What Is It?

Target Encoder® is a secure, USER FRIENDLY, web-based coding tool, to code CRF terms to MedDRA and WHODRUG. Once CRF terms are inputted into the System, each CRF term is searched in the designated MedDRA or WHODRUG database. The system automatically codes perfect matches.

If multiple matches are found, the system gives a list of possible matches. The user can select a match from the list. The manually entered term is then added to the user-defined dictionary. If no matches are found, the coder manually refines the term to match it with an appropriate term. Once this match is made, it is placed into the user-defined dictionary. All manual coding can be reversed and a list of automatically and manually coded terms are presented as a report.

A glossary is also provided for all uniquely coded terms.

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How It Works

Once CRF terms are inputted into the System, each CRF term is searched in the MedDRA WHO-DRUG databases. If a single match is found, the System accepts it. If multiple matches are found, the system gives a list of possible matches. The user can select a match from the list. The manually entered term is then added to the UDD. If no matches are found, the coder manually matches the term to the appropriate lower level term (LLT) through either a keyword search or a drill-down procedure starting from the SOC. Once this match is made, it is placed into the UDD.

Prior to putting a coded term in the UDD, the coder has the option to decide if this manually coded term is to be used as a default term for all subsequent coding or must be manually coded each time a new CRF term with that name is identified.

Once the LLT is chosen, there is an associated unique preferred term (PT). Each preferred term has a unique associated high level term (HLT) and high level group term (HLGT) and a primary system organ class (pSOC). The SOC itself can be a unique term or can be chosen from a list of several SOC terms. The system needs to be able to default to the pSOC or allow the user to pick the SOC, if there is more than one.

Once a CRF term is either automatically coded or is put into the UDD, it is considered coded.

The user must have the option to override a automatic or manually coded term when patient specific information indicates that a different MedDRA term should be used. When this is done, the term is considered coded and should not change during a subsequent coding procedure.

The following reports are generated by the System:

• List of terms added to the user-defined dictionary
• A listing of just unique terms (verbatim, LLT, PT, and SOC in an Excel spreadsheet). This listing does not require validation and will be transmitted as an Excel spreadsheet.
• Verbatim term, LLT, PT and SOC.
  • The listing should be in an Excel spreadsheet so that it can be sorted, organized by patient number/ID
  • The listing must indicate those terms that were autoencoded vs. those that did not autoencode and the suggested coding.
  • The listing should indicate terms that are coded by the user vs. those that were only modified (as a result of a query or change requested by sponsor).