Update: 10/06/2016
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Investigative sites audit
  • Verify that the protocol is performed according to Good Clinical Practices (GCP) and International Commission on Harmonization (ICH) standards and the sponsor's or CRO's Standard Operating Procedures (SOPs). Review the informed consent content and process.
  • Review records and procedures concerning interactions with the IRB.
  • Review records and procedures concerning drug accountability.
  • Inspect study-required facilities and equipment.
  • Verify that the data collected in a representative sample of Case Report Forms (CRFs) are supported by source documents.
  • Assess compliance with internal SOPs.
  • Study documentation audit 
 

Verify that the protocol is performed according to GCP and ICH standards.
Review records and procedures for site visits. Review study file documentation.
Ensure internal systems used in the conduct of trials are correct, including SOPs for Adverse Experience (AE) reporting, supplies distribution, and data handling.
Assess compliance with internal SOPs.
Compare study report versus the protocol, CRFs, and database. Ensure internal consistency in reports. Preparation for regulatory inspection

Covering:
  • Trial master file audits
  • System audits
  • Site audits
  • Central laboratory audits
  • Data base audits
  • Final clinical report audits
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