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Optimisation of Monitoring for Clinical Research Studies (OPTIMON)

This study has been completed.
Information provided by:
University Hospital, Bordeaux Identifier:
First received: May 21, 2008
Last updated: August 11, 2010
Last verified: August 2010
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.

Condition Intervention
Healthy Other: classical monitoring strategy Other: optimized monitoring strategy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of Efficacy and Cost of Two Monitoring Strategies for Public Clinical Research - OPTIMON: Optimisation of Monitoring for Clinical Research Studies

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Proportion of patients' file without severe error. [ Time Frame: at end of follow-up ]

Secondary Outcome Measures:
  • Compounds of the main outcome, other errors, delay to get the results, costs [ Time Frame: at end of follow-up ]

Estimated Enrollment: 1800
Study Start Date: May 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
classical monitoring strategy
Other: classical monitoring strategy
intensive on-site monitoring, consistently with the pharmaceutical industry practices
optimized monitoring strategy
Other: optimized monitoring strategy
optimized on-site monitoring, depending on patient's risk

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 industry, and an optimized strategy based on patient's risk level - on their ability to produce exact data, focusing on the main quality criteria: regulatory requirements and scientific validity of results. Optimon is a non inferiority randomized trial.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All type of patients enrolled in the eligible studies

Inclusion Criteria:

  • 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 Criteria:

  Contacts and Locations
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Please refer to this study by its identifier: NCT00780091

Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique du CHU de Bordeaux
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
Study Director: Geneviève CHENE, MD, PhD University Hospital, Bordeaux
  More Information

Responsible Party: Jean-Pierre LEROY / Clinical Research and Innovation Director, University hospital, Bordeaux Identifier: NCT00780091     History of Changes
Other Study ID Numbers: CHUBX 2005/04
Study First Received: May 21, 2008
Last Updated: August 11, 2010

Keywords provided by University Hospital, Bordeaux:
risk scale
non inferiority
cluster randomization
monitoring strategies processed this record on September 21, 2017