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Preparing Modified Data Structures

for NDA Approval

Latest Update: Oct. 30 2025

The modified data structures within the IMPACT-MH consortium are those that include both existing NDA data elements and new data elements. These data structures must be approved by the NDA prior to data submission.

The name of the data structure will not change. The data elements will change based on your modifications.

IMPORTANT: The DCC (Dr. Kalpana Raja) will submit the request to the NDA on your behalf. You will be notified by the DCC when the request is approved. 

The following are required to submit your request:

  1. A modified “Definitions file” that outlines your requested changes
  2. Number of participants you anticipate recruiting
See flowchart for directions

Step-by-Step Instructions

The following instructions have been adapted from the NDA website.

The DCC requires you to take the following steps for obtaining approval from the NDA:

  1. Locate the Definitions file: Visit the Data Structure’s page from the NDA website and download the “Definitions” file from the Data Structure page that you want to modify (see Fig. 1). This should be a .csv formatted file and can be edited in Excel.

           Or 

          You could use the NDA Mapper tool (https://nda.impact-mh.org/) to search for a data structure.

Fig. 1 "Definitions" File
  1. Download the definitions File: 
    • IMPORTANT: Save the Definitions file as an .XLSX file.
    • The NDA has very specific rules about color coding modifications. There are three colors to use. If there are Data Elements already in the Data Structure you wish to modify:
      • Modify the Data Element row with your requested changes in the Definitions file.
      • Highlight the changes in yellow (e.g., if you want to add a value to the ‘my_raw_score’ Value Range highlight the corresponding ValueRange and Notes column that says ‘Integer’ in yellow).
      • Optional: Add a column to annotate any changes or notes for the NDA Data Curators.
Fig. 2. Modifications to existing Data Elements in the Data Structure’s Definition File.
    • If you wish to add a Data Element to the Data Structure that already exists in the NDA:
      • Add a new row to the Definitions file.
      • In Column A, provide the  Data ElementName.
      • Highlight the Data ElementName in blue (can be any shade of blue).
      • If you need to make any modifications to the Data Element, highlight your changes in yellow.
      • Optional: Add a column to annotate any changes or notes for the NDA Data Curators.
Fig. 3. Adding an Existing Data Element with & without changes to the Data Structure’s Definition File
    • If the Data Element you wish to add is not listed in the NDA, or you need to make changes that are generally not allowed** to create a Data Element, add a new row in red text to the Definitions file and provide the following:
      • Data Element Name (make sure the Data Element Name you propose does not match any existing Data Elements by searching the NDA with your proposed name).
      • Data Type.
      • Size (only for String Data Types).
      • Description.
      • Value Range.
      • Notes (if applicable).
Fig. 4. Adding a New Data Element to a Data Structure's Definition File.
    • Save the file in a spreadsheet format (.xlsx), rather than the .csv format, so that formatting changes are saved!
    • Create a new .txt file to record the number of participants you anticipate recruiting.
    • Send the definitions file (promisgl01.xlsx) and the text file with the number of participants to Dr. Kalpana Raja.

As a reminder, the DCC (Dr. Kalpana Raja) will submit the request to the NDA on your behalf. You will be notified by the DCC when the request is approved. 

Once you are notified of the approval, contact Christian Horgan, and/or Ahmed Abdelhady to proceed with data submission. 

**More details on the authorized modifications and prohibited modifications & suggested actions can be found on the NDA website.

If you have any questions, please contact Dr. Kalpana Raja.