- How to Use
A MedDRA “Change Request” (CR) allows a MedDRA user to recommend the addition of new term, changes to existing terms, or improvements in the structure of MedDRA. These changes to MedDRA may help the user code and analyse data more accurately. MedDRA users may request up to 100 CRs per month.
The diagram below shows the process flow for CRs submitted to the MSSO.
MedDRA users can submit different types of change requests. Simple change requests are processed with each release of MedDRA and include changes to the LLT and PT levels of MedDRA. Complex changes are processed once a year and include changes above the PT level at the HLT, HLGT, and SOC levels of MedDRA. Users may also submit change requests related to Standardised MedDRA Queries (SMQs). Change requests for SMQs include adding PTs to SMQs or making existing PTs in SMQs inactive or requesting a new SMQ. Lastly, users can submit change requests related to any of the translated versions of MedDRA.
WebCR is an online tool used for submitting CRs to the MSSO. WebCR supports all types of change requests described above: MedDRA changes, SMQ changes and Translation corrections. In addition to submitting requests, WebCR provides the following features:
- Verify if an English term exists in MedDRA
- Review when an English term was added to MedDRA
- Search the history of all change requests considered by the MSSO since MedDRA Version 5.1
- Resubmit a rejected request for reconsideration
- Track the progress of submitted requests
- Hold proposed CRs and submit them when ready
See the WebCR Quick Reference guide for getting started with using WebCR.
The MSSO also performs proactive maintenance (making corrections or improvements without receiving specific change requests from users). For example, proactivity changes can relate to making more general changes to MedDRA – perhaps correcting a series of outdated terms or addressing an area of inconsistency.
Freeze Dates for Submitting Change Requests
1 December (for March release)
1 June (for September release)
Contact the JMO for changes to Japanese translation