Study execution and conduct

The main Study Start-Up activities:

• Perform high-quality feasibility
• Identify and qualify sites and investigators
• Prepare documentation for IRB and/or Ethics Committee approval
• Initiate or assist in budget negotiations with the sites

Main Study Execution activities:

• Track overall study progress and progress of individual sites
• Deliver customized reports (“Dashboard”) with critical study metrics including deviations, enrollment rates, and adverse events with trend analyses
• Develop a randomisation scheme and either paper or web-based subject randomisation system
• Represent the sponsor with regulatory agencies if required

Project management

Lead Project Manager:
The ESAIC will assign a Lead Project Manager who will be the primary point of contact. The Lead Project Manager will provide regular and detailed updates of the study status and progress.
In case the sponsor proposes a study protocol, ESAIC will perform a review of the protocol methodology and implement the findings accordingly.

Kick-off Meeting:
The ESAIC project manager, in collaboration with Chief Investigator and sponsor, will organize a project team Kick-off Meeting to explain the approach, key milestones, and deliverables for the project.

Investigators:

If required, the ESAIC network of investigators will assign a Chief Investigator and National Coordinator for each country.

These investigators are  experienced researchers. They are available to assist in coordinating for screening potential patients, providing expert training to other study staff, etc.

The Chief Investigator will be directly involved in:

• Protocol design
• Site selection and contracting
• Recruitment follow-up and monitoring
• Data safety monitoring board organisation
• Steering committee coordination

Data Management: Data Quality and Validation

The ESAIC Data management team can carry out all data management tasks including database and eCRF design, medical coding and provide all associated processes, documents and training.