(Updated: May 2008)
What is MedDRA?
The Medical Dictionary for Regulatory Activities (MedDRA) has
been developed as a pragmatic, clinically validated medical terminology
with an emphasis on ease-of-use data entry, retrieval, analysis,
and display, with a suitable balance between sensitivity and specificity,
within the regulatory environment. MedDRA is applicable to all
phases of drug development and the health effects of devices.
By providing one source of medical terminology, MedDRA improves
the effectiveness and transparency of medical product regulation
worldwide.
What are uses for MedDRA?
MedDRA is used to report adverse event data from clinical trials, as well as post-marketing and pharmacovigilance.
How should MedDRA be
cited in publications?
The following are guidelines for the use of MedDRA in publications:
MedDRA text terms may be used in examples, but the examples need to be limited in size (less than 100 terms). MedDRA numeric codes are not permitted to be used.
It should be cited in the article that MedDRA® the Medical Dictionary for Regulatory Activities terminology is the international medical terminology developed under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
The following acknowledgement statement needs to appear in all articles referencing MedDRA: MedDRA® is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).
Copies of all articles referencing MedDRA should be emailed to MSSOHelp@ngc.com.
What
are the structural elements of the terminology in MedDRA?
The structural elements of the MedDRA terminology are as follows:
- SOC - Highest level of the terminology, and distinguished by anatomical or physiological system, etiology, or purpose
- HLGT – Subordinate to SOC, superordinate descriptor for one or more HLTs
- HLT – Subordinate to HLGT, superordinate descriptor for one or more PTs
- PT – Represents a single medical concept
- LLT – Lowest level of the terminology, related to a single PT as a synonym, lexical variant, or quasi-synonym (Note: All PTs have an identical LLT).
In what format
is MedDRA distributed?
MedDRA is distributed in sets of flat ASCII delimited files. There is a different set of files for each available language. The Czech translation is distributed in UTF-8 format. For detail information as to file names, data record scheme, and record layout, see the MedDRA ASCII and Consecutive Files Documentation document, which can be downloaded from the MedDRA MSSO Web site.
How do I load
MedDRA onto my system?
Because MedDRA is intended to be used on multiple platforms, we do not have specific information on loading MedDRA onto every user's specific system or platform. However, if you'll look at the ASCII File Documentation that comes with MedDRA, it gives some information on the table names, field names and attributes, table joins, etc., which are required to create a relational database (using any database product) with the distributed MedDRA files.
For assistance loading MedDRA ASCII files into the MedDRA Browser, please go to http://www.meddramsso.com/mssoweb/started/index.htm.
What
are hardware or software requirements to operate MedDRA?
MedDRA does not have any specific hardware or software requirements. It does not require any particular operating system or version of an operating system, such as Windows NT®. The terminology is delivered as a set of ASCII text files. The documentation accompanying the terminology is in .pdf format and describes the relationships between the files, which can then be used to load the files into a database or software application. The MedDRA text files can be loaded into all of the commonly used database management systems (e.g., MS Access ©, Oracle®). All software applications commonly used in the pharmaceutical industry can either load MedDRA directly or through a load utility.
How Large are the MedDRA ASCII Files?
MedDRA is delivered in text file format. As of MedDRA Version 11.1, the total size of all ASCII files for the English version is 12,459KB.
What is the status of MedDRA translations currently available?
Czech, Dutch, French, German, Italian, Portuguese, Spanish, and MedDRA/J (Japanese) MedDRA translations are currently available on the web site for downloading using your User ID, Password, and Unzip password.
When are MedDRA translations made available?
The English versions of MedDRA are made available on 1 March and
1 September of each year. Available EU and Japanese translations of MedDRA are made available two weeks after the English version, or approximately 15 March and 15 September.
What is the difference between the MedDRA English version and Japanese version?
The concept and contents of the Japanese version of MedDRA are exactly the same as English. Due to language, culture, and medical practice, differences between the Japanese and English MedDRA versions exist. The Japanese version of MedDRA, like other translations, contains duplicate translations of terms at the LLT level. However, MedDRA/J provides an additional J-currency field to ensure the MedDRA/J "current" terms are flagged as unique. See http://www.meddramsso.com/MSSOWeb/meddraj/currency.htm for more of an explanation of the MedDRA/J currency criteria.
Does MedDRA do drug product coding?
Drug coding is out of the scope of MedDRA. There are terminologies
designed specifically for coding drugs and chemicals that would
assist you in this type of coding.
What
can you provide as additional information regarding companies'
implementation of the latest version of MedDRA within 60 days
of its availability?
The MSSO advises a single change-over date when the new version
of MedDRA becomes effective; the first Monday of the second month
after the release date is advised.
What are the
recent changes to MedDRA?
Access to the details of these changes will require
the use of the User ID and Password. Changes in MedDRA
may be found in two places:
1) What's New supporting document found in the Downloads > MedDRA Terminology section of the web wite
2) Changes within the version are posted on the Supplemental
Changes section in the Downloads section of the web site
Will MedDRA continue to maintain the Special Search Categories?
With the advent of the more sophisticated Standardised MedDRA Queries, the current SSCs within MedDRA will no longer be maintained or distributed. The MSSO has archived the existing SSC files. These files are available for download at http://www.meddramsso.com/MSSOWeb/mssosubs/SSC_Update.htm (Subscriber login required). Please note that the SSCs are based upon linkages at the PT level and that in each subsequent version of MedDRA, PTs may be demoted, and new PTs may be added to better represent the PT concept. Therefore, if you use the archived SSC files with a version other than 9.1, there may be terms that are no longer linked to the SSC as they were in Version 9.1. Subsequently, the SSC may no longer find the same cases as they did in Version 9.1.
What is the
status of ICD-9 in MedDRA?
ICD-9© was not fully implemented in the original version of MedDRA
2.1, and what was implemented was not implemented consistently.
Since ICD-9 is copyrighted by World Health Organization, the MedDRA
Management Board agreed not to make any changes to ICD-9 codes in MedDRA.
Some ICD-9 codes are assigned to several LLT codes or PT codes. Can you confirm that in these cases LLT and PT MedDRA codes are all identical to the ICD-9 code values, and different MedDRA code values will appear only at higher hierarchical MedDRA levels?
One ICD-9 concept can be linked to multiple MedDRA terms at multiple
levels. The user needs to be aware that equivalencies between the two
(ICD-9 and MedDRA codes) are based on concepts and not string
matches.
Will the ICD-9 links to MedDRA be updated to the current MedDRA version?
There are no plans to update the ICD-9 to MedDRA; however, the MSSO
has one year after the official release of ICD-10-CM to provide
a crosswalk to MedDRA terms.
When
will MedDRA accommodate the National Cancer Institute's (NCI) Common
Toxicity Criteria (CTC)?
The MSSO has worked with CTEP to establish a mapping between CTCAE and MedDRA V9.0 LLTs. You can download the mapping at http://www.meddramsso.com/translations/downloads.htm. The mapping will be updated in March each year.
When
will the FDA mandate use of the MedDRA?
The rule to
mandate the use of MedDRA has been published in the Federal
Register for comment.
My company operates
in the U.S., so why do I have to use MedDRA if the FDA has not
made a ruling?
MedDRA is an international medical terminology designed to support the classification, retrieval, presentation, and communication of medical information throughout the medical product regulatory cycle. Since November 1997, the FDA has replaced its Spontaneous Reporting System ( SRS ) and the Coding Symbols for Thesaurus of Adverse Reaction Terms ( COSTART © ) Terminology with the new Adverse Events Reporting System ( AERS ) and the MedDRA Terminology. The use of MedDRA is inevitable since the
rule to mandate the use of MedDRA was in the OMB office and the 90-day review period was up in mid-November 2002. To date, the mandate regarding the use of MedDRA is still a part of the proposed rule for post-marketing reporting.
Are there
any FDA regulations or policies concerning the use of the primary
System Organ Class (SOC) allocation of individual terms for adverse
event reporting, for either pre-marketing or post-marketing reports?
Is there any documentation to support this directive?
Currently, there are no published FDA regulations or policies concerning the use of the primary System Organ Class ( SOC ) allocation of individual terms for either pre-marketing or post-marketing adverse event reports. The understanding that MedDRA was built by consensus between regulators and industry representatives means that the establishment of criteria for the primary allocation of Preferred Terms (PTs) was a consensus decision.
Using the Primary SOC allocation:
- Decreases the risk of double counting events in cumulative
outputs (when using secondary SOC allocations, there is the
potential for finding multiple instances of the same event scattered
over a number of SOCs, which may be confusing)
- Provides for consistent representation of specific events
between companies and regulators (as MedDRA is a standard terminology)
- Allows secondary SOC allocations to be used for other types
of scientific analyses.
The MSSO is not certain about what the "final" rules and regulations will be concerning this issue. However, we recommend that if users choose to use a secondary SOC allocation for individual terms, they should be able to produce the term under the primary SOC allocation in the event of a regulatory inquiry. Additionally, regulators from other regions are starting to request reports using only the primary SOC path.
The primary SOC allocation is what is expected and recommended when using an internationally accepted, standardized terminology, but users also have the option of providing documentation as to why they believe the secondary SOC allocation might better represent their data; this documentation should be submitted to the MSSO in the form of a Change Request to change the primary SOC allocation for a specific term. Some companies set up their systems to either view all SOC allocations, or through pilot conversions, set it up to view the secondary SOC allocations. However, the MSSO would advise caution in this case. Click here (link to the “Points to Consider” Document under Document Library) for the "MedDRA Term Selection: Points to Consider" document, which refers to the recommendation to use the SOC assignments the way they are, and the procedures for correcting them through the Change Request process.
As a reminder, the "Points to Consider" document is an ICH -endorsed companion document for MedDRA which provides the user community with a standardized approach to term selection/coding with MedDRA.
Is there an
international agreement regarding the order in which MedDRA SOCs
should appear on Product Labeling?
There is an agreement to the international order of SOCs, which is included with each MedDRA release and can be found in either the Introductory Guide supporting document (Version Documentation) or in the Intl_ord.asc file.
On what date does a new MedDRA release need to be implemented? Do FDA and EMEA expect the users to recode all old cases or does implementation mean that the new cases and follow-ups should be coded with the new version?
As of right now, there is no required date by which regulators start using the next version of MedDRA. The post-market reporting document authored by the MSSO recommends that organizations update their systems with the latest version of MedDRA by 60 days after the release of MedDRA. This does not mean that all data must be re-coded, just that all organizations would start using the latest version of MedDRA. The EMEA has, in some cases, required users to recode data back to 1995.
During the 60 day period, it was envisioned that organizations would review the changes in MedDRA and make what changes they (the organization) thought were necessary. Typically, this involves reviewing and re-coding LLTs that have become non-current, reviewing new direct matches to the verbatims and, if resources allow, reviewing medical “better” terms. These steps are not required but are a typical "best practice" of many organizations.
Are there any restrictions on disseminating statistical reports to investigators outside our organization who were involved in a clinical trial?
Although the third party licensing agreement requires both a
Sponsor and a CRO to carry a MedDRA subscription, there are no
restrictions on disseminating statistical reports to investigators
outside your organization who were involved in a clinical trial.
In this case, the intent is of a business nature and not to distribute
the MedDRA terminology. The MSSO realized that MedDRA codes sometimes
appear in this data.
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