Master Coding Dictionary

medical terminology used in pharmaceutical and medical product development must adhere to standardized dictionaries these dictionaries can be uploaded to rave once uploaded, a coding dictionary can be applied to a field when an edc end user enters data into the coding dictionary field, the system will attempt to automatically code the data to an entry in the coding dictionary if the system does not find a match, an edc end user can search for the correct code in the dictionary there are a few items to be noted about coding dictionary fields multiple coding dictionaries can be uploaded to rave; however, only one coding dictionary may be applied to any given field coding dictionaries cannot be used with data dictionaries, unit dictionaries, or lab fields coder settings before configuring coder settings, the coding dictionaries must be registered for the rave study specified on the coder project registration page this is not configured via the als make a note of the dictionary names coding dictionaries are defined in properties at asset group level variable coding to define codings for assets open the asset that requires coding then select the medidata rave tab under properties select the required dictionary in the coding dictionary property or click add coder configuration complete the following coding level the value entered here depends on the dictionary for example, within meddra, the hierarchy levels in descending order are system organ class (soc) high level group term (hlgt) high level term (hlt) preferred term (pt) lower level term (llt) is auto approval specify whether approval is automatic for this coder configuration is approval required specify whether approval is required for this coder configuration locale specify the local for this coder configuration for example, ‘en us’ priority assigns the relative priority of for the coding task coder supplemental terms allow you to map additional fields from rave edc either to identify drug components when using the whodrug dictionary, or to pass additional data, such as patient sex or age, for use in the coding task adding supplemental terms can narrow the search and may help return faster results it is optional to link supplemental terms to a coding field note supplemental terms must be taken from fields on the same rave form as the coder verbatim text field component terms used to map additional fields from rave edc to identify drug components when using the whodrug dictionary or other coding dictionaries that have terms associated with components or drug information adding component terms can narrow the search and may help return faster results it is optional to link component terms to a coding field