Auditing and Monitoring
Monitoring is the act of overseeing the progress of a clinical trial, auditing is a systematic and independent examination of the trial related activities and documents.
Monitoring Services:
- Investigator-Initiated Clinical Trials
- Assistance with developing Monitoring Plan
- Tailored to protocol and risk base assessment
- Full or Brief monitoring plan
- Oversee the progress of a clinical trial
- Source document verification
- Ensure the study is conducted, reported in accordance with:
- Protocol
- SOP’s
- GCP
- All applicable regulatory requirements
- Site visit and/or Remote monitoring
- Pre-study qualification visit
- Initiation visit
- Interim monitoring visits
- Close-out visits
Auditing Services:
- Investigator-Initiated Clinical Trials
- Clinical Registries
- Assistance with developing Auditing Plan
- Optional full or brief audit
Contact Information
If you want more information about our auditing and monitoring services, please contact: christine.robins@curtin.edu.au
Copyright © CCRE. All Rights Reserved
Centre for Clinical Research and Education
Address: School of Population Health, Curtin University, Bentley WA 6102