Clinical Monitoring

MakroCare CRAs perform comprehensive site management and monitoring activities to include the following types of monitoring visits:

• Pre study qualification visits
• Initiation visits
• Interim monitoring visits
• Close out visits

All activities are performed in accordance with ICH-GCP to ensure all investigational sites are compliant with all applicable regulations and protocol requirements.

The paramount responsibility of MakroCare CRAs is to ensure patient rights, safety and data integrity. This is accomplished through ongoing review of the following:

• Informed consent process
• IRB/IEC approval
• Ensuring proper AE and SAE reporting and documented follow up
• Adherence to the protocol
• 100% source documentation verification and data query clarification
• Investigational product administration and accountability
• Protocol Compliance
• Site training and support

MakroCare CRAs ensure ongoing site compliance via the continual ongoing review of Site staff qualifications and experience ; Site staffing, facilities, storage and equipment; Accessibility and eligibility of subjects ; Review and retrieval of regulatory documents ; Accurate and timely completion of all CRF and source data.

In addition to on-site responsibilities each CRA is responsible for site management documentation and follow-up activities to ensure that site staff remains motivated and focused. These activities include the following:

• Site Visit Report and follow-up letters
• Review of safety reports
• Providing site training and support through communications
• Generation of status reports
• Maintenance of tracking tools/logs
• Facilitation of DCF resolution

In summary the MakroCare CRA plays a major role in the successful conduct of a study. The relationship developed between the CRA and the site staff is such that there is a focus on open effective communication with the CRA providing training and support thus ensuring patient safety, data quality and maximizing patient enrolment.