Home Clinical Research Visit

Coordination integrity in home patient visit organization is ensured through effective communication between the Principal Investigator, the Center, the site staff, the patient and the service provider. Continuous communication is maintained via phone and e-mail to ensure that all processes are completed accurately from the beginning to the end of the home visit.

In 81 provinces in Turkey, there are more than 250 contracted nurses and more than 90 physicians in the Omega-Care portfolio. Clinical research experience, therapeutic area experience, work experience in special fields such as pediatric or neonatal nursing, and patient communication skills are among the main parameters used in the selection processes of physicians and nurses.

After receiving the signed 'Physician Request Form' (PoF) from the Principal Investigator at the clinical research center regarding conducting a home visit to the research volunteer, the home visit program is created. Visit dates can be changed and unscheduled visits can be added by the Principal Investigator according to the volunteer's health condition.

The nurse and a backup to be assigned in the province where the research volunteer is located are carefully selected from the Omega-Care portfolio. Nurse authorization is completed before the first visit following the applications and notifications to be made to TITCK and the Ethics Committee. Trainings include GCP, IATA/DGR, protocol, laboratory and source documentation trainings.

Within the home visit planning, courier and customs procedures are planned for the transfer of biological materials to be taken from the volunteer to domestic and international central laboratories and made ready for transfer.

All materials and supplies, such as protective equipment to be used by the nurse during home visits, devices required for measuring the patient's vital signs (blood pressure monitor, thermometer, oximeter, scale, ECG, etc.), laboratory sample containers, centrifuge, and source documents, are prepared before the visit and delivered to the nurse before the home visit.

If deemed necessary in the research protocol, the delivery of the research product to the volunteer and monitoring of its use are provided by the nurse. Transfer procedures are defined in the Omega-Care research product transfer SOP.

In accordance with the study protocol and the 'Physician Request Form', biological materials such as blood and urine taken from the volunteer are prepared to be transferred in accordance with IATA rules or UN3373 and delivered to the courier arriving at the volunteer's home at the determined time. The source document is filled in completely by the nurse; medical waste is collected in accordance with the relevant SOP.

The source document prepared in accordance with the study protocol is sent electronically to the "Home Visit Coordinator" for checking after the visit. The source document checked by the coordinator is sent to the center by e-mail within 24 hours, and the original is sent to the center by cargo within 48 hours.