Standard Operating Procedure (SOP) and Translational Reserach

Good Clinical Practice (GCP) is "a standard for the design, conduct, performance, monitoring, auditing,recording, analysis, and reporting of clinical trials or studies." SOPs are "detailed, written instructions to achieve uniformity of the performance of a specific function" (ICH GCP 1.55) that serve as an important tool for implementing GCP standards. Biopharmaceutical companies and CROs have a long history of implementing quality assurance systems with SOPs to ensure that their clinical trials are performed in compliance with the national and international regulations and fast delivery of new medicinal products. Any deviation from an SOP has to be explained and justified in order to ensure safety of research subjects,integrity of data, and accountability of personnel at all levels of clinical research. Investigator-initiated trials are the major component of academic medical centers system translational clinical research programs. Clinical research differs significantly from daily medical practice and requires an investment in personnel, process, training and time. Many investigator-sponsors lack pharmaceutical sponsor expertise for "implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s)" (ICH GCP 5.1.1). Implementing of such quality assurance systems in research studies involving human subjects in an academic research setting presents many challenges. In addition, there are no clear guidelines or regulations for quality assurance and quality control for non-interventional/non-therapeutic (non-GCP) studies such as observation, registries, and cohort studies, as well as specimen collection involving human subjects [3]. Thus it is important for the institution to support and train investigators and research staff so that SOPs are used for all levels of clinical studies to ensure that the welfare of study subjects is protected and compliance of GCP guidelines and FDA regulations are met.