15.1 Create Datasets

How to Create a Dataset in Site/Study

Step 1: Select Extract Data > Create Dataset: the system displays a guideline.

Step 2: Press on Proceed To Create A Dataset. The system goes to the Select Items screen in which you can select parameters for the dataset.

• You can select Items in each CRF in each Visit
• You can select features of a Visit such as:
  • Visit Location
  • Start Date
  • End Date
  • Visit Status
  • Subject Age At Visit
• You can select features of a Subject such as:
  • Date of Birth
  • Sex
  • Subject Status
  • Secondary ID
• You can select features of a CRF such as :
  • Status
  • Version Name
  • Interviewer Name
  • Interview Data

• You can select group classes in the Study/Site
• You can select all Items in a CRF and features in the Study/Site
• Note: You can click on Save and Add More Items to add more items

Step 3: Click on Save and Define Scope, the system displays a screen to select the time for the dataset.

Step 4: After selecting time, click on Continue, the system displays a screen to enter

• Name of report 
• Description of report
• Item status: 
  • Data from CRFs Marked Complete

  • Data from CRFs not Marked Complete

• Data from all Available CRFs
  
  

Note: If you want to create a dataset with ODM standard, keep all default values in the MetaDataVersion ODM ID and MetaDataVersion Name fields.

Step 5: Click on Continue, the system goes to a screen where you can download data:

• You can select the desired format for your dataset as in the table

• • CDISC ODM XML 1.3 Full with MedProve extensions: includes discrepancy notes, audit trails and extended information such as subject information: status, subject group class,...

• • CDISC ODM XML 1.3 Clinical Data with MedProve extensions: inculdes extended information such as subject information: status, subject group class,.. but DOES NOT include discrepancy notes and audit trails 
  • CDISC ODM XML 1.3 Clinical Data: standard ODM with no extended information and DOES NOT include discrepancy notes and audit trails.
  • CDISC ODM XML 1.2 Clinical Data with MedProve extensions: inculdes extended information such as subject information: status, subject group class,.. but DOES NOT include discrepancy notes and audit trails 
  • CDISC ODM XML 1.2 Clinical Data: standard ODM with no extended information and DOES NOT include discrepancy notes and audit trails.
  • View as HTML
  • Excel Spreadsheet 
  • Tab-delimited Text 
  • SPSS Data and Syntax
  • SAS Data and Syntax

Step 6: If you want to run your dataset, click Run Now in the Actions column → The system navigates to the following screen:

After a few moments, the dataset file is available. To view it, click Back to Dataset.

If you want to view your datasets at View All Datasets, click on Back to View All Datasets.