

            <value>FDA eSubmission</value>

      </data>

 

How to Remove the FDA eSubmission Link

If a B2B solution is being used and the URL needs to be removed from the page, it can be removed with the following configuration.

The existing tag is:

<RegulatoryBody Name="FDA" SubmissionUrl="https://esgtest.fda.gov/">

To remove the hyperlink from the page remove the URL from the expression:

<RegulatoryBody Name="FDA" SubmissionUrl="">

 

 

MedWatch PDF Template

 

How to Access the MedWatch PDF on the Server

Please see How to Access the PDF on the Server under Manual Reporting Setup.

 

How to Map Fields from the Complaint to the PDF

Please see How to Map Fields from the Complaint to the PDF under Manual Reporting Setup.

 

How to Enable | Disable Follow-up Report Data

Please see How to Enable | Disable Follow-up Report Data under Manual Reporting Setup.

 

How to Rename Your Company on the PDF

In the MedWatch PDF Report, the default Out of the Box PDF says Your Company.

Please see How to Rename Your Company on the PDF under Manual Reporting Setup.

 

 

MedWatch HTML Template

 

MedWatch 3500A Data Entry Design Conditions

The Data Entry Template can be loaded from the Submission folder as long as eMDR is enabled in the regulatory reporting policy. The following rules apply to the template:

·         The MedWatch eSubmission data entry template captures all the MedWatch data so that the xml file output is compatible with FDA requirements. All labels are identical in naming to the MedWatch form.

·         Every section is collapsible.

·         All sections of the MedWatch form, required for medical device customers to submit as an eMDR, are available via the template.

·         Section C for drugs is not available.

·         Field lengths are validated in the template. For example, A1 is a maximum of 10 digits so the system won’t allow users to enter more.

·         Dates – mm/dd/yyyy format is required for all dates, which is different than manual submission per FDA. If mm/yyyy is entered the system will automatically apply 01= dd for submitting to the FDA.

·         Formats are defined in tool tips as instructions or in the label. Tooltips can be modified if needed.

·         Drop down fields help guide user answers. All drop down values are specifically defined by the FDA and should not be changed.

·         Client side validation is applied to zip codes and phone numbers. A red icon identifies incorrectly formatted information.

·         Note that the labels have format instructions. 

·         State codes are defined by the US Postal Service.

·         Country codes are defined by ISO 3166 Standard.

·         Anytime incomplete or incorrect data is entered, the date entry template displays the errors and indicates what must be fixed. Click the error message and it will take you to the error (as long as the section is open).

·         Every field label has its own unique instruction. Instructions that are specific to eMDR guide the user in entering data.

 

Null Values

ASKU

Asked but unknown. Answer could be available but no information was provided.

NI

No information. No information is available for this field.

NA

Not applicable. This question does not apply to the situation.

 

Overview of Data Flow

 

 

eMDR Folder Definitions

The table below shows the folders that have been added to support the eMDR feature that IT departments may need to access during the implementation stage.

Folder

Description

eMDRHL7

Contains the Impl_Files/Con061019.xsd” that is the default schema that the FDA is using to validate their information.

 

NOTE: Do note edit or remove this folder.

 

FDAERRORFILE

If there is an error when completing the submission, the system creates an error that is displayed on the user's screen and an xml file is created in this folder. The xml file name is the same as the complaint number.  

This is the file you should submit to Pilgrim's Customer Support Center if you cannot determine what the error is caused from.

 

NOTE: Do not edit or remove this folder.

 

FDAXML

Default Location for the FDA xml file.

·         B2B will need access to this directory for submitting reports to the FDA.

·         Regulatory submitter requires access to submit reports to the FDA Web Trader.

 

NOTE: The system can be configured to export the file to other locations.

 

 

Transfer of Data from HTML to PDF

Transferring the data from HTML to PDF is a two step processes:

1.   Using the 3500aHTMLXPath.XML to extract the data from the HTML and using the skeleton of file 3500aFormTemplate.XML, we assign the value in the file 3500aFormTemplate.XML.

2.   Using the file 3500aFormTemplate.xml with the data, we transfer the data back to the PDF.

 

Application Name\SubmissionForm\FormConfig.xml

 

 

How to Access XSLT for eMDR HTML from the Server

The HtmlXSLT=”3500aFormHtml.xsl” file is used to map the data fields from the complaint record to the data entry template.

In the template below:

·         Patient Information is considered a Section

·         A1, A2, A3, A4 is considered a Group

·         Age at Time of Event is considered a field

 

Wor85D

 

Application Name\SubmissionForm\FormConfig.xml

 

You then need to go to:

Application Name\SubmissionForm\3500aFormHtml.xsl

 

How to Change the Default Path for eMDR XML

The eMDR xml file is copied to the DefaultPath= FDAXML folder when eSubmission is selected in the Submission tab of the complaint record.

FDAXML is a new folder for the output of the xml default folder.

 

How to Change the File Naming Convention for eMDR XML

DefaultFormat="{0}-CDRH-eMDR.xml" is the default naming convention used for all eMDR xml files that are created and by default stored in the FDAXML file folder. This default file naming convention can be overwritten in the unique regulatory reporting policy created for each registration site. This is the default applied to all the eMDR xml files.

 

Application Name\SubmissionForm\FormConfig.xml

 

Default file name for eMDR xml output file that is stored in the FDAXML folder

In the Submission tab look for the Submission Method column. Once you have submitted the eMDR an Acknowledgement hyperlink appears. Select the hyperlink to display the file.

This naming convention displays under the Acknowledgements hyperlink. You can check here quickly to see the immediate impact if you change the name.

 

Wor853

 

How to Configure Section Labels

Changes

Description

 

Section Title Name

Change individual section titles by changing the value of the “Name”:

<SECTION_NAME>A. PATIENT INFORMATION</SECTION_NAME>

 

Section Instructions

Change individual section instruction by changing the value of “instruction” , this is a tool tip:

<SECTION_INSTRUCTION>Instruction for A. PATIENT INFORMATION</SECTION_INSTRUCTION>

<SECTION_SHOW_INSTRUCTION>True</SECTION_SHOW_INSTRUCTION>

 

Make Section Visible

Make Individual section visible by changing the value of “visible”:

<SECTION_VISIBLE>True</SECTION_VISIBLE>

 

 

How to Configure Group Labels

Changes

Description

Group Name

Change the Group Name by changing the value of “Name”:

 <GROUP_NAME>A1</GROUP_NAME>

 

Group Instruction

Change individual group instruction by changing the value of “instruction”, this is a tool tip:      

<GROUP_INSTRUCTION>Instruction for Group A</GROUP_INSTRUCTION>

 

Show Group Instruction

Show Group instruction

<GROUP_SHOW_INSTRUCTION>False</GROUP_SHOW_INSTRUCTION>

 

Make Group Visible

Make Individual group visible by changing the value of “visible”:

<GROUP_VISIBLE>True</GROUP_VISIBLE>

 

Change Group Order

Order of the group

<GROUP_SORTORDER>1</GROUP_SORTORDER>

 

 

How to Configure Field Labels

Changes

Description

Field Name

Change the Field Name by changing the value of “Name”:

    <SINGLEVALUE_FIELD_NAME>Patient Identifier</SINGLEVALUE_FIELD_NAME>

 

Field Instruction

Change individual Field instruction by changing the value of “instruction”, this is a tool tip:  

    <SINGLEVALUE_INSTRUCTION> Instruction for patient field.</SINGLEVALUE_INSTRUCTION>

 

Show Field Instruction

Show Field instruction:

   <SINGLEVALUE_SHOW_INSTRUCTION>False</SINGLEVALUE_INSTRUCTION>

Make individual Field visible by changing the value of “visible”:

   <SINGLEVALUE_VISIBLE> True</SINGLEVALUE_VISIBLE>

 

Change Field Order

Order of the Fields:

   <SINGLEVALUE_SORTORDER> 1</SINGLEVALUE_SORTORDER>

 

Change Field to Text, Memo, Dropdown, or Checkbox

Each Field can be a: Text, Dropdown, Memo or Checkbox:

   <SINGLEVALUE_COLUMN_TO_SHOW>DROPDOWN</SINGLEVALUE_COLUMN_TO_SHOW>

 

Disable Field or make Field Modifiable

Each Field can be modifiable=True or read only if=False:

   <SINGLEVALUE_MODIFIABLE>False</SINGLEVALUE_MODIFIABLE>

 

Make Field Required or Optional

Each Field can be required or not:

  <SINGLEVALUE_REQUIRED>False</SINGLEVALUE_REQUIRED>

 

Show SmartSolve Data

To show the Smart Solve data for the follow up report:

  SINGLEVALUE_NOTINFOLLOWUP>True</SINGLEVALUE_NOTINFOLLOWUP>

 

 

How to Configure Text Fields

Changes

Description

Change Maximum Character Length

Maximum number of characters that can be entered, for example:

<SINGLEVALUE_TEXTBOX_MAXLENGTH>10</SINGLEVALUE_TEXTBOX_MAXLENGTH>

 

Change Field Size

Size of the Textbox that is viewable for entering data:

<SINGLEVALUE_TEXTBOX_SIZE>15</SINGLEVALUE_TEXTBOX_SIZE>

 

Add Zoom Field

If the zoom control needs to be added then add the following and where it is zooming to:

 <SINGLEVALUE_ZOOMTO>Calendar</SINGLEVALUE_ZOOMTO>

If the data needs to be validated at the client side using regular expression (NOTE: these are standard .net expressions that can be used and are not Pilgrim specific):

<SINGLEVALUE_MASK>(^\d{3}\(\d{3}\)\d{3}\-\d{4}$)|(^\d{3}\(\d{3}\)\d{3}\-\d{4}(x)\d{1,5}$)|(NA)|(NI)|(ASKU)</SINGLEVALUE_MASK>

 

Add Default Data into Text Field

For example the out of the box code for A1 is shown below as:

<SINGLEVALUE_TEXTBOX_VALUE />

It needs to be replaced with the following expression to default “NA” into the text box field.

<SINGLEVALUE_TEXTBOX_VALUE>NA</SINGLEVALUE_TEXTBOX_VALUE >

 

 

How to Configure Drop Down Fields

Changes

Description

Change Maximum Character Length

What value you want to show in the drop down has to have a value in the “3500aVOCAB.xml  file.

<SINGLEVALUE_DROPDOWN_FILTER_VALUE>Answer</SINGLEVALUE_DROPDOWN_FILTER_VALUE>

 

Add Default Data into Dropdown Field

For example, the Out of the Box code for D9 “Country” field is shown below as:

<SINGLEVALUE_DROPDOWN_VALUE />

It will need to be replaced with the following expression to default “UNITED STATES” into the drop down field.

<SINGLEVALUE_DROPDOWN_VALUE>UNITED STATES</SINGLEVALUE_DROPDOWN_VALUE>

 

 

NOTE: this is for any fields which do not contain SmartComplaintsTM data.

 

Add Default Data into Dropdown Field – SmartComplaints Data transferred

For example the Out of the Box code for D3 “Country” is shown below as:

<SINGLEVALUE_DROPDOWN_VALUE><xsl:value-of select="Complaint/MANUFACTURER_ADDRESS/PHY_COUNTRY" /></SINGLEVALUE_DROPDOWN_VALUE>

It will need to be replaced with the following expression to default “UNITED STATES” into the drop down field.

<SINGLEVALUE_DROPDOWN_VALUE>UNITED STATES</SINGLEVALUE_DROPDOWN_VALUE>

 

 

NOTE: this is for any fields which contain SmartComplaintsTM transferred data.

 

Default Age Dropdown to Years

<SINGLEVALUE>

         <SINGLEVALUE_ID>A2_Age</SINGLEVALUE_ID>

         <SINGLEVALUE_FIELD_NAME>Age at Time of Event</SINGLEVALUE_FIELD_NAME>

         <SINGLEVALUE_INSTRUCTION>If patient is 3 years or older</SINGLEVALUE_INSTRUCTION>

         <SINGLEVALUE_PARENT_GROUP_ID>A2</SINGLEVALUE_PARENT_GROUP_ID>

         <SINGLEVALUE_TEXTBOX_VALUE />

         <SINGLEVALUE_DROPDOWN_VALUE>YR</SINGLEVALUE_DROPDOWN_VALUE>

         <SINGLEVALUE_CHECKBOX_VALUE>0</SINGLEVALUE_CHECKBOX_VALUE>

         <SINGLEVALUE_FINAL_VALUE />

         <SINGLEVALUE_COLUMN_TO_SHOW>TEXTBOX | DROPDOWN</SINGLEVALUE_COLUMN_TO_SHOW>

         <SINGLEVALUE_TEXTBOX_MAXLENGTH>5</SINGLEVALUE_TEXTBOX_MAXLENGTH>

         <SINGLEVALUE_TEXTBOX_SIZE>6</SINGLEVALUE_TEXTBOX_SIZE>

         <SINGLEVALUE_TEXTBOX_FORMAT_TYPE />

         <SINGLEVALUE_REQUIRED>False</SINGLEVALUE_REQUIRED>

         <SINGLEVALUE_ZOOMTO />

         <SINGLEVALUE_DROPDOWN_FILTER_VALUE>YearUnit</SINGLEVALUE_DROPDOWN_FILTER_VALUE>

         <SINGLEVALUE_MODIFIABLE>True</SINGLEVALUE_MODIFIABLE>

         <SINGLEVALUE_VISIBLE>True</SINGLEVALUE_VISIBLE>

         <SINGLEVALUE_SORTORDER>5</SINGLEVALUE_SORTORDER>

         <SINGLEVALUE_MASK>(^\d{1,5}$)|(NA)|(NI)|(ASKU)</SINGLEVALUE_MASK>

</SINGLEVALUE>

 

Use the YearUnit conversion in the Vocabulary file so that the correct dropdown value is selected.

The VOCABULARY3500A.xml file has the concept code you need to enter in the default dropdown field above.

  <Table>

    <CodeSystem>YearUnit</CodeSystem>

    <ConceptCode>YR</ConceptCode>

    <ConceptPreferredTerm>Years</ConceptPreferredTerm>

  </Table>

 

Default Weight Dropdown to Pounds

Replace                  <SINGLEVALUE_DROPDOWN_VALUE />

With the following          <SINGLEVALUE_DROPDOWN_VALUE>lbs</SINGLEVALUE_DROPDOWN_VALUE>

 

<SINGLEVALUE>

<SINGLEVALUE_ID>A4_Weight</SINGLEVALUE_ID>

            <SINGLEVALUE_FIELD_NAME>Patient Weight</SINGLEVALUE_FIELD_NAME>

            <SINGLEVALUE_INSTRUCTION>Enter the weight and select the appropriate unit of measure. Make a best estimate if exact weight is unknown.</SINGLEVALUE_INSTRUCTION>

            <SINGLEVALUE_PARENT_GROUP_ID>A4</SINGLEVALUE_PARENT_GROUP_ID>

            <SINGLEVALUE_TEXTBOX_VALUE />

            <SINGLEVALUE_DROPDOWN_VALUE>lbs</SINGLEVALUE_DROPDOWN_VALUE>

            <SINGLEVALUE_CHECKBOX_VALUE>0</SINGLEVALUE_CHECKBOX_VALUE>

            <SINGLEVALUE_FINAL_VALUE />

            <SINGLEVALUE_COLUMN_TO_SHOW>TEXTBOX | DROPDOWN</SINGLEVALUE_COLUMN_TO_SHOW>

            <SINGLEVALUE_TEXTBOX_MAXLENGTH>3</SINGLEVALUE_TEXTBOX_MAXLENGTH>

            <SINGLEVALUE_TEXTBOX_SIZE>4</SINGLEVALUE_TEXTBOX_SIZE>

            <SINGLEVALUE_TEXTBOX_FORMAT_TYPE />

            <SINGLEVALUE_REQUIRED>False</SINGLEVALUE_REQUIRED>

            <SINGLEVALUE_ZOOMTO />

            <SINGLEVALUE_DROPDOWN_FILTER_VALUE>UOM</SINGLEVALUE_DROPDOWN_FILTER_VALUE>

            <SINGLEVALUE_MODIFIABLE>True</SINGLEVALUE_MODIFIABLE>

            <SINGLEVALUE_VISIBLE>True</SINGLEVALUE_VISIBLE>

            <SINGLEVALUE_SORTORDER>5</SINGLEVALUE_SORTORDER>

            <SINGLEVALUE_MASK />

</SINGLEVALUE>

 

The VOCABULARY3500A.xml file has the concept code you need to enter in the default dropdown field above.

  <Table>

    <CodeSystem>UOM</CodeSystem>

    <ConceptCode>lbs</ConceptCode>

    <ConceptPreferredTerm>Pounds</ConceptPreferredTerm>

  </Table>

 

Capture Sex of Patient from Complaint Field to HTML Template Dropdown

In the complaint page a user defined field was used to capture the sex of the patient as shown below:

To map female or male to the correct dropdown in the eMDR template below:

<SINGLEVALUE>

            <SINGLEVALUE_ID>A3_SEX</SINGLEVALUE_ID>

            <SINGLEVALUE_FIELD_NAME>Patient Sex</SINGLEVALUE_FIELD_NAME>

<SINGLEVALUE_INSTRUCTION>Select the patient's gender from the dropdown list. If the adverse event is a congenital anomaly, report the sex of the child.</SINGLEVALUE_INSTRUCTION>

            <SINGLEVALUE_PARENT_GROUP_ID>A3</SINGLEVALUE_PARENT_GROUP_ID>

            <SINGLEVALUE_TEXTBOX_VALUE />

                        <xsl:choose>

                                    <xsl:when test="normalize-space(Complaint/V_CEX_CXP_EXTENSION/CEX_UDF_STRING_1) = 'Male'">

                                    <SINGLEVALUE_DROPDOWN_VALUE>Male</SINGLEVALUE_DROPDOWN_VALUE>

</xsl:when><xsl:when test="normalize-space(Complaint/V_CEX_CXP_EXTENSION/CEX_UDF_STRING_1) = 'Female'">

                                    <SINGLEVALUE_DROPDOWN_VALUE>Female</SINGLEVALUE_DROPDOWN_VALUE>

                                    </xsl:when>

                        </xsl:choose>

            <SINGLEVALUE_CHECKBOX_VALUE>0</SINGLEVALUE_CHECKBOX_VALUE>

            <SINGLEVALUE_FINAL_VALUE />

            <SINGLEVALUE_COLUMN_TO_SHOW>DROPDOWN</SINGLEVALUE_COLUMN_TO_SHOW>

            <SINGLEVALUE_TEXTBOX_MAXLENGTH>5</SINGLEVALUE_TEXTBOX_MAXLENGTH>

            <SINGLEVALUE_TEXTBOX_SIZE>6</SINGLEVALUE_TEXTBOX_SIZE>

            <SINGLEVALUE_TEXTBOX_FORMAT_TYPE />

            <SINGLEVALUE_REQUIRED>False</SINGLEVALUE_REQUIRED>

            <SINGLEVALUE_ZOOMTO />

            <SINGLEVALUE_DROPDOWN_FILTER_VALUE>SexType</SINGLEVALUE_DROPDOWN_FILTER_VALUE>

            <SINGLEVALUE_MODIFIABLE>True</SINGLEVALUE_MODIFIABLE>

            <SINGLEVALUE_VISIBLE>True</SINGLEVALUE_VISIBLE>

            <SINGLEVALUE_SORTORDER>5</SINGLEVALUE_SORTORDER>

            <SINGLEVALUE_MASK />

</SINGLEVALUE>

 

 

How to Configure Checkbox Fields

Changes

Description

Auto Check a Check box

A checkbox unchecked would show as:

<SINGLEVALUE_CHECKBOX_VALUE>0</SINGLEVALUE_CHECKBOX_VALUE>

It will need to be replaced with the following expression to default the checkbox with a check.

<SINGLEVALUE_CHECKBOX_VALUE>1</SINGLEVALUE_CHECKBOX_VALUE>

 

 

How to Verify Field Limits in Template Fields

Use this when you are mapping data from the complaint record to the HTML.

FDA eMDR has field limitations per the HL7 ICSR version 1 requirements.

Always use the GetFixLengthData command when bringing over information. This allows the appropriate length of information to be brought over initially. If it is not used, the user will get an error message when they submit the eMDR. This is because it will be validated to the FDA eMDR schema file that is checked before loading into the MAUDE database.

If the field size in SmartSolve is greater than in the eMDR, you should only map for certain character length. Below is the sample of the mapping that has been done when SmartSolve© size is greater than eMDR size.

File Name : 3500aFormHtml.xsl

Field Name : D1_BrandName

<SINGLEVALUE_TEXTBOX_VALUE>

      <xsl:value-of select="ssext:GetFixLengthData(Complaint/V_CXP_CUSTOMER_PXP/CXP_BRAND_NAME,80)" />

</SINGLEVALUE_TEXTBOX_VALUE>

 

How to Verify Field Limits in SmartComplaints Fields

To find the size of the data fields in SmartComplaintsTM:

·         Access the DDF/ERD documents on Disc 2 of the last SmartSolve© major release CD.

OR

·         Open a view and look at the columns to find the data field size and type. 

 

How to Map Fields from Complaint to the HTML

Data fields can be mapped:

·         from the Complaint record to the MedWatch PDF form

·         from the Complaint record to the data entry template

·         from the HTML template to the MedWatch PDF form

The fields below are mapped to the eMDR report. This means Title, State, and Country map into the Medwatch report for the Medwatch template. The fields are drop down fields and must be selected exactly. They can be configured to allow any input and the system will insert the correct information into the HTML template for the MedWatch report. If fields aren’t auto populating into your template, contact your IT Administrator who can configure the system so the correct information is entered.

 

Example Fields to be Mapped

Fields, Folders, Tabs

Description

State

State must be populated with either the capitalized 2-digit US Postal State Code or capitalized full state spelling. For Example, user will submit either AZ or ARIZONA so that it populates correctly into the form.

 

Country

Country must be populated with either the fully capitalized country name (based on the ISO 3166 standard), for example UNITED STATES, UNITED KINGDOM, CANADA. The following other countries have been configured out of the box: US, us, USA, usa, United States, united states, United States, INDIA, NEPAL.

 

Title

Title will populate into a field that has drop down values that the FDA requires for submission. The customer can configure these defaults.

Note: IT can configure the State, Country and Titles so that they can comply with the standards already in use by the customer.

 

 

The following views can be used to map fields into the html or pdf forms:

Data Fields

Views

 

CustomerComplaint

V_CXP_CUSTOMER_PXP

AdditionalInfo

V_CEX_CXP_EXTENSION

SerialNumbers

V_PXS_PXP_SERIAL

Attachments

V_BAH_BASE_ATTACH_QXP

Contacts

V_CMC_CXP_CONTACT

Part

V_EPA_EXCEPTION_PART

Lots

V_EPL_EXCEPTION_PART_LOT

Submissions

V_BAH_BASE_ATTACH_CXP

GetInvestigationResult

V_BTK_BASETASK

References Tab | External  Reference

Complaint/V_EXR_EXTERNAL_REFERENCE/EXR_REFERENCE_VALUE

 

NOTE: Each data field in the complaint record is associated with a specific view; basically use the prefix of the data field to find the appropriate view name to use in your expressions. For Example, If you want to use a user defined field, CEX_UDF_STRING_2 and map it over you will need to use the view: V_CEX_CXP_EXTENSION

 

 

Examples of Standard Mapping Tables

The data fields below are examples of the types of data fields that have been mapped over from the complaint record into the HTML template:

1.     Physical Address of OrgUnit (m_objComplaint.OrgUnitID) (ORG_UNIT): ORGUNIT_ADDRESS

2.     Physical Address of Report site(BAH_VIGL_RPTSTE_ID): RPTSITE_ADDRESS

3.     Physical Address of Manufacture: MANUFACTURER_ADDRESS ( for Site: CEX_MFCTR_SITE_ID)

4.     Distributor/Importer: IMP_DISTR_SITE_ADDRESS (CEX_IMPRT_DISTRB_ID)

5.     Importer/Distributor Contact Info (BAH_IMP_DISTR_CONT_ID Distributor Contact) : IMP_DISTR_CONTACT

6.     Vigilance contact Info  (BAH_VIGL_RPTSTE_CONT_ID )  : VIGL_RPTSTE_CONTACT

7.     Manufacture Contact Info( BAH_MFCT_CONTACT_ID): MFCT_CONTACT

 

Scenario

Configuration

 

This Scenario brings over the short description and then the description text.

 

<SINGLEVALUE>

<SINGLEVALUE_ID>B5_DescribeEvent</SINGLEVALUE_ID>

<SINGLEVALUE_FIELD_NAME>Describe Event or Problem (Required field for eSubmission.)</SINGLEVALUE_FIELD_NAME>

<SINGLEVALUE_INSTRUCTION>For an adverse event: Describe the event in detail using the reporter's own words, including a description of what happened and a summary of all relevant clinical information (medical status prior to the event; signs and/or symptoms; differential diagnosis for the event in question; clinical course; treatment; outcome, etc.). </SINGLEVALUE_INSTRUCTION>

            <SINGLEVALUE_PARENT_GROUP_ID>B5</SINGLEVALUE_PARENT_GROUP_ID>

            <SINGLEVALUE_TEXTBOX_VALUE />

            <SINGLEVALUE_MEMO_VALUE>

                        <xsl:value-of select="Complaint/V_CXP_CUSTOMER_PXP/QXP_SHORT_DESC" />

                        <xsl:value-of select="string(' ')" />

                        <xsl:value-of select="Complaint/V_CXP_CUSTOMER_PXP/QXP_DESCRIPTION" />

            </SINGLEVALUE_MEMO_VALUE>

            <SINGLEVALUE_DROPDOWN_VALUE />

            <SINGLEVALUE_CHECKBOX_VALUE>0</SINGLEVALUE_CHECKBOX_VALUE>

            <SINGLEVALUE_FINAL_VALUE />

            <SINGLEVALUE_COLUMN_TO_SHOW>MEMO</SINGLEVALUE_COLUMN_TO_SHOW>

            <SINGLEVALUE_TEXTBOX_MAXLENGTH>6000</SINGLEVALUE_TEXTBOX_MAXLENGTH>

            <SINGLEVALUE_TEXTBOX_SIZE>4000</SINGLEVALUE_TEXTBOX_SIZE>

            <SINGLEVALUE_TEXTBOX_FORMAT_TYPE />

            <SINGLEVALUE_REQUIRED>True</SINGLEVALUE_REQUIRED>

            <SINGLEVALUE_ZOOMTO />

            <SINGLEVALUE_DROPDOWN_FILTER_VALUE />

            <SINGLEVALUE_MODIFIABLE>True</SINGLEVALUE_MODIFIABLE>

            <SINGLEVALUE_VISIBLE>True</SINGLEVALUE_VISIBLE>

            <SINGLEVALUE_SORTORDER>5</SINGLEVALUE_SORTORDER>

            <SINGLEVALUE_MASK />

            <SINGLEVALUE_NOTINFOLLOWUP>True</SINGLEVALUE_NOTINFOLLOWUP>

</SINGLEVALUE>

 

This scenario shows how to Get External Reference Value (Get Value)

   <SINGLEVALUE>

            <SINGLEVALUE_ID>A1_PatientIdentifier</SINGLEVALUE_ID>

            <SINGLEVALUE_FIELD_NAME>Patient Identifier (In confidence)</SINGLEVALUE_FIELD_NAME>

<SINGLEVALUE_INSTRUCTION>The Patient identifier can be 10 alpha/numeric characters long. Provide the patient's initials or some other type of identifier that will allow both the submitter and the initial reporter (if different) to locate the case if contacted for follow-up. Do not use the patient's name or social security number. The patient's identity is held in strict confidence by FDA and protected to the fullest extent of the law.</SINGLEVALUE_INSTRUCTION>                                                            <SINGLEVALUE_PARENT_GROUP_ID>A1</SINGLEVALUE_PARENT_GROUP_ID>

             <SINGLEVALUE_TEXTBOX_VALUE>

                        <xsl:value-of select="Complaint/V_EXR_EXTERNAL_REFERENCE/EXR_REFERENCE_VALUE" />

            </SINGLEVALUE_TEXTBOX_VALUE>

            <SINGLEVALUE_DROPDOWN_VALUE />

            <SINGLEVALUE_CHECKBOX_VALUE>0</SINGLEVALUE_CHECKBOX_VALUE>

            <SINGLEVALUE_FINAL_VALUE />

            <SINGLEVALUE_COLUMN_TO_SHOW>TEXTBOX</SINGLEVALUE_COLUMN_TO_SHOW>

            <SINGLEVALUE_TEXTBOX_MAXLENGTH>10</SINGLEVALUE_TEXTBOX_MAXLENGTH>

            <SINGLEVALUE_TEXTBOX_SIZE>15</SINGLEVALUE_TEXTBOX_SIZE>

            <SINGLEVALUE_TEXTBOX_FORMAT_TYPE />

            <SINGLEVALUE_REQUIRED>False</SINGLEVALUE_REQUIRED>

            <SINGLEVALUE_ZOOMTO></SINGLEVALUE_ZOOMTO>

            <SINGLEVALUE_DROPDOWN_FILTER_VALUE />

            <SINGLEVALUE_MODIFIABLE>True</SINGLEVALUE_MODIFIABLE>

            <SINGLEVALUE_VISIBLE>True</SINGLEVALUE_VISIBLE>

            <SINGLEVALUE_SORTORDER>5</SINGLEVALUE_SORTORDER>

            <SINGLEVALUE_MASK />

  </SINGLEVALUE>

 

 

How to Rename ‘Your Company’ on the Template

In the eMDR template, the default out of the box PDF says Your Company. It needs to be changed to the corporate name for the company. This setup is configured once and will populate into all the eMDR data entry templates.

Wor846

 

1.     Access the folder - Application Name\SubmissionForms\3500aFormHtml.xsl

2.     Change Your Company to the name to be used for your MedWatch Reporting.

Wor84A

 

 

Country Codes

 

ISO 3166 Trigraph Standard for Country Codes

The FDA will only accept the 3 digit country code in the xml file that is submited. It uses the HL7 Standard to create an ICSR version 1 message format.

·         HL7 is the Health Level 7 Standard used when writing the xml code that is required to be submitted.

·         ICSR is at version 1, it is the INDIVIDUAL CASE SAFETY REPORT message format. It is the “roadmap” used to create the correct xml file to be submitted.

·         The ICSR format says the name of the “tags” in the xml file and what needs to go inside of the tags.

·         The 3500A form is a physical form and the submission of that form is an xml file.

 

If users have a contact management system in place, the standards used in that system for case and abbreviations may not be configured to the Pilgrim off the shelf solution for country or state codes. Out of the box Pilgrim provides the ability to configure any formats for any country and state through use of the translation file.

The translation file is a configurable tool that helps users work within the variation of country naming conventions within their company. By allowing the variability to be managed within the translation file, the information can flow consistently from the Complaint record to the eMDR template, so that the correct country name can be selected and transferred to the template so the user does not have to re-select the country name.

The following type of configurable code has been included in the 3500aFormHtml.xsl file as an example of what can be done.

 

<xsl:template name="GetCountry">

  <xsl:param name="CountryParam" />

                           <xsl:choose>

  <xsl:when test="$CountryParam='US'">UNITED STATES</xsl:when>

  <xsl:when test="$CountryParam='us'">UNITED STATES</xsl:when>

  <xsl:when test="$CountryParam='USA'">UNITED STATES</xsl:when>

  <xsl:when test="$CountryParam='usa'">UNITED STATES</xsl:when>

  <xsl:when test="$CountryParam='United States'">UNITED STATES</xsl:when>

  <xsl:when test="$CountryParam='united states'">UNITED STATES</xsl:when>

  <xsl:when test="$CountryParam='UNITEDSTATES'">UNITED STATES</xsl:when>

  <xsl:when test="$CountryParam='India'">INDIA</xsl:when>

  <xsl:when test="$CountryParam='Nepal'">NEPAL</xsl:when>

 <xsl:otherwise>

  <xsl:value-of select="$CountryParam" />

 

How to Enter More Supported Countries

If the user needs to support more countries, they can access the file and enter all the various combinations for the countries needed.

1.     Access the form - Application Name\ SubmissionForms\3500aFormHtml.xsl

2.     Go to the end of the file (do a search on GetCountry).

3.     Access the configurable code and enter all the variations for each country, making sure to get the correct country name from the 3500aVOCAB.xml file.

NOTE: This is additional configuration supported for countries; however, the more you add to the file the longer the search will take when creating the eMDR template.

 

 

Wor86C

 

NOTE: When mapping fields from the complaint record to the eMDR template use getfixlength. Transferring fields that are too long truncates the fields going into the eMDR template for the out-of-the-box mapped fields.  

 

 

 

State Codes

States are configured similarly to countries. Users should run a report to see how codes are currently entered in their database. The translation file is a configurable tool that helps users work within the variation of state naming conventions within their company. By allowing the variability to be managed within the translation file, the information can flow consistently to the eMDR template so that the correct state name can be selected and transferred to the eMDR template and then finally to the xml file..

State must be populated with either the capitalized two-digit US postal state code or capitalized full state spelling. For Example, either AZ or ARIZONA so that it populates correctly into the form.

To support more states, access the file and enter all the various combinations for the states needed:

Application Name\ SubmissionForms\3500aFormHtml.xsl

For the State, out of the box Pilgrim supports FL and IL. To support more:

Application Name\SubmissionForms\3500aFormHtml.xsl .

 

How to Configure State Codes

1.     Go to function GetState and add more conditions.

2.     Access the configurable code and enter all the variations for each state making sure to get the correct country name from the 3500aVOCAB.xml file.

Below are the out-of-the-box definitions:

</xsl:template>

- <xsl:template name="GetState">

  <xsl:param name="StateParam" />

- <xsl:choose>

  <xsl:when test="$StateParam='AL'">ALABAMA</xsl:when>

  <xsl:when test="$StateParam='AK'">ALASKA</xsl:when>

  <xsl:when test="$StateParam='AS'">AMERICAN SAMOA</xsl:when>

  <xsl:when test="$StateParam='AZ'">ARIZONA</xsl:when>

  - <xsl:otherwise>

  <xsl:value-of select="$StateParam" />

  </xsl:otherwise>

 

 

CDRH Codes

Please refer to the CDRH Event Code website for more information on CDRH Codes as regulated by the FDA for device, pharma, and patient codes.

 

User Rights

The following rights must be assigned to a user to manage or view CDRH Codes:

Rights

Description

HDR_IMPORT

Allows administrator to Import CDRH Codes.

 

HDR_MANAGE

Allows administrator to Manage CDRH Codes.

 

HDR_DELETE

Allows administrator to Delete CDRH Codes.

 

HDR_VIEW

Allows user to access CDRH Codes to View and Select.

 

 

Please see Rights Groups to assign Rights Groups to users

 

Global vs. Local

Global CDRH codes should be managed from the global organization and all local organizations will inherit these codes.

NOTE: do not import CDRH Codes into a Local Organization.

 

 

 

How to Import CDRH Codes

CDRH codes can be imported into SmartComplaintsTM. These codes are used in the FDA MedWatch report.

NOTES:

Full text search should be installed/setup. This way codes can be imported and enabled.

Before importing CDRH Codes, obtain the FDS spreadsheet from the CDRH Event Codes web page.

 

 

1.   From the SmartSolve© tabs select Admin > Setup. Select Regulatory Terms in System Wide.

The Regulatory Terms window displays.

2.   From the menu select Action > Import CDRH Codes.

3.     In the FileTo Import field, click Browse and select the xls file to import.

4.     Click Save.

5.     To check that the file imported correctly, select the hyperlink labeled CDRH and the system will provide the same search mechanism to view the terms.

 

NOTE: Current design uses the CDRH spreadsheet as the file to import with the newest codes.

 

 

Managing CDRH Code Data

CDRH Codes can be enabled, deleted, and managed accordingly by an administrator.

 

How to Enable CDRH Codes

After CDRH codes are setup, the codes must be enabled for users. The system uses the last Created Date that is enabled.

1.     From the SmartSolve© tabs select Admin > Setup. Select Regulatory Terms in System Wide.

The Regulatory Terms window displays.

The system will use the latest imported created dictionary that is Enabled to present to the users when they are searching on CDRH event codes.

2.     From the menu select Action > Enable.

3.     The Dictionary Enabled field for the item now says Yes and the Enabled date is documented.

 

How to Delete CDRH Codes

If needed, CDRH Codes can be deleted from the system.

1.     From the SmartSolve© tabs select Admin > Setup. Select Regulatory Terms in System Wide.

The Regulatory Terms window displays.

2.     Check off the CDRH Codes to remove from the system

3.     From the menu select Action > Delete.

4.     Select Ok to confirm the delete.

The CDRH Codes have been removed from the system.

 

Submission Codes

The Submission Code Table contains FDA codes from the FDA website.

Submission Codes need to go through a strict change control mechanism. If users upgrade to codes that do not meet the FDA approved codes the eMDR submission will fail at Acknowledgement 3. Submission codes should not be changed, however, those codes that are not needed may be deleted.

The following Codes can be setup under the Submission Code setup table for SmartComplaintsTM:

·         Conclusion Codes

·         Method Codes

·         Result Codes

·         Product Codes

 

User Rights

The following rights must be assigned to a user to manage or view Submission Codes:

Rights

Description

CSC_MANAGE

Allows administrator to add new Submission Codes, modify existing Codes, or delete Codes.

 

CSC_VIEW

Allows user to access Submission Codes to view and select.

 

 

Please see Rights Group to assign Rights Groups to users

 

Global vs. Local

      Global Submission Codes will be inherited by all local organizations. 

NOTE: do not create Submission Codes in a Local Organization.

 

 

How to Create Submission Codes

1.   In SmartComplaintsTM, access the submission code table under the GLOBAL Organization using Admin > Setup. Select Submission Code from Exception/Issue.

The Submission Codes display.

2.     Click Action | Add to add codes to the table. Enter codes as found on the FDA website.

3.     Enter information in the following fields:

Field

Description

Code Type

Click the drop down button and select the type of code to be added.

 

Code

Enter the code number for the submission code, as defined by the FDA.

 

Name

Enter the name of the submissions code as defined by the FDA.

 

Description

Enter a description for the code.

 

4.     Click the Save button.

 

Managing Submission Code Data

Submission codes can be edited, deleted, and managed accordingly by an administrator.

 

How to Edit Submission Codes

1.   From the Global SmartSolve© tabs select Admin > Setup. Select Submission Code from Exception/Issue.

The Submission Codes display.

2.  Select the check box of the Submission Code to edit, then select Action > Edit from the main menu (or right click).

3.    Edit any information for your Code.

4.     Click the Save button.

All changes should now be reflected in the list.

 

How to Delete Submission Codes

1.     From the Global SmartSolve© tabs select Admin > Setup. Select Submission Code from Exception/Issue.

The Submission Codes display

2.   Select the check box of the Code to delete, then select Action > Delete from the main menu (or right click).

3.     Click the Save button.

The object has now been removed from the system