Clinical Research is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical Research is different than clinical practice. In clinical practice, one used established treatments while in clinical research evidence is collected to establish a treatment. This GIHS Clinical Research Program designed to provide total overview and skill globally in the field of clinical research. It would help professionals to upgrade & develop their knowledge about ICH GCP Guidelines, regulatory issues and other major aspects of clinical research & trial management. An Audit is a “systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analysed and accurately reported according to the protocol, sponsor’s SOPs, GCP, and the applicable regulatory requirements.” An Inspection is “an act by a Competent Authority of conducting an official review of documents, facilities, records and other resources that are deemed by the competent authority to be related to the clinical trial and that may be located at the trial site, at the sponsor and/or contract research organisation’s facilities or at other establishments deemed appropriate by the Regulatory Authority.” This program deals with preparation for audits and inspections.