Title: Study Records Collection and Maintenance Introduction and Purpose: The purpose of this SOP is to define the procedures for collecting and maintaining study records in the conduct of clinical research at the clinical site and relevant covered entities. In accordance with FDA regulations and Good Clinical Practice (GCP) guidelines, it is essential to maintain original records of clinical findings, observations, and activities for the reconstruction and evaluation of clinical research studies. Subject-specific records, contained within study participant charts, serve as source documentation of research records. These records encompass various documents such as signed informed consent forms, medical histories, medication logs, treatment records, protocol assessment results, and records of adverse events. Additionally, general study records, including versions of the study protocol and informed consent form, Institutional Review Board (IRB) approvals, investigator's brochures, t...