13.3 Code in Study Runner

Once coding tables have been configured in Study Designer and published, authorized users can begin coding verbatim entries through the Study Runner interface.

Users with Coder or Reviewer permissions will see a Coding Tables section in the Tasks menu.

• The coding tables listed in this section will match the titles (Table Display Name) defined during study design.
• Clicking on a table name opens the live coding interface for that specific verbatim source.

Understanding the Coding Table Layout

The OpenClinica Code module screen provides a two-pane interface for reviewing coded results and assigning standardized MedDRA codes.

• The top section lists all entered Verbatims for review and filtering.
• The bottom section allows the user to search MedDRA and apply codes to the selected event.

Top Section – Verbatims

The top section is designed to manage and review all reported records. It allows you to see which events have been entered, check their coding status, and select events for coding.

Each row corresponds to one record and includes the following columns:

• Verbatim: The free-text term entered by the site user (e.g., “Extreme fatigue”). This acts as a link to open the form in Review mode focused on the item when clicked.
• Status: Indicates the current stage of coding:
  • Verbatim Entered: A verbatim term has been entered but has not yet undergone any coding attempt. Typically verbatims will be checked by the autocoding feature and transitioned to the appropriate next step (see below) very quickly.
  • Needs Code: The system attempted to auto-code the verbatim, but no matching MedDRA term was found. Manual coding is required.
  • Needs Review – Autocoded: The system successfully applied an automatic code to the verbatim during the autocoding process, but the code has not yet been reviewed or confirmed by a user.
  • Needs Review – Manually Coded: A user has manually assigned a MedDRA code to the verbatim, but it has not yet been reviewed or approved. Verbatims in this status are excluded from future autocoding attempts.
  • Approved: A user with the appropriate coding review privileges has reviewed and confirmed the assigned code—whether applied manually or through autocoding. No further action is required.
• Code (LLT): Displays the Lowest Level Term (LLT) code once a term is coded. Mouse over this column to see the full MedDRA hierarchy coded.
• Context Columns: Configured in Study Designer, provides extra data to the coders about the verbatim being coded.
• Participant: Shows the participant ID for traceability. This acts as a link to the Participant Details Page.

A checkbox at the left of each row allows the user to select one or more verbatims for coding or management. A magnifying glass next to the checkbox allows the user to search MedDRA for that row’s verbatim.

A query icon appears next to the verbatim name. Click the icon to view queries in the form record. If your role includes permission to update or close queries, you can perform those actions as well.

Above the table are action buttons (e.g., Approve, Reject, Clear, Add Query) and a drop-down (e.g., Active Records) to manage coding decisions and filter which records are displayed.

Each column header includes a sort arrow and a filter icon. The user can click these to sort entries or filter the list by that column’s values/data.

Bottom Section – MedDRA Term Search and Selection

The bottom section is designed to search for and apply the appropriate code to the selected verbatim(s). By entering a search in the bottom panel, you retrieve all matching MedDRA LLTs and can choose the most precise term. This ensures that the selected verbatim(s) is/are coded using standardized MedDRA terminology.

Key Features

• Search Field: At the top of this section is a text box labeled Search. You can type a keyword or phrase into this field and click Search (or press Enter). The system will then display matching MedDRA terms.
• Show only Primary SOC: A checkbox option allows you to restrict results to terms whose System Organ Class (SOC) is the term’s primary SOC.
• Results Table: Under the search box is a table of MedDRA term options. Each row shows one candidate term with the following columns:
  • LLT (Lowest Level Term): The MedDRA Lowest Level Term and its code. This is the most specific term that can be applied.
  • PT (Preferred Term): The MedDRA Preferred Term that the LLT maps to.
  • HLT (High Level Term), HLGT (High Level Group Term), SOC (System Organ Class): Higher levels of the MedDRA hierarchy for the selected term. These columns provide context so you can see how the term fits in the overall MedDRA structure.
  • Primary: Indicates whether the listed SOC is the term’s primary SOC (Yes or No).
• Apply Code Button: On the left of each results row is an Apply Code button. Clicking Apply Code assigns that LLT to the selected verbatim(s). When a code is applied, the term’s code and LLT text will automatically populate the Code (LLT) column of the top section for the selected verbatim(s). If a code is applied with multiple verbatims selected, the code will be applied to all of them.

Using the MedDRA Coding Screen

Once data is entered into the Adverse Events form, the MedDRA Coding screen is used to assign standardized MedDRA codes. This process may happen automatically (autocoding) or require manual coding. Both workflows are supported through the two-panel interface described above.

Coding Process Overview

1. Autocoding:
   OpenClinica automatically attempts to code entries when the verbatim term exactly matches a MedDRA Lowest Level Term (LLT). Autocoding is run on every new verbatim value as soon as it is entered into the form.
   • If a match is found, the corresponding LLT is automatically assigned.
   • The Code (LLT) column in the top panel is populated with the term and code.
   • The Status updates to Needs Review – Autocoded.
2. Manual Review / Approval After Autocoding
   A reviewer must:
   • Confirm the match is accurate by comparing the LLT with the verbatim term.
   • If the code is appropriate, select the checkbox and click Approve to confirm the assignment.
   • If the code is not appropriate, proceed with manual coding (see below).
   • This review step ensures quality control and allows intervention when the verbatim matches the dictionary term technically but not clinically.
3. Manual Coding:
   When no exact match is found during the autocoding process the user must assign a code manually.
   1. Locate and select the event
      • In the top panel, find the row with status Needs Code or Needs Review – Manually Coded / Autocoded.
      • Click the magnifying glass icon to initiate a search for the verbatim term.
   2. Search for a MedDRA term
      • In the bottom panel, verify the results obtained or if it shows No results found, enter the term from the event description into the Search for LLT field.
      • Click Search to display matching LLTs. The results table will list all possible matches.
      • Use the Show only Primary SOC option to narrow results if needed.
        💡 Notes:
        1. If no results are returned, try using a more general search term (e.g., “knee” instead of “knee trouble”).
        2. If too many results are returned, refine the search by using a more specific term (e.g., “chest pain” instead of “pain”)
   3. Review search results
      • Carefully evaluate each result’s LLT, PT, HLT, HLGT, SOC, and Primary classification.
      • Select the MedDRA term that most accurately reflects the reported event based on your study’s coding standards.
   4. Apply the MedDRA code
      • Select the event row in the top panel if not already selected.
      • The Apply Code button for the desired LLT will become active.
      • Click Apply Code to assign it to the event.
   5. Finalize or edit
      • The Status will update to Needs Review – Manually Coded.
      • If the code is appropriate, select the checkbox and click Approve to confirm the assignment.
      • If incorrect, click Clear to remove the code and re-enter the search process.
      • Use Add Query to raise a data clarification query if the verbatim is unclear or incomplete.

Result Loading Behavior

Search results are loaded dynamically. The first entries appear within a few seconds, but complete results may take 30–45 seconds if many matches exist.

Additional Actions

Use the buttons at the top of the coding interface for the following actions:

Each action applies to one or more selected rows. Use the checkboxes to select the relevant records.