Upversioning to a New Dictionary Release

When a new MedDRA, MedDRAJ, WHODrug, or JDrug dictionary release is available, you can upversion a single Form or Synonym List, upversion multiple Forms at once, or upversion a Synonym List and all Forms that are bound to it.

Vault Coder makes new dictionary releases available within 30 days after they are publicly available.

What Happens During Upversioning

When you upversion a Form or Synonym List, the system evaluates the full assigned code of every Code Request (for Forms) or Synonym (for Synonym Lists) to determine if it exists in the new dictionary release. If the full assigned code does not exist in the new dictionary release, then the system will attempt to remap the code. If it can remap the code, then the code is updated and the Coding Status remains Coded or Autocoded. If the system cannot remap the code, then the code is cleared and the Coding Status is set to Noncurrent. If the Autocode from Dictionary study setting is set to Yes, then the system will attempt to use the new dictionary to autocode all the Code Requests that are not yet coded.

Upversioning a Form

When you upversion a Form, the system evaluates the full assigned code of every Code Request to see if it exists in the new dictionary release. If a full assigned code does exist in the new dictionary release, then the system does not alter it. If a full assigned code does not exist in the new dictionary release, then the system performs different steps depending on whether Code with ATCs is enabled in the study settings.

For MedDRA and MedDRAJ upversioning, and for WHODrug and JDrug upversioning in studies that do not have Code with ATCs enabled in the study settings, the system does the following:

  1. Attempts to remap the verbatim by evaluating the assigned LLT Codes (for MedDRA and MedDRAJ) or Drug Codes (for WHODrug and JDrug) to see if they exist in the new release. In the case of MedDRA and MedDRAJ the system only remaps to Primary Path.

  2. If an assigned LLT Code or Drug Code does not exist in the new dictionary release, the system tries to remap by locating matches with the assigned LLT Label, assigned Drug Name (for WHODrug), or assigned Basic Drug Name (for JDrug). In the case of MedDRA and MedDRAJ the system only remaps to Primary Path.

  3. If the system locates a match, it remaps the matching code to the verbatim.

  4. If the system cannot locate a match, it clears the current status of the Code Request and sets the Coding Status to Noncurrent.

  5. If the Autocode from Dictionary study setting is set to Yes, then the system will attempt to autocode any uncoded Code Requests using the new Dictionary.

For WHODrug and JDrug upversioning in studies that have Code with ATCs enabled in the study settings, the system does the following:

  1. Attempts to remap the verbatim by evaluating the assigned WHODrug or JDrug Code.

  2. If one match is found, the system remaps to the matching Drug Code.

  3. If multiple matches are found, the system checks the highest assigned ATC Code and highest assigned ATC Label, performing remapping if a match is found.

  4. If no match is found, the system tries to remap by locating matches with the assigned Drug Name (for WHODrug) or the assigned Basic Drug Name (for JDrug).

  5. If one match is found, the system remaps to the matching Drug Name or Basic Drug Name.

  6. If multiple matches are found, the system checks the highest assigned ATC Code and the highest assigned ATC Label.

  7. If the system locates a match, it remaps the matching code to the verbatim.

  8. If the system cannot locate a match or if it locates multiple ATC matches, it clears the current status of the Code Request and sets the Coding Status to Noncurrent.

If the Autocode from Dictionary study setting is set to Yes, then the system will attempt to autocode any uncoded Code Requests using the new Dictionary. Once you upversion the Form, Vault Coder begins to draw dictionary search results from the new dictionary release.

Upversioning a Synonym List

When you upversion a Synonym List, the system checks whether the full assigned code for each Synonym within the Synonym List can be found in the new dictionary release. If the full assigned code cannot be found in the target dictionary release, then the system performs different steps depending on whether the Code with ATCs study setting is enabled.

For MedDRA and MedDRAJ upversioning, and for WHODrug and JDrug upversioning in studies that do not have Code with ATCs enabled in the study settings, the system does the following:

  1. Attempts to remap the Synonym by evaluating the assigned LLT Codes (for MedDRA and MedDRAJ) or Drug Codes (for WHODrug and JDrug) to see if they exist in the new release. In the case of MedDRA and MedDRAJ the system only remaps to Primary Path.

  2. If an assigned LLT Code or Drug Code does not exist in the new dictionary release, the system tries to remap by locating matches with the assigned LLT Label, assigned Drug Name (for WHODrug), or assigned Basic Drug Name (for JDrug). In the case of MedDRA and MedDRAJ the system only remaps to Primary Path.

  3. If the system locates a match, it remaps the matching code to the Synonym.

  4. If the system cannot locate a match, or if it locates more than one match, it clears the assigned code and sets the Approval status to Noncurrent.

For WHODrug and JDrug upversioning in studies that have Code with ATCs enabled in the study settings, the system does the following:

  1. Attempts to remap the Synonym by evaluating the assigned WHODrug or JDrug Code.

  2. If one match is found, the system remaps to the matching Drug Code.

  3. If multiple matches are found, the system checks the highest assigned ATC Code and highest assigned ATC Label, performing remapping if a match is found.

  4. If no match is found, the system tries to remap by locating matches with the assigned Drug Name (for WHODrug) or the assigned Basic Drug Name (for JDrug).

  5. If one match is found, the system remaps to the matching Drug Name or Basic Drug Name.

  6. If multiple matches are found, the system checks the highest assigned ATC Code and the highest assigned ATC Label.

  7. If the system locates a match, it remaps the matching code to the Synonym.

  8. If the system cannot locate a match or if it locates multiple ATC matches, it clears the current status of the Code Request and sets the Approval Status of the Synonym to Noncurrent.

Vault Coder locks the Study while upversioning is in progress. Users can’t perform any coding activities until upversioning is complete.

Before upversioning, you can generate an Impact Report to preview the impact of upversioning on your Study and Form.

If upversioning fails, the affected Form or Synonym List will show a status of Failed Upversioning. You can continue to code a Form that has failed upversioning until a Coder Administrator restarts the upversioning process.

Restrictions on Upversioning

The following restrictions control which dictionary releases you can upversion to:

  • You can only select a version of the dictionary higher than the release that is currently assigned.
  • Upversioning is only allowed within the same dictionary type. For example, if the currently assigned dictionary is WHODrug, B3 format, you cannot upversion to WHODrug C3, or MedDRA.

Upversioning Impact Report

You can preview the impact that upversioning will have before initiating upversioning. This generates an Excel™ file that details the changes that will be made to Code Requests that are already coded. If you preview the impact for both a Synonym List and one or more Forms, the impact report includes two files, one for the Synonym List and another for the Forms.

To generate the impact report, select the Synonym List and Forms that you want to upversion and click Preview Impact. When finished, Vault sends you an email notification with a link to download the report.

Preview Impact

Batch Upversion a Synonym List & Assigned Forms

To upversion a Synonym List and the Forms bound to it:

  1. Navigate to Tools > Coder Tools > Upversioning.
  2. Select a Synonym List. To upversion a Synonym List and its assigned Forms, select the options Synonym List and Forms.
  3. Optional: Filter the list of Forms available for upversioning by selecting a Source Dictionary. Then, Vault only lists Forms that are assigned to that source dictionary version.
  4. Select a Target Dictionary.
  5. Select the Forms you want to upversion. You can use the search and filter options to locate the Forms you need.
  6. Optional: Select the Select All Forms checkbox to select all Forms for upversioning.
  7. Optional: Click Preview Impact to generate an upversioning impact report. Vault generates the report and sends you an email notification with a link to download the report (Excel™).
  8. Optional: If you have not selected to upversion all the Forms the selected Synonym List is assigned to, choose what to do with the unselected Forms in the Forms Not Upversioning dialog and click Next.
  9. Click Upversion. The Upversioning job is queued, and Vault send you an email notification when it is complete,

Upversion the Dictionary for a Form

To upversion a single Form to a newer dictionary version:

  1. Navigate to Tools > Coder Tools > Upversioning.
  2. Click Forms and choose a Source Dictionary and Target Dictionary.
  3. Click the checkbox next to the Study or Studies that you want to upversion.
  4. Optional: Click Preview Impact to generate an upversioning impact report. Vault generates the report and sends you an email notification with a link to download the report (Excel™).
  5. Click Upversion. Vault begins the upversioning process. This may take a few minutes. When finished, Vault sends you an email notification.

Once upversioning is finished, you can assign a Synonym List from the new version to your Form.

Upversion the Dictionary for a Synonym List

To upversion a Synonym List to a newer dictionary release:

  1. Locate the Synonym List you want to edit in Coder Tools > Synonym Lists.
  2. Hover over the Synonym List to display the Actions menu.

  3. From the Actions menu, select Upversion. Upversion Synonym List

  4. In the Upversion dialog, select a new Dictionary Release. Select Dictionary

  5. Click Run Now. Vault begins a job to upversion the Synonym List. When finished, Vault sends you an email notification which includes the impact report.

Optional: Rename the Synonym List

As a best practice, Veeva recommends that you rename your Synonym List to include the name of its new dictionary release.

To rename the Synonym List:

  1. Locate the Synonym List you want to rename Coder Tools > Synonym Lists.
  2. Hover over the Synonym List to display the Actions menu.

  3. From the Actions menu, select Edit. Vault opens the Edit Synonym List dialog. Edit action

  4. Enter the new Name for your Synonym List. Edit Synonym List dialog

  5. Click Confirm.

Reassign the Upversioned Synonym List to a Form

Because the Synonym List for a Form is Unassigned when the form is given a new dictionary release, you must manually reassign the Synonym List to the Form from Coder Tools > Study Settings.

  1. Navigate to Coder Tools > Study Settings.
  2. In the Form Configuration section, locate the Form that you upversioned.

  3. From the form’s Actions menu, select Edit. Assign Synonym List to Form

  4. In the Edit dialog, select a Synonym List to assign to the Form. Select Synonym List

  5. Click Save.