Skip to main content

Clinical Development Resources

Browse our clinical development resources to find the latest articles, blogs, brochures, and videos from our experts. See the latest content below.

Management and Archiving Study File SOP Considerations

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.