Table 6. Types of clinical trial audits.

This table has been created by the authors.

CRF: case report form; CSR: clinical study report; IC: informed consent; PV: pharmacovigilance; SAE: serious adverse event

Product-specific audits program	Pharmacovigilance audits program
Protocol, CRF, IC, CSR
Supplier	Safety data management
Clinical database
Investigator site	Communications and regulatory reporting
Clinical site visit
Study management	Signal detection and evaluation
SAE reporting
Supplier audits program	Risk management and PV planning
Supplier qualification
Sponsor data audit during the trial	Computerized system
Preferred vendor list after the trials
Process/System audits program	Suppliers
Clinical safety reporting
Data management	Regulatory inspection management program
Clinical supply
Study monitoring	Assist with the audit response
Computerized system	Pre-inspection audit