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Optimisation of Monitoring for Clinical Research Studies

NCT00780091 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1800

Last updated 2010-08-12

No results posted yet for this study

Summary

OPTIMON will compare the efficacy and the cost of two monitoring strategies: one based on the classic standards of quality assurance, and the other one being a priori "optimized" on the main scientific and regulatory principles.

Conditions

  • Healthy

Interventions

OTHER

classical monitoring strategy

intensive on-site monitoring, consistently with the pharmaceutical industry practices

OTHER

optimized monitoring strategy

optimized on-site monitoring, depending on patient's risk

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Geneviève CHENE, MD, PhD · University Hospital, Bordeaux

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00780091 on ClinicalTrials.gov