Every clinical trial begins with the development of a clinical protocol. The protocol is a document that describes how a clinical trial will be conducted (the objective, design, methodology, statistical considerations and organization of a clinical trial,) and ensures the safety of the trial subjects and integrity of the data collected.
Investigator Brochure summarizes the relevant to non-clinical and clinical studies data about an investigational product (IP). It includes information regarding IP used in previous non-clinical and clinical studies so that the study investigator and others can have the best guidance. In other words, IB is the compilation of the clinical and nonclinical data on the investigational product relevant to the study of the same product in human subjects. Its purpose is to provide clear information like dose, dose regime, route of administration, known adverse events, and possible drug side effects. This information facilitates safety monitoring in the current study. It provides insight to support the clinical management of the study subjects during the course of the clinical trial. It informs the investigator about the risks and benefits of investigator product know till the day, so that during the study, if any challenge comes up, they can take guidance from IB.
A patient safety narrative provides a full and clinically relevant, chronological account of the progression of an event experienced during or immediately following a clinical study
A clinical study report (CSR) is one of many types of regulatory documents that comprise a marketing application for a drug, biologic, or device. A CSR is a descriptive account of a single clinical trial accompanied by tables, listings, and figures (TLFs) displaying all study data and results. CSR presents a story of clinical trial