CRO Products and Services
Quality Assurance
Investigative Sites Audit
- We 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
- We verify that the data collected in a representative sample
of
Case Report Forms (CRF-s) 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 clinical
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, CRF-s,
and database. - Ensure internal consistency in reports
- Preparation for regulatory inspection
Covering:
o Trial master file audits o System audits o Site audits
o Central laboratory audits o Data base audits o Final clinical report audits