New MedDRA Subscriber Information

The following is basic information that will guide you to make full use of your MedDRA subscription.

• MedDRA is released twice a year (1 March and 1 September)
• You should have received your User ID, Password, Change Request Password (CRID), MedDRA Web-Based Password, and Unzip Password.
  
  
  o The User ID and Password will be necessary to enter the subscriber sections of the MSSO Web site.
  
  o The MedDRA Release files are stored in a protected zip file. The Unzip Password allows subscriber to extract the MedDRA Release files onto his/or her computer. The Unzip Password is case sensitive, version specific, and translation specific.
  
  o The User ID and CRID will be necessary to submit change requests (e.g., add a term to MedDRA, change an existing term) to the MSSO.
  
  o The User ID and MedDRA Web-Based Password will be necessary to access the MedDRA Web-Based Browser.
• The MSSO provides a free MedDRA Desktop Browser to view and search MedDRA (see the question below to get the MedDRA Desktop Browser).
• The MSSO provides a free MedDRA Web-Based Browser to view and search MedDRA (see the question below to get the MedDRA Web-Based Browser).
• Please refer to the MedDRA Frequently Asked Questions (FAQs) for more information.

All documents and data files referenced below may be found on the Downloads section of the web site.

Name	Type	File name & suffix (type)	Description Summary
MedDRA ASCII files	Terminology	*.asc	The MedDRA database / terminology files / List and content of the current Production SMQ data structure
MedDRA Consecutive files	Terminology	*.seq	Delta between current and previous release by individual record
MedDRA Introductory Guide	Supporting documentation	intguide.pdf	Guidelines & conventions for use of MedDRA broken down by System Organ Class
Introductory Guide for SMQs	Supporting documentation	SMQ_ intguide.pdf	Summary document listing guidelines & conventions for use of SMQs
MedDRA ASCII and Consecutive Files Documentation	Supporting documentation	ASCII_seq_datafiles.pdf	Explanation of the MedDRA terminology ASCII (flat file) and SEQ file data structure
What's New documentation	Supporting documentation	whatsnew.pdf	Text highlights of current release, established conventions, and updates on hot topics; include statistical data for the release
ReadMe	Supporting documentation	!!readme.pdf	Summary of release content; also appears in internet file download set
Release Detail Report	Supporting documentation	DetailReport.pdf	Contains a listing of all change requests considered for the current version of MedDRA
Version Reports	Supporting documentation	VersionReports.xls	Detailed reports with specific lists of terms with changes since the latest release in a pliable .xls format
SMQ Production Spreadsheets	Supporting documentation	SMQ_Spreadsheet.xls	SMQ production spreadsheets for the latest release in a pliable .xls format

The MedDRA Release files are distributed in sets of flat ASCII delimited files. The documentations accompanying the terminology are in PDF and excel format. The flat ASCII files can be loaded into all of the commonly used database management systems (e.g., MS Access ®, MS SQL Server ®, Oracle®). All software applications commonly used in the pharmaceutical industry can either load MedDRA directly or through a load utility.

To download the MedDRA Release Files, please follow the steps below:

1. Navigate to www.meddramsso.com
2. Click on Current Subscriber and then select Downloads
3. Please login when the login prompt appears
4. Under Current Release Version of MedDRA, please select MedDRA ##.# Data and Documentation
5. Click on the desired MedDRA terminology translation
6. Save the zipped file (which contains the MedDRA Release files) to your hard drive
7. Extract the files to as directory on your computer
8. When prompted for Password – enter the applicable Unzip Password

The MedDRA Desktop Browser 3.0.1b (MDB3) is a complimentary software application that has been developed using the Microsoft Windows®.Net™ 2.0 platform. It has been developed to be compatible with Windows XP® Professional SP2 and intended for download on individual work stations only.

To download the MDB3, please follow the steps listed below:

1. Uninstall any older versions of the MedDRA Browser (if applicable).
2. Navigate to the MedDRA Desktop Browser on the MedDRA Desktop Browser download page.
3. Save the MDB3 zipped file (which contains the MDB3 setup file and the User Manual) to your hard drive.
4. Extract the files to a directory on your computer.
5. Double-click the extracted file named MedDRABrowserSetup.msi and follow the on-screen instructions to install v3.0beta of the MedDRA Desktop Browser.

The MedDRA Web-Based Browser is provided by the ICH MedDRA Management Board to all MedDRA MSSO subscribers as part of their MedDRA subscription. The MedDRA Management Board hopes that the MedDRA Web-Based Browser will be of added value and will help to further facilitate the use of MedDRA.

• MedDRA Web-Based Browser


• MedDRA Web-Based Browser Help

Support from the MedDRA MSSO

The MedDRA MSSO team will be pleased to assist you should you have any inquiries or require technical assistance with the MedDRA Web-Based Browser.

MedDRA MSSO Telephone and E-mail:

Toll Free International: +1 877.258.8280

Direct: +1 703.272.5505

Fax: +1 703.272.5635

E-mail for Help Desk: mssohelp@ngc.com