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Populating your Data Expected List

How to populate the Data Expected List is one of the most common questions NDA gets.

The Data Expected List is a list of your data collection entities. Each entry in the Data Expected List must correspond to one or more NDA Data Structures. You must provide information about how many subjects will have data collected against each item in the list (Targeted Enrollment), as well as information about initial submission and share dates.

Key TakeawaysData Expected List OverviewData Expected List DefinitionsData Expected List ComponentsMandatory Data StructuresInformation IconData Structures per Research AimsTargeted EnrollmentInitial Submission DateSubjects SubmittedInitial Share DateSubjects SharedStatus & ActionsData StructuresData ElementsFinding Data Structures to Add to Your Data Expected ListSearching Tools for Finding Data StructuresSearching for your Data Structures in NDAAdding Data Structures to your Data Expected ListAdding Existing Structures from NDA Data DictionaryRequest Changes to Data StructuresCreating New Data Structures

Creating New Data Structures

Last Modified on June 28, 2023

If you are collecting data using a data collection entity that is not defined in the NDA Data Dictionary, you can request to create a new Data Structure. Requests for new Data Structures are reviewed by a Data Curator after uploading the zipped file to your Data Expected List.

  • NOTE: If you find a Data Structure in the NDA Data Dictionary that is a close match (at least half of your requested Data Elements are in the Data Structure), please request changes to the existing Structure rather than creating a new Data Structure.

To create a new Data Structure:

You must first have a zipped file that includes the following documents:

New Data Structure Template

The New Data Structure Template defines the original assessment in the format consistent with NDA formatting standards.

  1. Download the New Data Structure Template and save the file in .xlxs or Excel format.
  2. Follow the instructions and rules outlined in the ReadMe tab to make any of the following requests:
    1. Add an existing Data Element from the NDA Data Dictionary to your Data Structure.
    2. Add an existing Element from the NDA Data Dictionary with modifications to your new Data Structure.
    3. Request to create a new Data Element (that does not already exist in the NDA Data Dictionary).
ReadMe Tab in New Data Structure Template
Figure 46 - ReadMe Tab in New Data Structure Template. Click the image to enlarge the picture.
  1. Edit the Structure Template tab with your requests.
Structure Template tab in New Data Structure Template
Figure 47 - Structure Template tab in New Data Structure Template. Click the image to enlarge the picture.
  1. Zip the Categories and Description Template (.xlsx format), the New Data Structure Template (.xlsx format), and the original assessment (.pdf or .docx) into one file.

Category & Description Template

The Category & Description Template provides additional metadata information required for Data Curators to create a new Data Structure in the NDA Data Dictionary.

  1. Download the Category and Description Template and save the file in .xlxs or Excel format.
  2. Add your new Structure's Title in Column A.
Column A, Structure Title
Figure 48 - Column A, Structure Title. Click the image to enlarge the picture.
  1. Provide a description outlining the purpose of the Data Structure in Column D. Include any relevant DOIs if applicable.
Column D, Description
Figure 49 - Column D, Description. Click the image to enlarge the picture.
  1. Optional: Provide any Reference links, notes, etc., to provide additional context to your Data Structure for the NDA Data Curators to review.
Column E, Reference
Figure 50 - Column E, Reference. Click the image to enlarge the picture.
  1. In the Categories tab, select one or more Categories that best describe the subjects being accessed in your Data Structure.
Categories Tab
Figure 51 - Categories Tab. Click the image to enlarge the picture.
  1. List the Categories in Column C in the Category and Description Template tab.
Column C, Category
Figure 52 - Column C, Category. Click the image to enlarge the picture.
  1. Save the file in the .xlsx format.
  2. Zip the Categories and Description Template (.xlsx format), the New Data Structure Template (.xlsx format), and the original assessment (.pdf or .docx) into one file.

Once your new zipped file contains the three documents:

  1. Visit your Data Expected tab in your NDA Collection.
  2. Click on the New Data Expected button.
New Data Expected button
Figure 53 - New Data Expected button. Click the image to enlarge the picture.
  1. Select the Request New Data Structure radio button.
Upload Definition Radio Button
Figure 54 - Upload Definition Radio Button. Click the image to enlarge the picture.
  1. Enter the Targeted Enrollment, Initial Submission and Initial Share Dates, and the Title of your Data Structure. When creating a Title:
    1. Use a descriptive full title with proper capitalization.
    2. Do not use abbreviations.
    3. It must not duplicate another Data Structure’s title.
    4. The title is not editable afterward.
    5. If a mistake is made, the process to create a new Data Structure will start from the beginning.
Upload Definition Fields
Figure 55 - Upload Definition Fields. Click the image to enlarge the picture.
  1. Click Select File and choose your zipped file containing:
    1. The original source material (e.g., PDF or .docx).
    2. New Data Structure Template (.xlsx format).
    3. DOI Information or Category & Description Template (.xlsx format).
Select File Button & File Explorer
Figure 56 - Select File Button & File Explorer. Click the image to enlarge the picture.
  1. Click on the Add Data Expected button
Add New Data Expected button
Figure 57 - Add New Data Expected button. Click the image to enlarge the picture.
  1. The new Data Structure and your uploaded file will appear in your Data Expected list, with the "Status Requested New".
New Requested Data Structure Listing and File
Figure 58 - New Requested Data Structure Listing and File. Click the image to enlarge the picture.
  1. Your request will be reviewed by an NDA Data Curator . Please wait until a Data Curator reaches out regarding your request before submitting any data to the Data Structure.
  2. When the Data Structure is created and approved by NDA, its name and Short Name will appear when you press "i" icon. You can then download the submission template for your new Data Structure and start submitting data.