The landscape of clinical research is rapidly changing, due in large part to technological advances. Differentiate between what you do as a CRA now, in 2017, and what the role of a CRA will look like 10 years from now.
(Response below is 488 words)
The role of CRA will be more office/homebased due to the following reasons. Onsite visits will be performed to confirm that the PI is present, IP and study supplies are maintained and a limited investigator site file is present:
1. SDV: Now, SDV is always performed onsite since many sites are still using paper source documents, paper ICFs, printed reports and printed questionnaires.
In 10 years, source will be electronic and there will be a way to securely transfer data between the site and CRA. This will make SDV an offsite study task. Hospital devices and lab reports will print results that download directly into the EMR as the original and the PI/SI can review and sign electronically. Subject questionnaires will be completed by the subject during the visit on a computer with pin/password access. The informed consent will be documented electronically and will provide a timestamp for the CRA to confirm all study related procedures are performed after consent.
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2. Now, IP accountability is an onsite process that involves pill counting and manual review of the IP. Many CRAs are able to review IXRS to provide an idea of what’s onsite. In 10 years, sites will be able to scan each bottle/vial of IP into the site supply and scan for distribution/destruction. This will provide more accuracy with IP accountability and less onsite visits. The study should provide a temperature monitoring system for IP storage area so the CRA is notified of temperature excursions
(Response below is 488 words)
The role of CRA will be more office/homebased due to the following reasons. Onsite visits will be performed to confirm that the PI is present, IP and study supplies are maintained and a limited investigator site file is present:
1. SDV: Now, SDV is always performed onsite since many sites are still using paper source documents, paper ICFs, printed reports and printed questionnaires.
In 10 years, source will be electronic and there will be a way to securely transfer data between the site and CRA. This will make SDV an offsite study task. Hospital devices and lab reports will print results that download directly into the EMR as the original and the PI/SI can review and sign electronically. Subject questionnaires will be completed by the subject during the visit on a computer with pin/password access. The informed consent will be documented electronically and will provide a timestamp for the CRA to confirm all study related procedures are performed after consent.
o …show more content…
2. Now, IP accountability is an onsite process that involves pill counting and manual review of the IP. Many CRAs are able to review IXRS to provide an idea of what’s onsite. In 10 years, sites will be able to scan each bottle/vial of IP into the site supply and scan for distribution/destruction. This will provide more accuracy with IP accountability and less onsite visits. The study should provide a temperature monitoring system for IP storage area so the CRA is notified of temperature excursions