“The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society”. ICH E6(R2) (2015) reiterates this throughout, and incorporates this sentiment into the roles of many stakeholders, including the IEC, Sponsor and Investigator. These roles have a responsibility and due diligence to protect the safety of trial subjects. CRAs are not exempt from this. ICH E6(R2) (2015) itself lists that the purpose of a monitor is to protect the rights and well-being of human subjects. Therefore, when preparing, conducting and following-up on site monitoring visits, patient safety always takes precedence. To better understand the contribution CRAs make to monitoring safety,
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Compliance with Protocol Monitoring that trial staff are performing the specified trial functions set forth in the Protocol. Continued non-compliance could present a major risk to the well-being and safety of a trial subject. • Source Documentation
• eCRF
• Protocol
• Protocol Deviation Log – reviewed by PI • Protocol Deviation Log – reviewed by PI
As a CRA, protecting subjects’ safety will always be a priority. This sentiment is acted upon throughout various tasks carried out by a CRA including those reviewed in Table 1. However, whilst a CRA does actively contribute towards monitoring safety of a clinical trial, we must acknowledge that ICH E6 (R2) (2015) refers to patient safety, rights and well-being also in relation to the roles of the IRB/IEC and the Investigator. Furthermore, whilst it is not explicitly stated, I believe this could also be associated with the roles of Sponsor Quality Management/Quality Assurance, Inspectors and Auditors. It is due to these contributions from each stakeholder, that we can be certain that patient safety is monitored thoroughly during the lifecycle of a clinical trial. And due to this, I can be confident in not only the safety of the trial subjects, but also the integrity of the data, and the safety of patients who may be exposed to these IPs in the
Compliance with Protocol Monitoring that trial staff are performing the specified trial functions set forth in the Protocol. Continued non-compliance could present a major risk to the well-being and safety of a trial subject. • Source Documentation
• eCRF
• Protocol
• Protocol Deviation Log – reviewed by PI • Protocol Deviation Log – reviewed by PI
As a CRA, protecting subjects’ safety will always be a priority. This sentiment is acted upon throughout various tasks carried out by a CRA including those reviewed in Table 1. However, whilst a CRA does actively contribute towards monitoring safety of a clinical trial, we must acknowledge that ICH E6 (R2) (2015) refers to patient safety, rights and well-being also in relation to the roles of the IRB/IEC and the Investigator. Furthermore, whilst it is not explicitly stated, I believe this could also be associated with the roles of Sponsor Quality Management/Quality Assurance, Inspectors and Auditors. It is due to these contributions from each stakeholder, that we can be certain that patient safety is monitored thoroughly during the lifecycle of a clinical trial. And due to this, I can be confident in not only the safety of the trial subjects, but also the integrity of the data, and the safety of patients who may be exposed to these IPs in the