Augment data collection processes with data extracts

Data managers can now extract subject data from a study. The Subject Data Extract (Unblinded) contains all form data collected for subjects during a study.

What are the benefits?

With this new feature, you now have the ability to extract clinical data stored in the Oracle Clinical One Platform repository in a different format that is useful for data analysis or regulatory reporting. In turn, this further enhances the data collection processes in the study you work in, improving the quality of data and the efficacy of the study. For this data extract, we've adopted the Study Data Tabulation Model (SDTM), part of the Clinical Data Interchange Standards Consortium (CDISC) to make sure we're following the industry's top standards in terms of code lists and data sets.

In a future release, data extracts will also include SAS properties, so work with your study designer to make sure those fields are specified correctly within the study. For more details on SAS properties, see Add SAS properties to improve data analysis.

Besides all form data that will be included in a data extract, note that data extracts will also contain codes configured in code lists.

Details for user administrators

Your workflow hasn't changed. However, there is a new permission that you need to be aware of.

If the user that is extracting data already has a role that includes the appropriate permissions, no action is required. The user will be able to start working immediately after the system update.

The following new permission allows data managers and statisticians to extract data:

Table 18-3 New permission for extracting data

New permission	Tasks that users with this permission can perform	Existing role that should get this permission assigned to them
Run the Subject Data Extract Unblinded report	Extract both blinded and unblinded subject data from your study	Data manager

Details for data managers

Here's what's new in your workflow if you're assigned the task of performing data extracts:

• On the Reports tab, with the appropriate roles and permissions, you can extract blinded and unblinded subject data using the new Subject Data Extract (Unblinded)
• The Subject Data Extract (Unblinded) is a ZIP archive containing a CSV file per each form created in a study. Subject data can be extracted for either a selection of sites or all sites, depending on how you configure the extract's settings

More details on what exactly you'll see in a data extract will be coming soon.

Figure 18-30 How data managers can extract data in the system

Already working in a live study?

As soon as the upgrade for this release is complete, with the appropriate role and permissions, you can start extracting subject data in Testing, Training, or Production mode.