mulburg virus phase 2 vaccine clinical trial site readiness assement checklist

1. Site Infrastructure and Resources

Confirm availability of adequate physical space for trial activities.

Assess total square footage required for operations.
Identify distinct areas for patient intake, monitoring, and storage.
Ensure compliance with safety regulations and protocols.
Allocate space for staff and participant interactions.

Ensure necessary equipment is available and functioning (e.g., refrigerators for vaccine storage).

Inventory all required equipment and verify quantities.
Check operational status of refrigerators and freezers.
Schedule regular maintenance and calibration of equipment.
Document equipment functionality tests and results.

Verify access to emergency medical services and facilities.

Identify nearest hospitals and emergency care centers.
Confirm response times with local emergency services.
Establish protocols for emergency situations during trials.
Ensure transport arrangements for participants in emergencies.

Here are some additional steps that could be included in the "Site Infrastructure and Resources" section of the checklist

Assess internet and communication technology capabilities for data transmission and participant communication

Ensure compliance with biohazard safety protocols and availability of personal protective equipment (PPE)

Confirm availability of adequate storage for clinical trial supplies, including vaccines and ancillary materials

Verify that all necessary utilities (electricity, water, HVAC) are functioning and meet trial needs

Evaluate the availability of restrooms and waiting areas for participants and staff

Ensure that the site is accessible for participants with disabilities

Confirm that the site has appropriate waste disposal mechanisms for clinical trial materials

Assess the availability of secure storage for confidential participant records and data

Ensure that signage for the trial site is clear and informative for participants and visitors

Conduct a risk assessment of the site to identify potential hazards related to trial activities

2. Regulatory Compliance

Confirm Institutional Review Board (IRB) approval for the trial.

Obtain a copy of the IRB approval letter.
Verify the approval dates and duration.
Check for any amendments or conditions attached.
Ensure that all study personnel are listed in the approval.

Ensure completion of all necessary regulatory submissions to health authorities.

Compile all required documents for submission.
Confirm submission dates and tracking numbers.
Review feedback from health authorities.
Maintain records of all correspondence and submissions.

Verify compliance with Good Clinical Practice (GCP) guidelines.

Review GCP training records for all staff.
Conduct a self-audit of study protocols.
Ensure proper documentation and data handling.
Address any identified gaps in compliance.

3. Staff Training and Qualifications

Confirm that all site staff have completed required training on the study protocol and GCP.

Ensure staff certifications (e.g., CPR, IATA) are up to date.

Verify roles and responsibilities are clearly defined and understood by all team members.

4. Participant Recruitment and Consent Process

Develop and finalize recruitment strategies for participant enrollment.

Ensure informed consent process is in place and materials are approved by IRB.

Train staff on the consent process and participant engagement strategies.

5. Data Management and Reporting

Establish a data management plan outlining data collection and storage procedures.

Confirm availability of electronic data capture systems and training for staff.

Develop reporting procedures for adverse events and other critical trial data.

6. Safety and Emergency Procedures

Create a safety monitoring plan for tracking adverse events and serious adverse events.

Ensure emergency procedures are established and staff are trained accordingly.

Verify availability of emergency medical supplies on-site.

7. Communication and Coordination

Establish communication channels among all stakeholders (e.g., sponsors, investigators, regulatory bodies).

Set up regular meetings for trial updates and coordination.

Develop a plan for communicating with participants throughout the trial.

8. Financial and Resource Management

Confirm funding and budget allocation for the trial.

Ensure that resources (e.g., personnel, equipment) are adequately financed and available.

Develop a financial tracking system for trial expenditures.

9. Logistics and Supply Chain Management

Ensure a supply chain plan is in place for vaccine and trial materials.

Confirm storage conditions for vaccine and other biopharmaceuticals.

Verify transportation procedures for participants and trial materials.

10. Quality Assurance and Monitoring

Develop a quality assurance plan for site operations and data integrity.

Schedule regular monitoring visits and audits to ensure compliance.

Establish corrective and preventive action plans for any identified issues.