Change Request FAQ

A change request is a process used by core subscribers to suggest an addition, relocation, or correction of a MedDRA term. A 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 is added to MedDRA when it meets all of the following criteria: must be unambiguous, within scope of the terminology, and must be 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 before being incorporated into MedDRA.

When you purchase a core services subscription, you receive your Change Request ID, User ID, and Password. You may go to the Change Request Information section of our web site. The preferred method to submit change requests is via the web change request 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 form. An example of how to fill out the 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@ngc.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.

Simple change requests should complete processing in 7 to 10 working days, unless additional research is needed. In these cases requester should receive notice of this action within the 7 to 10 day timeframe. Complex changes can be submitted anytime, but they are only considered for inclusion into MedDRA once a year.

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.

Each change request submitted to the MSSO is assigned a CR Number and the Final Notification report is sent indicating the outcome of the particular change request. Subscribers may use WebCR (Subscriber login required) to track the progress of your submission, review the history of a term, verify a term in MedDRA, or resubmit a rejected term for reconsideration. Additionally, subscribers may reference the Supplemental Changes section of the web site and conduct a search based on either CR Number or on the wording of a term to view terms accepted into MedDRA.

A Core subscription includes a monthly allocation of 100 simple change requests.

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

Yes. A change request is counted against the subscriber's remaining simple 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.

The change request process consists of steps to ensure the simple change request originates from a valid MedDRA core level subscriber, is complete and is a simple change. The simple change request must be unambiguous, within scope, meet guidelines for making simple 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 validated as medically correct and verified by an international panel of medical personnel before being incorporated into MedDRA. A series of quality control checks are performed throughout the process before a change is accepted to MedDRA. A simple change request that fails to meet any of these 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.