Following my assignment as one of the CRAs on a large phase III lung cancer trial to conduct a pre-study site evaluation visit with Professor Chan, and having received the valuable information from my colleague on the multiple findings after Competent Authority inspection last year at this site, I will have to plan the visit carefully to focus on the areas of potential weakness and conduct the visit accordingly.
First of all, I will schedule the visit 2 to 3 weeks beforehand to ensure all potential site staff be present: PI, Sub-Investigators and Medical Nurses. I will call Professor Chan and discuss the plan of the visit: facilities planned to be visited, tools and equipment to be checked according to the Protocol, site staff training and experience, the internal process of the clinical …show more content…
How SAEs/AEs are assessed by Investigators and how they are reported including timeframe
7. How blinding is kept and what are preventive measures taken by site about it
I will certainly discuss other things like ICF process, work with biological samples, IP accountability, timelines of eCRF completion and queries resolution, ISF maintenance, IRB/IEC, Internet access and security for site computers, calibration certificates, will perform presentation and review requirements of the study Protocol and point out inclusion/exclusion criteria for patients etc., appropriate workspace and internet access for the CRA; will perform facility tour, find out about Investigators training, experience, will sign and collect needed documents etc. , all activities according to PSSV agenda.
The key point which will influence my recommendation for using this site or not will be the way work is organized at the site, the level of qualification of site staff and their interest and availability to conduct the study.
In case there are still some weaknesses, but a well understanding of the process and high motivation and readiness to improve, I will recommend the site to participate in the
First of all, I will schedule the visit 2 to 3 weeks beforehand to ensure all potential site staff be present: PI, Sub-Investigators and Medical Nurses. I will call Professor Chan and discuss the plan of the visit: facilities planned to be visited, tools and equipment to be checked according to the Protocol, site staff training and experience, the internal process of the clinical …show more content…
How SAEs/AEs are assessed by Investigators and how they are reported including timeframe
7. How blinding is kept and what are preventive measures taken by site about it
I will certainly discuss other things like ICF process, work with biological samples, IP accountability, timelines of eCRF completion and queries resolution, ISF maintenance, IRB/IEC, Internet access and security for site computers, calibration certificates, will perform presentation and review requirements of the study Protocol and point out inclusion/exclusion criteria for patients etc., appropriate workspace and internet access for the CRA; will perform facility tour, find out about Investigators training, experience, will sign and collect needed documents etc. , all activities according to PSSV agenda.
The key point which will influence my recommendation for using this site or not will be the way work is organized at the site, the level of qualification of site staff and their interest and availability to conduct the study.
In case there are still some weaknesses, but a well understanding of the process and high motivation and readiness to improve, I will recommend the site to participate in the