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Courses in clinical trials

Presenting the Site Feasibility to Sponsors

Feasibility assessment is a critical step in conducting a successful clinical trial. Selecting the right site can be beneficial for both the sponsor and the clinical site. In addition, it can provide an opportunity for many patients to be enrolled in a study that may change their life. Therefore, the…

Note to File in Clinical Studies

A Note to File (NTF) is a record that allows the clinical site and the sponsor to document an identified issue or discrepancy during a clinical study. A NTF should include the following items: ·     The root cause of the discrepancy/issue ·     The corrective action taken to prevent its recurrence ·     Explanation of…

Local labs and Central labs in Clinical Trials

Several clinical trials require specific lab tests. Depending on the study protocol the lab tests are required to establish inclusion and exclusion criteria, monitor the safety of the patients enrolled in the study or demonstrate the efficacy of the investigational product (IP). The sponsor/CRO has two options for gathering clinical…