M11 - Clinical electronic Structured Harmonised Protocol (CeSHarP) Related Files

ICH M11 OID list and ICH code lists 
 

An Object Identifier, or OID, is a construct used to identify an object. In the context of IT standards OIDs are globally unique identifiers. The OID values have been assigned for each required code list or namespace by the ICH M2 EWG in partnership with the ICH M11 EWG. These OIDs provide unambiguous and clear identification of the code lists used – always referring to a distinct object. 

For detailed information about OIDs, please refer to an information paper published by M2. Link to the M2 information paper for OIDs and UUIDs.  

There are many elements within the M11 that require specific codes to reference defined values. These may be impacted over time by changes in the regulatory environment. By separating the code lists from the M11 technical specifications and guideline, it becomes easier for code lists to be adapted, should this be necessary, without altering the technical specifications itself or requiring a new version of it. Also, technical systems can be more readily maintained if the code lists are provided in a clearly identified, traceable manner. 

Step 4 ICH M11 Package 

To download the package click here