CCRB provides Auditing service on behalf of sponsors. The purpose of an auditing is to perform systemic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the ‘clinical’ data were recorded, analyzed and accurately reported according to the protocol, sponsor’s SOPs, GCP and the applicable regulatory requirements.
The procedure of Auditing includes:

  • Introduce the purpose of auditing
  • Interview with principal investigator and / or study coordinator
  • Inspection of study equipment
  • Verification of study site documentation
  • Verification of study subject documentation
  • Formal auditing report