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Post Study Data Archiving for Sites and Sponsor

Learn how to export data for archiving purposes, both for sponsors and sites.

There are several ways for the site to have access to their data after study completion.

1) The site data can be exported, either as a .CSV or the eCRFs can be saved as pdfs to either a CD or a USB drive, that can be handed to the site. This way they have a 'physical' copy of the data they can archive with any physical study documentation they might have. They should of course remember to keep this in a locked cabinet or something similar.

2) Site data can be stored in SMART-TRIAL, as we offer free archiving with enterprise agreements, for as long as you want. We do not delete any databases, only the study owner can delete the study.

Your sites can then access the study anytime they want, using their existing SMART-TRIAL accounts. This of course has the drawback, that the study owner will have to manage access routinely, to ensure only authorized users have access, in case anyone at the sites quits or new team members join.

3) The last option is to print all the eCRFs and store them at the site. The is also a bit of work, as each enrolment has to be printed individually, so if you have a lot of enrolments it might take a while.

You can save an entire patient enrolment at once.

Please note: we recommend that you use the Chrome browser to print as PDF as this has provided the best experience to date.

To create a PDF/print the enrolments:

  1. Go to the subject profile, click "Record History" in the overview.
  2. Click the printer icon. It might take a little while to load, depending on how many forms you have.

    Post Study Data Archiving for Sites and Sponsor 1

  3. Choose "Save as pdf" and click "save" to save the enrolment file as a PDF, otherwise choose your printer and press "print. 

    Post Study Data Archiving for Sites and Sponsor 2