The purpose of this site is to help coders, data managers, CRAs and all persons involved in clinical trials, to find some very useful information concerning the coding of clinical data in relation to drug therapy.
Coding conventions, medical expertise and coding review experience are often needed to check that the data are coded appropriately and consistency. Also, the persons in charge of coding must be familiar with current dictionaries and the international guidelines.
Pharmaceutical manufactures are encouraged to set up coding rules and guidelines when using medical terminologies. This is particularly recommended for the MedDRA dictionary. A guidelines document “points to consider” was created to help pharmaceutical manufacturers, clinical investigators and other users achieve consistency in the manner in which they assign terms when using MedDRA. It is currently available for comment through the MedDRA Maintenance and Support Services Organization (MSSO) homepage http://www.meddramsso.org.
The Points to Consider document is an ICH-endorsed guide for MedDRA users. It is designed to be updated based on MedDRA changes, and is a companion document to the MedDRA Terminology. It has been developed by the MedDRA and maintained by a working group charged by the ICH steering committee consisting of regulatory and industry representatives of the European Union, Japan and the United States, as well as representatives from Canada, the MedDRA Maintenance and Support Services Organization (MSSO), and Japanese Maintenance Organization (JMO).
The objective of coding rules and guidelines is to promote medical accuracy and consistency when using a controlled vocabulary to share clinical safety data across the European Union, Japan and the United States. Coding Rules are those coding standards that are necessary and require coding practices that have been agreed upon by representative members of the data management, Pharmacovigillance, clinical and statistic departments. Everyone is expected to follow these "Coding rules".
Coding Guidelines are “suggested coding practices” that have been written to recognize and harmonize the need for individuality, and for common international coding practices. The purpose of the guidelines is to provide a framework to foster consistent use of a standard terminology for data input and retrieval. However, the guidelines are not meant to impede coders efforts when these guidelines are found to be in direct conflict with a therapeutic area’s preference, so long as that preference is implemented consistently and is well documented.
The following suggestions should be considered when setting up coding conventions:
• The coding working group should include representative members of Pharmacovigilance, Data management and clinical departments. • Coding conventions should be detailed in 2 or 3 levels if necessary (General and/or specific area and/or specific study conventions). • A summary of coding process and dictionary updates should be included in the final document. • The conflicts with the International coding guidelines should be documented. • The coding conventions should be applied and respected • The coding conventions use should promote accuracy and consistency • The coding conventions should be explained to all persons involved in the use, implementation and maintenance of MedDRA.