Monitoring and Auditing
- Monitoring is the act of overseeing the progress of a clinical trial
- Auditing is a systematic and independent examination of trial related activities and documents
Monitoring Services:
- Investigator-Initiated Clinical Trials
- Assistance with developing Monitoring Plan
- Tailored to protocol and risk-based 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
- Standard Operating Procedures
- Good Clinical Practice
- 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 Quality Registries
- Assistance with developing Auditing Plan
- Optional full or brief audit
Contact information
For further information about our Monitoring and Auditing services, please contact us at CTEP-WA
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Centre for Clinical Research and Education
Address: School of Population Health, Curtin University, Bentley WA 6102