Monitoring: The clinical trial follow-up
To monitor means of course to ensure the follow-up of the study :
- Setting-up of investigational centres: meet and inform the contributors, check the means and motivation of the investigators, constitute the administrative file,
- Follow-up visits: detection of difficulties and issues…, confrontation of CRF data with the patients’ files, accountability of treatment units, checking and correction of data,
- Closure visits: checking of the last CRFs, collection of the study material and remaining treatment units, resolution of all residual issues.
But it is also :
- The centralized randomization by fax, phone or the Internet®,
- The data entry and control in continuous flow,
- The coordination of the restocking with study material and study treatment,
- The collection and accountability of residual treatment units,
- The management of adverse events (detection, documentation, validation),
- The management of investigators’ fees and expenses,
- The forwarding of complete and regular study reporting based on real time data management,
- Regular contacts with you so that to ensure co-ordination and optimization.
But above all it is :
- A dedicated Project Manager and his /her team in permanent contact with the study investigators.