Clinical Investigator Site Audits

We can conduct clinical investigator site audits for the following:

  • Phase I-IV (Drug and Biologics) audits
  • Premarket Approvals (PMA)
  • Routine and “for cause” audits

Benefits:

• Audits conducted while a study is in-process can identify issues that may be may not have been identified during monitoring. Issues identified early can often be corrected without jeopardizing the study.
• Noncompliant clinical investigators can often be brought back into compliance after determining the root cause of issues.
• Provide assurance that clinical trials are conducted in a manner which safeguards research subjects, regulations were followed and quality data exists to support that an investigational product is safe and effective for the marketplace.

Common Discoveries:

After the regulatory submission was made, several high-enrolling sites were selected for audit in anticipation for a FDA inspection. During the audit it was discovered that the site had lost one out of the six boxes of study records. Although the records were not found, copies of the sponsor’s records were forwarded to the site. Notes to File were written to explain the situation and corrective actions were put into effect.
• One site had participated in three similar studies with the same sponsor. During the third study it was identified that the site had neglected to keep original study data for one of the primary endpoints. This was immediately corrected before enrollment ended for this study.