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
Training Opportunities
As training opportunities arise, they will be listed here.
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