Prepare for an Audit
An audit is a systematic and independent examination of trial-related activities and documents to evaluate whether the trial-related activities were conducted and the data were recorded, analyzed and accurately reported according to the protocol, Sponsor’s SOP, GCP and other applicable regulatory requirements. Auditors collect evidence and compare against standards, review documents, assess deviations and non-compliance and recommend actions.
Contact the Office for Research Protections Quality Assurance Program for assistance: orp-qm@psu.edu.
Additional Resources:
The Penn State Health (PSH) Clinical Trial Monitoring services are now available for researchers outside of the College of Medicine and Penn State Health system. PHS Clinical Trial monitoring services are fee based and include:
- Creation of a customized data monitoring plan
- Source document verification
- Review of regulatory documents
- Tracking of investigational products
- Data monitoring visits
A description of the DPHS Clinical Trial Monitoring Services available to Penn State investigators is included in the DPHS Data Management Services website at https://med.psu.edu/phs/services