THE PROCESS OF SELECTING VOLUNTEERS
Subscribe to research: register online by link or instruction in formational.
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Declaring information in research establishments: the volunteers are scheduled to arrive at the Research Center to declare and listen to explanations about the research.
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Signing ICF: After listening to the explanation and understanding about the research, the volunteers sign ICF.
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Health screening: The volunteers are measured height, weight, temperature, blood pressure, pulse rate, respiration rate, and physical examination. Then, the volunteers are taken blood for testing to check the basic parameters of Hematology and Biochemistry.
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List of volunteers: After screening results, the volunteers are FIT with clinical study standard will be included in the list (official volunteers, reserve volunteers). This list will be communicated to volunteers.
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Official research: After the list of volunteers established and announced, the volunteers will officially participate in all periods of the bioequivalence study. The study is usually designed as two-period, each period has at least 1 day of blood collection (24/24h at the clinical research center), may longer (depending on research). The two periods are separated by a washout period of 3 -7 days.
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Health monitoring during the study: the volunteers are used test or reference drug, taken blood from time to time (specified in the protocol) to determine the drug concentration in the blood. During the time of the study, the volunteers are monitored for health, measured Vital signs. If any Adverse Event, the volunteers will be treated promptly.
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Compliance with regulations: In the study, the volunteers must strictly comply with the regulations and intructions of researchers and study protocol.
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Health checks before leaving: At the end of each study period, the volunteers are given health checks and vital signs before leaving.