What is CTMS data?

CTMS (Clinical Trial Management System) data defines the studies, milestones, sites, subjects, investigators and indications that the eTMF system will manage as components of your Trial Master File.

CTMS data populates many of the options that are available when you work with your eTMF system. For example, when you run the “Create Study” wizard, the choices you see in that wizard come from CTMS data.

The Wingspan eTMF system accepts CTMS data in the form of 7 specfically-named .csv (Comma Separated Value) files.

Do not change the names of these files.

These files are:

• study_details.csv
• site_milestone.csv
• country_milestone.csv
• study_milestone.csv
• subject.csv
• site_investigator.csv
• study_indication.csv
• site.csv

These files can be Uploaded into the eTMF system, or they can be compressed into a single .zip file and uploaded together.

Note: The name of each file must contain the Java name used to specify the file encoding if the file is not encoded as UTF-8.  The encoding is period delimited in the name and comes immediately before the “.csv” extension, (e.g., site_investigators.Cp1252.csv).  The encoding is optional if the file is UTF-8 (e.g., the assumption is the file is encoded in UTF-8).  So study_details.csv will be processed the same as study_details.UTF8.csv.  It should be noted that the default encoding in Windows is typically Cp1252.  A list of common encodings and their Java name can be found here: http://www.devsphere.com/mapping/docs/guide/encodings.html

How To Upload CTMS Data

To Upload CTMS Data, select the More Actions menu in the Top Bar and select Administration. On the Administration page, select the Actions dropdown next to System Configuration and select Upload CTMS Data.

You can upload CTMS Data by selecting ‘Add File(s)’ or by dragging and dropping a file into the window.