|
| |
Clirophtha's project leaders are the managers of the study and also the sponsor's principal contact person. They remain responsible throughout the evaluation phase and supervise the planned schedule up to final report. Our project leaders are experienced staff who are regularly trained in new Good Clinical Practice (GCP), study monitoring guidelines, in local legislations and in ophthalmologic pathologies.
|
| |
Mains interventions of the project leader:
|
|
Study set-up
|
National submissions in all European Countries.
Scientific writing (protocol summary, case report form, informed consent and patient information sheet, patient diary and amendment).
Investigator selection.
Files to investigators, hospital director, hospital pharmacy and trial master file.
Contracts with investigators and hospitals.
Investigators' meetings.
Monitoring guideline: edited before to start the study to homogenize the monitoring. Our Clinical Research Associates (CRA)s are specially trained to each study by the project leader.
|
|
Project management
|
Continuous updates of patient status and check of adverse events and serious adverse events.
Site liaison (newsletter…).
Regular monitoring meetings with our CRAs to discuss study progress, general problems occurring and their solutions.
Monitoring checking (reports and reaction to reported problems / questions, adherence of frequency to study visit schedule, recruitment speed and on-site problems).
Study logistics such as sample transport, drug and material supplies.
Investigator's fee management.
Hospital contracts.
|
|
Contacts with the sponsor
|
For each trial, a specific project leader and a supply person are named.
The project leader sends regularly to the sponsor the patient status, site visit report and other documents as required and plans meetings when necessary. He is the point person for clinical, scientific and budget aspects of the clinical trial.
|
|
