Change Requests

This document is intended to assist subscribers in understanding how to submit change requests to the MSSO. It describes how to interpret disposition reports, provide tips on submitting changes, and give guidelines on how to fill out the change request forms. This document is applicable for simple changes, complex changes, and SMQ changes.

Change Request Information Document (.pdf)

WebCR is an on-line tool used for submitting (non SMQ) change requests. In addition to submitting requests, WebCR provides the following features:

• Review the history of a term
• Verfiy a term in MedDRA
• Resubmit a term for consideration
• Track the progress of your submission and hold it or submit it when you are ready.

See the WebCR Quick Reference (.pdf) for getting started with using Web CR.

The MSSO will continue to accept your change requests on the change request form. Please email completed change request forms to:  mssorequest@ngc.com , or fax them to: +1 703.272.5635. Should you have questions, please contact our help desk at mssohelp@ngc.com , or +1 877.258.8280.

SMQ Change Requests

Subscribers wishing to submit an SMQ change request must use the SMQ change request form.

Note: For each request for a new SMQ, please answer the following questions in your justification field:

1. What is the scientific/pharmacovigilance question that led to the request for this SMQ?
2. Is the current MedDRA hierarchy (e.g., HLTs, PTs) or any existing SMQ suitable to address the question? If not, what are the deficiencies in the hierarchy or existing SMQs that should be addressed?
3. Would your organization be able to address this question without this new SMQ, and if so, how? (That is, what would be the strategy and terms used?)
4. Which SMQ structure (i.e., broad/narrow, hierarchical, algorithm) do you think would best address the question?
5. How often would your organization need this SMQ (e.g., only once to address a very specific emerging issue or regularly/routinely)?

Please email completed translation correction change request forms to: mssorequest@ngc.com, or fax them to: +1 703.272.5635.

Correcting Translated MedDRA Terms

Subscribers wishing to submit corrections to translated terms (e.g., MedDRA Spanish, MedDRA French, etc.) must use the Translation Correction Change Request Form.

For questions about the Japanese translation, please contact the Japanese Maintenance Organization.

Please email completed change request forms to: mssorequest@ngc.com, or fax them to: +1 703.272.5635.