(Updated Sep 2007)
What
is a change request and what are the types of change requests?
A change request is a process used by core subscribers to suggest an addition, deletion, relocation, or correction of a MedDRA term. A change request can be either a simple change request or a complex change request.
What
types of changes are considered simple change requests?
“Simple change requests” are any changes at the preferred term (PT) level and below in the MedDRA terminology structure. A simple change request will fall under any of the following categories:
- Add a preferred term
- Move a preferred term
- Demote a preferred term
- Add or delete a preferred term link to a high level term
- Add a lowest level term
- Move a lowest level term
- Promote a lowest level term
- Change the status of a lowest level term
- Add a new term
- Swap a preferred term with a lowest level term
- Link / Unlink a PT from HLT (Move between SOCs)
What
types of changes are considered complex change requests?
Any changes involving the "hierarchy," meaning the HLTs, HLGTs, or SOCs,
are complex changes to the MedDRA terminology. The MSSO will
consider complex changes based on input from subscribers or internal
analysis. A complex change request can fall under any of the following
categories:
- Addition of a new group used to represent a new medical entity or procedure
- Major change to grouping (e.g., new HLT)
- Extensive terminology changes (e.g., ICD-10 inclusion).
All complex changes to the terminology are made once a year.
Who
determines what terms are added to MedDRA?
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 medical personnel before being incorporated into MedDRA.
How do I request a
change to the terminology?
When you purchase a core services subscription, you receive your
Change Request ID, User ID, and Password.
You may go to the Downloads Area of our website to download
the Change Request
form. An example of how to fill out the form can be found
on the second tab of the actual download. A Change Request submission
is required to be on a Change Request Form and should be emailed to
MSSOrequest@ngc.com. All
data elements should be filled in and included in the Change Request.
How
do I submit a change request for SMQs?
Submitting a change request for an SMQ is essentially the same as
submitting any other type of change request except you would use the SMQ
Change Request Form. For specifics, see the Change Request Information
document which can be found either in the documentation with each MedDRA
version release or on the MSSO Web site at
http://meddramsso.com/MSSOWeb/mssosubs/coresubs/changereq_info.htm.
Are there additional resources to help
our organization submit change requests ?
There is a Change Request Information link on the web site
(Ref: http://www.meddramsso.com/MSSOWeb/mssosubs/coresubs/changereq_info.htm ) 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. Additionally, the Change Request Form and the SMQ Change Request Form can be found here.
Who may request a change?
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 make simple change requests. A “requester” refers to individuals within the organization in addition to the subscriber point of contact with authority to make simple change requests. Subscribing organizations may authorize requesters as they see fit.
When
can I expect to receive results of a simple change request?
Simple change requests should complete processing in 7 to 14 calendar
days, unless additional research is needed. In these cases requester
should receive notice of this action within the 7 to 14 day timeframe.
How do I check the
status of my change request?
Each request is assigned a unique identifier (called the Change Request or CR Number) that you must have when contacting the MSSO help desk to determine change request status. This number is provided to the requester in both the Receipt Notification and the Final Notification reports.
How do I check the outcome of my change request?
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. Additionally, subscribers may reference the Supplemental Changes (Ref: http://www.meddramsso.com/translations/downloads.htm ) 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.
If the outcome of a particular term is “Rejected”, it will appear in the Rejections section of the web site (Ref: http://www.meddramsso.com/MSSOWeb/mssosubs/coresubs/rejections.asp).
Is there a limit to how many change requests can be submitted?
A Core subscription includes a monthly allocation of 100 simple change requests.
Can a Core subscriber submit more change requests than the number allowed per month?
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.
Is a resubmitted
simple change request counted against the subscriber’s allocated simple change
requests for the month and year?
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 and supplemental files on the web site prior to submitting new change requests.
What is the change
request process for the MSSO?
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. 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.
My company is very small, so do my requests
to add terms to MedDRA receive the same consideration as a large pharmaceutical company?
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.
Are
all supplemental terms reflected in the new releases of MedDRA?
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.
When a PT or LLT term is changed between MedDRA versions, does the corresponding PT or LLT code change also?
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.
When will new SMQs be available ?
All SMQs go through a process of pre-production testing followed by actual production, which means they are approved for official use within the MedDRA terminology (also available on the web site). Please review the SMQ section of the MSSO Web site for up-to-date news and to access SMQs that are approved and posted."
These can be downloaded at http://www.meddramsso.com/Translations/translationDownloads.htm using your User ID and Password. To unzip the password-protected files, please use the Unzip password(s) for the MedDRA translation(s). Unzip passwords are sent to the designated point of contact for the subscription.
What has happened to "Phase II" SMQs?
“Phase II” refers to the time when pre-production Standardised
MedDRA Queries (SMQs) were made available to MedDRA subscribers for
initial database testing. Based on these phase II testing results,
SMQs were then re-evaluated (and sometimes changed) by the CIOMS
Working Group for SMQs. Following that step, SMQs were then
authorized by the Management Board for production use.
Once in production, the maintenance of SMQs is through the MSSO’s change
request process.
In July 2006, the MedDRA Management Board decided to end the phase II
part of SMQ development. Once an SMQ has been tested by the Working Group,
and after approval by the Board, it will be made available for full production
use for subscribers through the MSSO.
Does this mean that I cannot comment
upon the content and performance of an SMQ?
Once an SMQ goes into production, the change request process
goes into effect, i.e., subscribers will be able to request changes
to an SMQ in much the same way that they can submit changes to MedDRA
itself.
Additionally, the MSSO would like to have your feedback on SMQ content and file structure.
After an SMQ has been in production for 18 – 24 months, there will be a
review of all the changes made or proposed for the SMQ by members of the
CIOMS Working Group. This will provide a second level of oversight of
subscriber and MSSO-generated changes to assure the continued quality of SMQs.
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