Oversight of clinical investigations by sponsors and clinical research organizations (CROs) is critical to the protection of human subjects and the conduct of high-quality studies. Clinical investigations involving human drugs, biological products, and medical devices, require effective monitoring to provide oversight and to ensure adequate protection of the rights, welfare, and safety of human subjects as well as the quality of the clinical trial data submitted to regulatory authorities. Risk assessment analysis of a clinical study can vary dramatically. Having the ability to easily modify approaches to monitoring activities based on risk provides an efficient use of resources as well as a higher quality of study data.
A high quality monitoring plan will dictate the frequency and duration of the visits as well as the “risk areas” a monitor should focus on for each study. Ensuring a site has acquired the necessary approvals, complete study documentation, is adequately trained on the protocol, and that the investigator fully understands his/her responsibilities will increase the quality and compliance of the overall study. Additionally, a formal clinical site closeout procedure ensures that all parties are well informed of the conclusion of the study and that all parties involved are well informed of the overall reason for and outcomes of the study.