Status:
COMPLETED
Optimisation of Monitoring for Clinical Research Studies
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Healthy
Eligibility:
All Genders
Brief 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 scientifi...
Detailed Description
There is no validated standard of monitoring strategy for clinical research studies. Optimon will compare two monitoring strategies - a classical strategy based on the practices of the pharmaceutical ...
Eligibility Criteria
Inclusion
- Clinical Research Studies: risk level A, B, or C in the Optimon risk-assessment scale, with or without a sponsor and the advice of an ethical committee, starting in 2008 and ending before the end of 2010, with a foreseen accrual of 20 patients or more, multicentric with at least 4 clinical sites, with a paper or electronic CRF, with the participating agreement of the coordinating investigator and the sponsor.
- Clinical sites: Sites with a foreseen accrual of 5 patients at least, with the participating agreement of the principal investigator.
- Clinical Research Units: with the label of an institution, with at least 2 years of experience in multicentric studies, with SOPs finalized before 2008, willing to participate in Optimon.
Exclusion
- N/A
Key Trial Info
Start Date :
May 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
1800 Patients enrolled
Trial Details
Trial ID
NCT00780091
Start Date
May 1 2008
End Date
June 1 2010
Last Update
August 12 2010
Active Locations (1)
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1
Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique du CHU de Bordeaux
Bordeaux, France, 33076