Creating a dataset

Create a dataset in a site/study

Step 1: Extract Data>Create Dataset: an instructions page will appear

Step 2: Click on "Proceed To Create A Dataset". The system will direct user to a "Select Items" dialogue to choose criteria for dataset (visit then CRFs)

  • User can choose items in each CRFs of each visit
  • User can choose characteristic of visit such as: 
  • User can choose characteristic of study subject such as:
  • User can choose characteristic of CRF such as:
  • User can chose group in a Study/Site
  • User can choose all items and characteristics in Study/Site
  • Note: after selecting, user needs to click "Save and Add More Items" to add other items

Step 3: User click on "Save and Define Scope": the system directs the user to a dialogue to set the scope of the dataset

Step 4: User clicks on "Continue": the system directs the user to a dialogue to configure the dataset:

  • Name
  • Description
  • Item status
    • Item taken from Completed CRFs
    • Item taken from Uncompleted CRFs
    • Item from all Available CRFs

If user wants to generate dataset according to ODM standards then user can keep all the default values as in the above picture. 


Step 5: User clicks on "Continue", the system redirects user to a screen to download data:

  • User can select different formats for their data:
    • CDISC ODM XML 1.3 Full with MedProve extensions : Includes Adudit trail and Discrepancy Notes and MedProve's extensions (like Subject information: status,.., Subject group class)
    • CDISC ODM XML 1.3 Clinical Data with MedProve extensions: Does not include Adudit trail and Discrepancy Notes; Includes MedProve's extensions (like Subject information: status,.., Subject group class)
    • CDISC ODM XML 1.3 Clinical Data
    • CDISC ODM XML 1.2 Clinical Data with MedProve extensions
    • CDISC ODM XML 1.2 Clinical Data
    • View as HTML
    • Excel Spreadsheet
    • Tab-delimited Text 
    • SPSS data and syntax 
    • SAS Data and Syntax

Step 6: User clicks on "Run Now" in the Actions column on the right → The system automatically directs you to the following screen:

If you want to view the exported dataset right below the selected dataset then click on "Back to Dataset" to view all exported datasets.

If you want to view the exported dataset in "View all Datasetes" then click on "Back to View all Datasets" to view all exported datasets.