Clinical Research Online Course
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…
Based on ICH-GCP guidelines definition, essential documents are “those documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced”. In order to successfully manage a clinical trial, it is critical to file the essential documents in a timely manner. The…
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…