Clinical Operations.png
Clinical Operations.png

Clinical Operations Procedures

$500.00

This package includes a Clinical Operations SOP and accompanying templates for the required processes and documentation for clinical investigation of a medical device in human subjects.

This package includes a Clinical Operations SOP and accompanying templates for the required processes and documentation for clinical investigation of a medical device in human subjects.

This documentation package includes standard templates and forms to support clinical investigations:

  • Clinical Operations Standard Operating Procedure

  • Clinical Adverse Events Management Standard Operation Procedure

  • Clinical Trial Agreement

  • Financial Disclosure Form

  • Clinical Training Record Form

  • Site Training Log

  • Signature and Delegation of Authority Log

  • Subject Enrollment Log

  • Device Accountability Log

  • CRF Transmittal Form

  • Data Clarification Form

  • Site Qualification Assessment Form

  • Site Initiation Visit Report Form

  • Site Interim Monitoring Visit Report Form

  • Site Closeout Visit Report Form

  • Site Visit Log