The site will prepare and maintain all study records on site. All records will be maintained in a secure area accessible only to the site staff during and after the trial. Relevant records will include:
- All patient medical records and source documentation
- Investigator Site File
- Site staff training
- Financial records
- Case Report Forms (CRFs), if electronic a sponsor provided CD is sufficient
- All records will be archived in a secure location on-site or off-site to meet sponsor and local regulatory requirements.