Optimisation of Monitoring for Clinical Research Studies

Completed

• Conditions: Healthy
• Interventions: Other: classical monitoring strategy; Other: optimized monitoring strategy

• Registration Number: NCT00780091
• Lead Sponsor: University Hospital, Bordeaux

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 scientific and regulatory principles.

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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-21
• Study First Submitted QC: 2008-10-24
• Study First Posted: 2008-10-27
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-11
• Last Update Posted: 2010-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1800

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

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	classical monitoring strategy	classical monitoring strategy
2	optimized monitoring strategy	optimized monitoring strategy

Primary Outcome Measures

Name	Time	Method
Proportion of patients' file without severe error.	at end of follow-up

Secondary Outcome Measures

Name	Time	Method
Compounds of the main outcome, other errors, delay to get the results, costs	at end of follow-up

Trial Locations

Locations (1)

Unité de Soutien Méthodologique à la Recherche Clinique et Epidémiologique du CHU de Bordeaux; 🇫🇷 Bordeaux, France