Change Request FAQ

A change request is a process used by Core, Basic, and Regulatory subscribers to suggest an addition, relocation, correction of a MedDRA term, an SMQ change, or a correction to a term translated from English to one of the currently supported languages.

A MedDRA term change request can be either a simple change request or a complex change request.

Simple change requests are any changes at the preferred term (PT) level and below in the MedDRA terminology structure.

Any changes involving the hierarchy, meaning the high level terms (HLT), high level group terms (HLGT), or system organ classes (SOCs), are complex changes to the MedDRA terminology. The MSSO will consider complex changes based on input from subscribers or internal analysis.

Complex changes are made once a year.

The addition of terms to MedDRA is driven by the subscriber change request process. A term that has been submitted by a subscriber may be added to MedDRA if it meets all of the following criteria: must be within scope of the terminology, unambiguous, medically valid and internationally acceptable by an international panel of MSSO medical personnel, and must have a justification that explains the need for the term.

When you obtain a Core, Basic, or Regulatory services subscription, you will receive a Change Request ID, User ID, and Password. The Change Request Information section of our web site explains how to submit a change request. The preferred method to submit change requests is via the on-line change request submissions application, WebCR (Subscriber login required). The Subscriber ID serves as the user name and the Change Request ID is the password. The subscription password may also be used in lieu of the Change Request ID for read only access to WebCR. This is useful in situations where you want peers within your organization to review staged change requests, but not to submit them. Alternatively, the MSSO will accept Change Requests submitted via e-mail using the Change Request forms located on the Change Request Information section of the MSSO Web site. There is a separate form for each change request category (MedDRA term changes, SMQ changes, and Translation corrections). An example of how to fill out a form can be found on the second tab of the form. All change requests must be submitted via WebCR or the Change Request Form. If using the Change Request form to submit a change request, please send the completed form via e-mail to MSSOrequest@mssotools.com.

There is a Change Request Information section on our web site that provides step-by-step guidelines on how to submit changes, how to interpret reports from the MSSO, as well as other useful tips and hints.

MSSO accepts change requests from anyone with a valid User Identification Number (User ID) and Change Request Identification Number (CR ID). As the point of contact (referred to as subscriber) for MedDRA MSSO subscriptions, the subscriber may submit change requests. A requester refers to individuals within the organization in addition to the subscriber point of contact with authority to submit change requests. Subscribing organizations may authorize requesters as they see fit.

The results of submitted MedDRA term change requests should complete in 7 to 10 working days, unless additional research is needed. In these cases the requester will receive notice of this action within the 7 to 10 day timeframe.

Changes submitted immediately after the change request processing phase ends (Freeze date), usually 1 December and 1 June of each year, will be held until processing begins for the next version of MedDRA – approximately one month after the Freeze date.

Complex changes can be submitted anytime, but they are only considered for inclusion into MedDRA once a year.

The MSSO will process SMQ change requests and Translation correction requests as soon as possible, but cannot guarantee a specific completion timeframe due to the nature of these requests.

Each request is assigned a unique identifier (called the Change Request or CR Number), which is provided to the requester in both the Receipt Notification and the Final Notification reports e-mailed backed to the submitter. Subscribers may use WebCR (Subscriber login required) to track the progress of your submission. Alternatively, subscribers may contact the MSSO Help Desk to determine change request status.

The MSSO sends out a Final Notification report for each set of changes submitted which indicates the outcome of the each change request. Each change request is assigned a change request number to identify the specific request. Subscribers may use WebCR (Subscriber login required) to track the progress of submissions, review the history of a term, verify a term in MedDRA, or resubmit a rejected request for reconsideration. Additionally, subscribers may reference the Supplemental Changes section of the web site and conduct a search based on either change request number or on the wording of a term to view requests considered by the MSSO.

A Core, Basic, or Regulatory subscription includes a monthly allocation of 100 change requests, not including translation correction requests. There is no limit for translation correction requests.

No, the maximum number of change requests allocated per month for Core, Basic, or Regulatory subscribers is 100, not including translation correction requests. The MSSO recommends not holding change requests for this reason. Subscribers should be aware of the Freeze Date established for each version of MedDRA and plan to submit change requests accordingly.

Yes. A change request is counted against the subscriber's remaining change requests each time it is submitted. To alleviate duplicate requests, please review previously rejected requests via WebCR or supplemental files on the web site prior to submitting new change requests. Translation correction requests are not counted against the established submission limit.

The change request process consists of steps to ensure the change request originates from a valid MedDRA subscriber and is complete. The change request must be unambiguous, within scope, meet guidelines for making change requests to the terminology, and must be medically valid and internationally acceptable. The MSSO requires that an adequate justification accompany each change request, in order to be evaluated by the MSSO medical staff. Adequate justification means including a statement indicating why the term or change proposed is necessary, and may be supported by relevant definitions and other illustrative medical and scientific information. Each proposed change is evaluated by an international panel of medical personnel for incorporation into MedDRA. A series of quality control checks are performed throughout the process before a change is accepted into MedDRA. A change request that fails to meet any of the above criteria will be rejected by the MSSO and notification with a rationale for rejection will be sent to the requester. Rejected change requests will count against your annual/monthly change allocation.

Yes. When a change request submission is processed, no identification of the submitter is attached to the submission that could influence or create a bias for the International Medical Officers (IMOs), who must come to a consensus on the acceptance of the requested term; each request is determined on an individual basis without regard to the identity of the subscriber.

All supplementally approved terms are applied to the MedDRA database and assigned a MedDRA code. These codes remain supplemental until the next official release of MedDRA terminology. Supplemental terms may be viewed on the MedDRA Web site and are posted on a weekly basis.

If a PT or LLT term is renamed (only if stringent criteria have been met), the corresponding code remains the same. If a new PT or LLT term is added, then the corresponding code is also new.