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Home Clinical Trial Visit
Omega Research carries its 25 years of experience in clinical research from research centers to volunteers’ homes with its “Home Clinical Research” services.
Clinical research, which plays an important role in the development of health services and increasing the quality of patient care, requires a disciplinary team work from planning to conducting, from conclusion to reporting.
Evaluation of vital signs at home, application of necessary questionnaires, blood/urine collection, delivery of research product to volunteers, drug counting, detection and reporting of adverse events, sending the sample from home to the central laboratory services are performed by experienced nurses or, if necessary, physicians.
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1. EFFECTIVE COMMUNICATION
Coordination unity in the organization of home patient visits is provided by effective communication between the Principle Investigating Physician, Center, SC, patient, and service provider. Continuous communication via phone and e-mail is maintained throughout the entire process of the home visit to ensure that all processes are completed correctly and without errors. Continuous communication ensures that the home visit is completed quickly and safely.
2. HOME VISIT TEAM
In Turkey, there are 260 nurses and 95 doctors in the Omega-Care portfolio in 81 cities. Clinical trial experience, therapeutic area experience, pediatric or neonatal nursing experience in special fields, and patient communication skills are among the main parameters used in the selection process for physicians and nurses. Our doctors, nurses, and other healthcare professionals have actively participated in many clinical trial studies and are members of the ideal team for new clinical trials.
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3. PLANNING OF HOME VISIT
After obtaining a signed “Physician Request Form” (PoF) from the Principle Investigator (PI) at the clinical trial center, the home visit program is created. Home visits are planned using the current, signed PoF that is electronically transmitted to Omega-Care. The visit dates can be changed and unscheduled visits can be added according to the health condition of the subjects, by the Principle Investigator. In such cases, the visit program is re-created and electronically transmitted to Omega-Care, and the home visit team is immediately informed and the visit is carried out on the desired date.
4. DETERMINATION, AUTHORIZATION, AND TRAINING OF THE HOME VISIT TEAM
The nurse and co-nurse to be assigned in the city where the study subject is located are carefully selected from the Omega-Care portfolio. Nurse authorization is completed before the first visit after the submission and notification submitted to TİTCK and the Ethical Committee. The home visit team is trained within the procedures and protocols specific to the study before the first visit, including “Good Clinical Practices (GCP) Training”, “International Air Transport Association (IATA) and Dangerous Goods Regulation (DGR) Training”, “Clinical Trial Study Protocol Training”, “Laboratory Training”, and “Source Documentation Training”.
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5. PLANNING OF BIOLOGICAL MATERIAL TRANSFER
During the home visit planning, courier and customs procedures are planned to transfer biological materials collected from the subject to local and international center laboratories.
6. PROVIDING HOME VISIT MATERIALS
Protective equipment for the nurse to use, devices necessary for measuring the patient’s vital signs as defined in the study protocol (blood pressure cuff, thermometer, oximeter, scale, ECG, etc.), sample containers for laboratory tests (blood tubes, urine cups, etc.), centrifuge, source documentation, etc., are all prepared and provided to the nurse before the home visit. These materials can vary for each clinical trial study, so they are procured according to the study protocol during the preparation phase.
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7. TRANSFER OF STUDY PRODUCT
If required by the study protocol, the nurse is responsible for delivering and monitoring the use of the study product to the subject. The transfer procedures to be used during the delivery of the study product are defined in the Omega-Care study product transfer SOP.
8. CONDUCTING HOME VISITS
Biological materials such as blood and urine collected from the subject according to the study protocol and the “Doctor Request Form” are prepared and handed over to the courier arriving at the subject’s home at a designated time, for transfer in accordance with IATA regulations. During the visit, the source documentation containing patient observations, vital sign recordings, adverse event tracking, and information on the use of the study product is filled out completely by the nurse. The nurse informs the subject about the next home visit date at the end of the visit. The nurse also collects all medical waste according to the relevant SOP and leaves the subject’s home.
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9. SOURCE DOCUMENTATION AND MANAGEMENT
The source documentation prepared according to the study protocol is sent electronically to the “Home Visit Coordinator” for review after the visit. The source documentation reviewed by the Home Visit Coordinator is sent to the center via e-mail within 24 hours. After the original source documentation is approved by the Center Site Coordinator for being correct and complete, it is sent to the center via cargo within 48 hours.
You can fill out the Clinical Research Support Services Form.
Please fill out the form on the side so that we can better understand the details such as the research protocol, the number of centers and related cities, and the procedures to be performed during home visits. Our Omega Care team will contact you as soon as possible.
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