Clinical Coding module

Recoding questions

The recoding feature enables you to compare already coded question responses against a newer version of the MedDRA dictionary.

The tool will identify all coded responses that are not coded against the latest dictionary, and then provide different options depending on whether the Low Level Term used is still present in the new dictionary, and is still marked as Primary or Current. You should work through all three steps in the recoding tool to ensure that all currently coded questions are compared.

Any change to a coded response is recorded in the clinical coding audit trail for the question.

Before recoding

Before starting, ensure that the following steps have been completed:

• In the Clinical Coding module, register the new version of the MedDRA dictionary.

• In the Study Definition module, open the question definition for each thesaurus question and select the new MedDRA version in the 'Thesaurus' field.

To recode the questions in a study

1. Log in to the Clinical Coding module.

2. Select File > Recode Responses. The Recode Responses window is displayed.

3. Select the study with which you want to work.

4. Check the 'Unfreeze/Refreeze' and 'Unlock/Relock' check boxes if you want to include frozen and locked responses in the search results. If you then choose to recode these responses during the recoding session, the response will be unfrozen/unlocked, the clinical coding status will be changed according to the choices you make below, and the response will be automatically refrozen/relocked.
   If these check boxes are unchecked, any frozen or locked responses will still be included in the list of responses found but they will not be recoded.
   Both check boxes will only be available if you have lock and freeze permissions for all levels (subject, visit, eForm and question).
   More info on how items are unlocked and unfrozen

   Locking and freezing cascades down from subject to visit to eForm to question so a response showing as locked or frozen may have been locked or frozen at any level. For example, if a visit is locked, all questions within it will automatically also be locked.

    

   If you choose to unlock and relock items as part of a recoding session, this locked visit would be unlocked, then each thesaurus question would be recoded, and then the visit would be relocked. If the same questions had originally been locked independently, then during the recoding session the visit would not be affected and each question would be unlocked, recoded and then relocked.
   If you choose to recode a response that is both locked and frozen, the unlocking occurs before the unfreezing. For example, the recoding process for a locked question within a frozen subject is as follows: unlock question, unfreeze subject, recode question, refreeze subject, relock question.

   
   The number of locked and frozen responses is shown on the screen and the lock/freeze status of each response is included in the .csv file that can be exported after searching for matching responses.

   
   All unfreeze/freeze and unlock/lock actions that occur as part of the recoding process are recorded in the lock/freeze history, in the order that they occur.
   

    

5. Work through each of the following three sections to find the terms that are different in the new dictionary.
   

In each section, you have the option of exporting the list of responses found to a .csv file. Responses are listed in site/subject order.

If you want to change the location of these files, click Change File Path and select a new one. The log files containing details of processed files are also saved here.

You can change the separator used in the .csv files. How to do this

To access the Recode Responses option as described above, you need both the 'Auto encode' and 'Change clinical status' permissions

LLT with Primary and Current:

1. Click Select Responses.

2. In the 'Responses found' field you will see the total number of responses using a Low Level Term that is still marked as Primary and Current in the new dictionary. The two following fields show the number of matched responses that are currently locked, and the number of matched responses that are currently frozen.

3. To export the list for reference, click Export List to File. This file is named 'Study Name_LPCYes_Response_Details_timestamp.csv'

4. To recode the responses against the new dictionary, click Recode.

Details of the processed responses can be viewed in the log file named 'Study Name_AutoCodedStatus_timestamp.csv'. Details include the new status for each successfully processed response and an explanatory error message for any response that could not be changed.

To recode responses as described above, you need the 'Auto encode' permission

LLT with Non Primary/ Non Current:

1. Click Select Responses.

2. In the 'Responses found' field you will see the number of responses using a Low Level Term that is still present in the new dictionary but no longer marked as Primary and Current. The two following fields show the number of matched responses that are currently locked, and the number of matched responses that are currently frozen.

3. To export the list for reference, click Export List to File. This file is named 'Study Name_LPCNo_Response_Details_yyyyMMddHHmmss.csv '

4. To change the clinical coding status of these responses to Not Coded, click Set to Not Coded. You will need to manually code these questions again.

Details of the processed responses can be viewed in the log file named 'Study Name_SetNotCoded_timestamp.csv'. Details include the new status for each successfully processed response and an explanatory error message for any response that could not be changed.

To change the clinical coding status as described above, you need the 'Change clinical status' permission

Responses with Not Matched Terms:

1. Click Select Responses.

2. In the 'Responses found' field you will see the number of responses using a Low Level Term that is no longer present in the new dictionary. All appropriate responses are returned here, including locked and frozen questions. The lock/freeze status is ignored in this section but is included in the exported list.

3. To export the list for reference, click Export List to File. This file is named Study Name_UnMatchedTerms_Response_Details_yyyyMMddHHmmss.csv

Be aware that because these terms are unmatched, the information in the Primary and Current columns is taken from the older version of the dictionary that was used for the original coding, and not from the new version.

Related Topics

Registering a medical dictionary