1. Identify and describe the 3 different means to evaluate on-site study conduct. Include the responsible party and driver of each means. How are these means complicated by including both domestic and foreign trial sites, if at all?
The three different means to evaluate on-site study conduct are Routine Monitoring Visits (RMV), Audit and Inspection. The common driver of the three means are to ensure the safety of products. The responsible parties for RMV would be as more as sponsor, CRA (performs as a clinical monitor), PI, Pharmacist, researchers and other staffs. The driver of RMV are to identify whether there are any new safety problems, to review every steps of the whole process, to make sure the Regulatory Compliance (compliance to any …show more content…
People from different places consider different reasons on participating clinical trials; subjects from impoverished places may attend for better treatment or reimbursement. Sponsors can provide short training or knowledge spreading meetings to let subjects have a general concept of the trial before they sign ICFs.
(4) Physicians Recommendation
Physicians are not likely to refer patients to participate clinical trials while many patients will ask for recommendation or clinical trial information. This situation will be improved if physicians are provided more updated and latest clinical trial information, what’s more, another better way is to create a networked or researchable database for physician to obtain latest information.
(5) Racial Recruitment Problem
Some minorities present a willing of not participating clinical trials. To gain their cooperation, sponsors can recruit more minority staffs, speak their languages; for some community society, sponsor can contact with community elders first to gain help from them to organize members learn about clinical
The three different means to evaluate on-site study conduct are Routine Monitoring Visits (RMV), Audit and Inspection. The common driver of the three means are to ensure the safety of products. The responsible parties for RMV would be as more as sponsor, CRA (performs as a clinical monitor), PI, Pharmacist, researchers and other staffs. The driver of RMV are to identify whether there are any new safety problems, to review every steps of the whole process, to make sure the Regulatory Compliance (compliance to any …show more content…
People from different places consider different reasons on participating clinical trials; subjects from impoverished places may attend for better treatment or reimbursement. Sponsors can provide short training or knowledge spreading meetings to let subjects have a general concept of the trial before they sign ICFs.
(4) Physicians Recommendation
Physicians are not likely to refer patients to participate clinical trials while many patients will ask for recommendation or clinical trial information. This situation will be improved if physicians are provided more updated and latest clinical trial information, what’s more, another better way is to create a networked or researchable database for physician to obtain latest information.
(5) Racial Recruitment Problem
Some minorities present a willing of not participating clinical trials. To gain their cooperation, sponsors can recruit more minority staffs, speak their languages; for some community society, sponsor can contact with community elders first to gain help from them to organize members learn about clinical